New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration said today.
Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug.
Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines.
“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Alternative medications that have a lower risk of birth defects should be considered.”
Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections. Surgery often is performed to close the lip and palate and most children do well after treatment.
Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent – 0.55 percent in infants exposed to other antiepileptic drugs.
Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent. Similar data from the United Kingdom Epilepsy and Pregnancy Register supported the North American AED Pregnancy Registry data.
Based on the data, topiramate will have a stronger warning in its prescribing information (labeling). The pregnancy category will be changed to Pregnancy Category D. This means that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations. The FDA previously designated the drug as Pregnancy Category C because of the lack of human data. More information about the Pregnancy Categories can be found in the FDA’s Drug Safety Communication1.
The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.
Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional.
Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry2, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.
-----
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Showing posts with label toxic. Show all posts
Showing posts with label toxic. Show all posts
Friday, March 04, 2011
Monday, February 28, 2011
Smoking Early in Pregnancy Raises Risk of Heart Defects in Infants
Maternal cigarette smoking in the first trimester was associated with a 20 to 70 percent greater likelihood that a baby would be born with certain types of congenital heart defects, according to a study by the Centers for Disease Control and Prevention. Congenital heart defects are the most common type of birth defects, contributing to approximately 30 percent of infant deaths from birth defects annually.
The study found an association between tobacco exposure and certain types of defects such as those that obstruct the flow of blood from the right side of the heart into the lungs (right ventricular outflow tract obstructions) and openings between the upper chambers of the heart (atrial septal defects). The study is in the Feb. 28 issue of the journal Pediatrics.
"Women who smoke and are thinking about becoming pregnant need to quit smoking and, if they're already pregnant, they need to stop," said CDC Director Thomas R. Frieden, M.D., M.P.H. "Quitting is the single most important thing a woman can do to improve her health as well as the health of her baby."
Based on the findings of this and other studies, eliminating smoking before or very early in pregnancy could prevent as many as 100 cases of right ventricular outflow tract obstructions and 700 cases of atrial septal defects each year in the United States. For atrial septal defects alone, that could potentially save $16 million in hospital costs.
"Successfully stopping smoking during pregnancy also lowers the chances of pregnancy complications such as preterm delivery and that an infant will have other complications such as low birth weight," said Adolfo Correa, M.D., Ph.D., medical officer in CDC′s National Center on Birth Defects and Developmental Disabilities.
The findings from the study, "Maternal Smoking and Congenital Heart Defects in the Baltimore-Washington Infant Study," are based on a large population-based case-control study of congenital heart defects conducted in the United States; 2,525 case and 3,435 control infants born from 1981 to 1989 were included in this analysis.
Congenital heart defects are conditions present at birth that decrease the ability of the heart to work well, which can result in an increased likelihood of death or long-term disabilities. They affect nearly 40,000 infants in the United States every year.
It is estimated that right ventricular outflow tract obstructions affect approximately 2,500 infants per year and atrial septal defects affect approximately 5,600 infants per year in the United States. In 2004, U.S. hospital costs for all congenital heart defects were estimated at approximately $1.4 billion.
Source: PRNewswire
-----
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The study found an association between tobacco exposure and certain types of defects such as those that obstruct the flow of blood from the right side of the heart into the lungs (right ventricular outflow tract obstructions) and openings between the upper chambers of the heart (atrial septal defects). The study is in the Feb. 28 issue of the journal Pediatrics.
"Women who smoke and are thinking about becoming pregnant need to quit smoking and, if they're already pregnant, they need to stop," said CDC Director Thomas R. Frieden, M.D., M.P.H. "Quitting is the single most important thing a woman can do to improve her health as well as the health of her baby."
Based on the findings of this and other studies, eliminating smoking before or very early in pregnancy could prevent as many as 100 cases of right ventricular outflow tract obstructions and 700 cases of atrial septal defects each year in the United States. For atrial septal defects alone, that could potentially save $16 million in hospital costs.
"Successfully stopping smoking during pregnancy also lowers the chances of pregnancy complications such as preterm delivery and that an infant will have other complications such as low birth weight," said Adolfo Correa, M.D., Ph.D., medical officer in CDC′s National Center on Birth Defects and Developmental Disabilities.
The findings from the study, "Maternal Smoking and Congenital Heart Defects in the Baltimore-Washington Infant Study," are based on a large population-based case-control study of congenital heart defects conducted in the United States; 2,525 case and 3,435 control infants born from 1981 to 1989 were included in this analysis.
Congenital heart defects are conditions present at birth that decrease the ability of the heart to work well, which can result in an increased likelihood of death or long-term disabilities. They affect nearly 40,000 infants in the United States every year.
It is estimated that right ventricular outflow tract obstructions affect approximately 2,500 infants per year and atrial septal defects affect approximately 5,600 infants per year in the United States. In 2004, U.S. hospital costs for all congenital heart defects were estimated at approximately $1.4 billion.
Source: PRNewswire
-----
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Wednesday, January 26, 2011
FDA Review Indicates Possible Association Between Breast Implants and a Rare Cancer
/PRNewswire/ -- The U.S. Food and Drug Administration today announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.
The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.
In an effort to ensure that patients receiving breast implants are informed of the possible risk, FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals.
"We need more data and are asking that health care professionals tell us about any confirmed cases they identify," said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA's Center for Devices and Radiological Health. "We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants."
According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.
In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants.
The FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.
Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (peri-implant seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis.
The FDA is recommending that health care professionals and women pay close attention to breast implants and do the following:
* Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA's safety information and adverse event reporting program. Report online at http://www.fda.gov/Safety/MedWatch/default.htm or by calling 800-332-1088.
* Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
* There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, health care providers should follow standard medical recommendations.
* Women should monitor their breast implants and contact their doctor if they notice any changes.
* Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.
The FDA published its literature review in a document posted on FDA's website site today titled "Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses."
The FDA also plans to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.
For more information:
ALCL and Breast Implants
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm
Breast Implant Consumer Information
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063717.htm
ALCL and Breast Implants Consumer Article
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm240985.htm
-----
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The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.
In an effort to ensure that patients receiving breast implants are informed of the possible risk, FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals.
"We need more data and are asking that health care professionals tell us about any confirmed cases they identify," said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA's Center for Devices and Radiological Health. "We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants."
According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.
In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants.
The FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.
Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (peri-implant seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis.
The FDA is recommending that health care professionals and women pay close attention to breast implants and do the following:
* Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA's safety information and adverse event reporting program. Report online at http://www.fda.gov/Safety/MedWatch/default.htm or by calling 800-332-1088.
* Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
* There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, health care providers should follow standard medical recommendations.
* Women should monitor their breast implants and contact their doctor if they notice any changes.
* Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.
The FDA published its literature review in a document posted on FDA's website site today titled "Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses."
The FDA also plans to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.
For more information:
ALCL and Breast Implants
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm
Breast Implant Consumer Information
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063717.htm
ALCL and Breast Implants Consumer Article
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm240985.htm
-----
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Tuesday, January 18, 2011
Bath Salts: For Bathing or the Latest High?
/PRNewswire/ -- Some bath salts – with names like Ocean Burst and Ivory Wave – aren't really for bathing. Rather, they are the latest high for naive teens and young adults as well as established drug abusers.
"Fake cocaine and fake meth are laced in bath salts and sold legally on the Internet and in convenience stores, gas stations, truck stops and head shops in most states. This newest boutique chemical substance is being used for a narcotic effect and often sends users to emergency rooms," warns Greg L. Jones, M.D., addiction medicine physician at Willingway Hospital, an alcohol and drug abuse treatment center in Statesboro, Ga.
According to Dr. Jones, manufacturers are using engineered molecules similar to controlled substances in the fake bath salts, which are labeled 'not for consumption,' to skirt the law. The molecules are derivatives of two controlled substances –MDPV (methylenedioxypyrovalerone, which is similar to Ritalin, but more potent) and mephedrone (an amphetamine-like drug). Also known as party salts and party powders, fake bath salts are snorted or ingested to create a stimulant, narcotic effect like that of cocaine.
"Users are snorting and ingesting the fake bath salts as a stimulant, to create a sense of euphoria and to stay up and party longer," Dr. Jones explains. "However, it can increase pulse and blood pressure to dangerous levels and cause delirium and confusion."
People using the bath salts as a narcotic have been treated for paranoia, hallucinations, agitation, hypertension, chest pain and headaches.
"Drug-naive teens and college students are showing up in ERs across the country because they purchased and used these products. They probably think that since they didn't buy them from a drug-dealer that they aren't as dangerous as the real thing, so they load up on them and reach a toxic state," Dr. Jones said.
As attention is being drawn to this latest drug abuse fad, Dr. Jones predicts that, as Willingway Hospital is now doing, facilities will be adding questions about use of party powders and fake bath salts to their drug and alcohol history questionnaires. And, more prevalent use is leading to a ban of these products, such as in Louisiana where two weeks ago, Governor Bobby Jindal announced that the so-called bath salts are now defined as illegal narcotics under State of Louisiana law.
-----
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"Fake cocaine and fake meth are laced in bath salts and sold legally on the Internet and in convenience stores, gas stations, truck stops and head shops in most states. This newest boutique chemical substance is being used for a narcotic effect and often sends users to emergency rooms," warns Greg L. Jones, M.D., addiction medicine physician at Willingway Hospital, an alcohol and drug abuse treatment center in Statesboro, Ga.
According to Dr. Jones, manufacturers are using engineered molecules similar to controlled substances in the fake bath salts, which are labeled 'not for consumption,' to skirt the law. The molecules are derivatives of two controlled substances –MDPV (methylenedioxypyrovalerone, which is similar to Ritalin, but more potent) and mephedrone (an amphetamine-like drug). Also known as party salts and party powders, fake bath salts are snorted or ingested to create a stimulant, narcotic effect like that of cocaine.
"Users are snorting and ingesting the fake bath salts as a stimulant, to create a sense of euphoria and to stay up and party longer," Dr. Jones explains. "However, it can increase pulse and blood pressure to dangerous levels and cause delirium and confusion."
People using the bath salts as a narcotic have been treated for paranoia, hallucinations, agitation, hypertension, chest pain and headaches.
"Drug-naive teens and college students are showing up in ERs across the country because they purchased and used these products. They probably think that since they didn't buy them from a drug-dealer that they aren't as dangerous as the real thing, so they load up on them and reach a toxic state," Dr. Jones said.
As attention is being drawn to this latest drug abuse fad, Dr. Jones predicts that, as Willingway Hospital is now doing, facilities will be adding questions about use of party powders and fake bath salts to their drug and alcohol history questionnaires. And, more prevalent use is leading to a ban of these products, such as in Louisiana where two weeks ago, Governor Bobby Jindal announced that the so-called bath salts are now defined as illegal narcotics under State of Louisiana law.
-----
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Wednesday, January 12, 2011
Survey: Exposure to Anti-Drug Messages Among Teens Drops Dramatically by Two-Thirds as Drug Use Goes Up
/PRNewswire/ -- The University of Michigan's Monitoring the Future study (MTF) – the largest survey on teen drug abuse tracking over 46,000 8th, 10th and 12th graders – found a huge falloff in teens' recalled exposure to drug abuse prevention messages over the past seven years. The new data from the MTF study have been released at a time when teens themselves report finding the drug-prevention messages to be effective.
Comparing 2003, the year in which kids and teens' recalled exposure to drug prevention messages from the White House Office of National Drug Control Policy (ONDCP)'s National Youth Anti-Drug Media Campaign (NYADMC) peaked, to today, the proportion of 8th graders that reported daily/or more often exposure dropped from 54 percent to 18 percent, a dramatic decrease of two-thirds among the youngest group surveyed. Similar declines occurred among 10th graders (50 percent in 2003 to 17 percent in 2010) and 12th graders (32 percent to 10 percent). According to Lloyd Johnston, the principal investigator of the study, the rates of teens' recalled exposure of drug abuse prevention messages are lower in 2010 than they have been since his research team began tracking all three grades nearly two decades ago.
"At a time when teen drug use is at relatively low levels, historically, and children are not learning as much through the news media about the health consequences of using many dangerous drugs, it is important that we get that information to them by other means – through prevention ads, in schools and through their families," said Johnston. "If they don't get those messages, teens will come to view drug use as less dangerous than their predecessors did and that misconception will leave them vulnerable to having their own epidemics of drug abuse. In fact, we are already seeing these signs beginning to happen now for teen use of drugs like marijuana, Ecstasy and LSD."
Support for prevention programs like the state grants portion of the Safe and Drug-Free Schools and Communities Program, which was zeroed out in the 2011 budget, and the federal NYADMC, has dwindled significantly over the past decade. In fiscal year 2003, which marked the peak year for recalled exposure of drug abuse prevention messages among teens, federal support of the NYADMC was $145 million, compared to only $45 million for fiscal year 2010. The kinds of extracurricular activities – programs in sports, civics and the arts – that states and localities have funded to engage kids' positive energies and help prevent substance abuse continue to collapse under relentless budgetary pressure.
"Our prevention infrastructure is disappearing before our eyes and the result of all this is not fair, but it's undeniable: the additional burden is increasingly falling on the shoulders of parents and caregivers," said Steve Pasierb, President of The Partnership at Drugfree.org. "The slashing of funds and lack of support, coupled with the discussion of further cuts for effective prevention programs, are going to have a direct impact on the 35 million American families with children at risk of abusing drugs or alcohol."
Teens Seeing/Hearing Less Drug-Prevention Messages, But Find Them Effective
While recalled exposure among teens is down significantly, perceived effectiveness of the drug-prevention messages did not reflect the same dramatic drops and, for the most part, remained constant. Between 2003 and today, the proportion of 8th, 10th, and 12th graders that agreed "the commercials made them, to a great extent, less favorable toward drugs" remained fairly stable. Among 8th graders, 42 percent in 2003 and 36 percent in 2010; among 10th graders, 26 percent in 2003 and 23 percent in 2010; and among 12th graders 22 percent in 2003 and 21 percent in 2010.
Similarly, the percentage of teens who agreed that drug-prevention messages made them less likely to use drugs in the future also remained stable, although they reported they are exposed to fewer messages.
"There is evidence of a correlation between decreased drug use among teens and their exposure to drug abuse prevention messages," said Pasierb. "The alarming drops in the number of messages teens are seeing or hearing today is especially disturbing because the kids themselves report these messages are effective in keeping them from using drugs."
Increases in Teen Use of Illicit Drugs Correlate with Decreased Support for Anti-Drug Messages
The MTF survey also measures teen attitudes about drug and alcohol use, including perceived harmfulness and disapproval, factors that can predict future substance abuse. The perception among teens that regular marijuana use is harmful decreased among 10th and 12th graders, but declined the most among the youngest group of 8th graders. The study also confirmed a new uptick in teen Ecstasy use, especially, among 8th and 10th graders, following drastic declines of this drug of abuse over the past decade. As teen anti-drug attitudes erode and move in the wrong direction, increases in drug use are sure to follow.
"While we recognize the current constraints on the federal budget, we urge Congress to fund ONDCP's National Youth Media Campaign at the highest possible level and restore the funding cuts that have eroded the impact of this program and have most likely contributed to increases in teen drug abuse," said Pasierb. "We would welcome the opportunity to work with Congress and the Administration to increase the frequency with which teens receive anti-drug messages, while demanding full accountability for the program and its outcomes."
The National Youth Anti-Drug Media Campaign, administered by ONDCP, is aimed at reducing drug use among American teens. The Partnership at Drugfree.org assists in facilitating the creative development of the drug abuse prevention messages used by the NYADMC.
To learn more about how to help parents prevent, intervene in and find treatment for drug and alcohol use by their children, please visit drugfree.org
-----
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Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
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Twitter: @artsacrossga, @softnblue, @RimbomboAAG @FayetteFP
Comparing 2003, the year in which kids and teens' recalled exposure to drug prevention messages from the White House Office of National Drug Control Policy (ONDCP)'s National Youth Anti-Drug Media Campaign (NYADMC) peaked, to today, the proportion of 8th graders that reported daily/or more often exposure dropped from 54 percent to 18 percent, a dramatic decrease of two-thirds among the youngest group surveyed. Similar declines occurred among 10th graders (50 percent in 2003 to 17 percent in 2010) and 12th graders (32 percent to 10 percent). According to Lloyd Johnston, the principal investigator of the study, the rates of teens' recalled exposure of drug abuse prevention messages are lower in 2010 than they have been since his research team began tracking all three grades nearly two decades ago.
"At a time when teen drug use is at relatively low levels, historically, and children are not learning as much through the news media about the health consequences of using many dangerous drugs, it is important that we get that information to them by other means – through prevention ads, in schools and through their families," said Johnston. "If they don't get those messages, teens will come to view drug use as less dangerous than their predecessors did and that misconception will leave them vulnerable to having their own epidemics of drug abuse. In fact, we are already seeing these signs beginning to happen now for teen use of drugs like marijuana, Ecstasy and LSD."
Support for prevention programs like the state grants portion of the Safe and Drug-Free Schools and Communities Program, which was zeroed out in the 2011 budget, and the federal NYADMC, has dwindled significantly over the past decade. In fiscal year 2003, which marked the peak year for recalled exposure of drug abuse prevention messages among teens, federal support of the NYADMC was $145 million, compared to only $45 million for fiscal year 2010. The kinds of extracurricular activities – programs in sports, civics and the arts – that states and localities have funded to engage kids' positive energies and help prevent substance abuse continue to collapse under relentless budgetary pressure.
"Our prevention infrastructure is disappearing before our eyes and the result of all this is not fair, but it's undeniable: the additional burden is increasingly falling on the shoulders of parents and caregivers," said Steve Pasierb, President of The Partnership at Drugfree.org. "The slashing of funds and lack of support, coupled with the discussion of further cuts for effective prevention programs, are going to have a direct impact on the 35 million American families with children at risk of abusing drugs or alcohol."
Teens Seeing/Hearing Less Drug-Prevention Messages, But Find Them Effective
While recalled exposure among teens is down significantly, perceived effectiveness of the drug-prevention messages did not reflect the same dramatic drops and, for the most part, remained constant. Between 2003 and today, the proportion of 8th, 10th, and 12th graders that agreed "the commercials made them, to a great extent, less favorable toward drugs" remained fairly stable. Among 8th graders, 42 percent in 2003 and 36 percent in 2010; among 10th graders, 26 percent in 2003 and 23 percent in 2010; and among 12th graders 22 percent in 2003 and 21 percent in 2010.
Similarly, the percentage of teens who agreed that drug-prevention messages made them less likely to use drugs in the future also remained stable, although they reported they are exposed to fewer messages.
"There is evidence of a correlation between decreased drug use among teens and their exposure to drug abuse prevention messages," said Pasierb. "The alarming drops in the number of messages teens are seeing or hearing today is especially disturbing because the kids themselves report these messages are effective in keeping them from using drugs."
Increases in Teen Use of Illicit Drugs Correlate with Decreased Support for Anti-Drug Messages
The MTF survey also measures teen attitudes about drug and alcohol use, including perceived harmfulness and disapproval, factors that can predict future substance abuse. The perception among teens that regular marijuana use is harmful decreased among 10th and 12th graders, but declined the most among the youngest group of 8th graders. The study also confirmed a new uptick in teen Ecstasy use, especially, among 8th and 10th graders, following drastic declines of this drug of abuse over the past decade. As teen anti-drug attitudes erode and move in the wrong direction, increases in drug use are sure to follow.
"While we recognize the current constraints on the federal budget, we urge Congress to fund ONDCP's National Youth Media Campaign at the highest possible level and restore the funding cuts that have eroded the impact of this program and have most likely contributed to increases in teen drug abuse," said Pasierb. "We would welcome the opportunity to work with Congress and the Administration to increase the frequency with which teens receive anti-drug messages, while demanding full accountability for the program and its outcomes."
The National Youth Anti-Drug Media Campaign, administered by ONDCP, is aimed at reducing drug use among American teens. The Partnership at Drugfree.org assists in facilitating the creative development of the drug abuse prevention messages used by the NYADMC.
To learn more about how to help parents prevent, intervene in and find treatment for drug and alcohol use by their children, please visit drugfree.org
-----
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www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
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Monday, December 20, 2010
Fed Delays on Alcohol Labeling Stymieing National Policies on Alcohol and Obesity
/PRNewswire/ -- The National Consumers League (NCL) has once again called on the Alcohol and Tobacco Tax and Trade Bureau (TTB) to issue a final rule to improve alcohol beverage labeling.
"The drinking public needs certain basic information on beer, wine, and spirits labels," said NCL Executive Director Sally Greenberg. "With a severe nationwide obesity epidemic, there is no excuse for not having calories listed on all alcohol beverage labels. Consumers also need clear information about alcohol content in order to drink responsibly."
Seven years ago, the National Consumers League petitioned TTB to require an "Alcohol Facts" panel on labels of beer, wine, and distilled spirits. More than 3 years ago, TTB proposed a watered-down version of "Alcohol Facts," which it called "Serving Facts," but has still not issued a final rule.
"The Alcohol Facts panel was intended to provide all the information consumers need in one location, clearly and concisely," said Greenberg. "It would be like the Nutrition Facts panel on food labels, except that it would provide the information relevant to alcoholic beverages." NCL asked that the "Alcohol Facts" panel include serving size, the number of calories per serving, alcohol content information (including the amount of alcohol per serving, the definition of a "standard drink," and the number of standard drinks per container), and ingredient information.
"The nine college students who went to an emergency room for alcohol poisoning after drinking too much of a caffeinated alcoholic beverage earlier this year may not have realized just how much alcohol they were consuming," added Greenberg. "Maybe if the standard drinks per container had been required to appear on the labels, they wouldn't have made that mistake."
TTB's inaction on Alcohol Facts labeling is also interfering with other important public health objectives. A new law requires nutrition labeling of foods and beverages served in chain restaurants and bars, including alcoholic beverages, but there is no approved method for measuring certain nutrients in alcohol and TTB has provided the industry with no guidance. If the Alcohol Facts panel were required, restaurants and bars could simply use the information on the product label.
The lack of calorie and alcohol information on beer, wine, and spirits labels is also an obstacle to application of the Dietary Guidelines for Americans. The Departments of Agriculture and Health and Human Services will soon issue the 2010 Dietary Guidelines, but, without calorie and alcohol information on product labels, consumers still will not be able to follow its recommendations on weight control and alcohol consumption.
"Label reform for alcoholic beverages is a no brainer," according to Greenberg. "What is TTB waiting for?"
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"The drinking public needs certain basic information on beer, wine, and spirits labels," said NCL Executive Director Sally Greenberg. "With a severe nationwide obesity epidemic, there is no excuse for not having calories listed on all alcohol beverage labels. Consumers also need clear information about alcohol content in order to drink responsibly."
Seven years ago, the National Consumers League petitioned TTB to require an "Alcohol Facts" panel on labels of beer, wine, and distilled spirits. More than 3 years ago, TTB proposed a watered-down version of "Alcohol Facts," which it called "Serving Facts," but has still not issued a final rule.
"The Alcohol Facts panel was intended to provide all the information consumers need in one location, clearly and concisely," said Greenberg. "It would be like the Nutrition Facts panel on food labels, except that it would provide the information relevant to alcoholic beverages." NCL asked that the "Alcohol Facts" panel include serving size, the number of calories per serving, alcohol content information (including the amount of alcohol per serving, the definition of a "standard drink," and the number of standard drinks per container), and ingredient information.
"The nine college students who went to an emergency room for alcohol poisoning after drinking too much of a caffeinated alcoholic beverage earlier this year may not have realized just how much alcohol they were consuming," added Greenberg. "Maybe if the standard drinks per container had been required to appear on the labels, they wouldn't have made that mistake."
TTB's inaction on Alcohol Facts labeling is also interfering with other important public health objectives. A new law requires nutrition labeling of foods and beverages served in chain restaurants and bars, including alcoholic beverages, but there is no approved method for measuring certain nutrients in alcohol and TTB has provided the industry with no guidance. If the Alcohol Facts panel were required, restaurants and bars could simply use the information on the product label.
The lack of calorie and alcohol information on beer, wine, and spirits labels is also an obstacle to application of the Dietary Guidelines for Americans. The Departments of Agriculture and Health and Human Services will soon issue the 2010 Dietary Guidelines, but, without calorie and alcohol information on product labels, consumers still will not be able to follow its recommendations on weight control and alcohol consumption.
"Label reform for alcoholic beverages is a no brainer," according to Greenberg. "What is TTB waiting for?"
-----
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Wednesday, December 15, 2010
FDA says Tessalon liquid cough capsules pose risk for young children
The U.S. Food and Drug Administration is warning that accidental ingestion of Tessalon (benzonatate) by children younger than 10 years can result in serious side effects or death.
Tessalon, approved by the FDA to treat symptomatic relief of cough in patients older than 10, may attract younger children because of the drug’s candy-like appearance – a round, liquid-filled gelatin capsule. The safety and effectiveness of benzonatate in children younger than 10 years has not been established.
“Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, R.Ph., director of FDA’s Division of Medication Error Prevention and Analysis. “The FDA encourages health care professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose.”
A review of the FDA’s Adverse Event Reporting System database from 1982 through May 2010 identified seven cases of accidental ingestion associated with benzonatate in children younger than 10. Five of the cases resulted in death in children ages 2 years and younger. Overdose with benzonatate in children younger than 2 years has been reported following accidental ingestion of only one or two benzonatate capsules.
Common adverse events reported in the overdose cases included cardiac arrest, coma, and convulsion. Signs and symptoms of overdose can occur within 15-20 minutes of ingestion. Some of the deaths reported in children have been within hours of the accidental ingestion.
The FDA is also adding a new Warning and Precaution section to the benzonatate drug label to warn health care professionals about accidental ingestion resulting in overdose and death in children younger than 10.
Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of benzonatate to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.
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Tessalon, approved by the FDA to treat symptomatic relief of cough in patients older than 10, may attract younger children because of the drug’s candy-like appearance – a round, liquid-filled gelatin capsule. The safety and effectiveness of benzonatate in children younger than 10 years has not been established.
“Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, R.Ph., director of FDA’s Division of Medication Error Prevention and Analysis. “The FDA encourages health care professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose.”
A review of the FDA’s Adverse Event Reporting System database from 1982 through May 2010 identified seven cases of accidental ingestion associated with benzonatate in children younger than 10. Five of the cases resulted in death in children ages 2 years and younger. Overdose with benzonatate in children younger than 2 years has been reported following accidental ingestion of only one or two benzonatate capsules.
Common adverse events reported in the overdose cases included cardiac arrest, coma, and convulsion. Signs and symptoms of overdose can occur within 15-20 minutes of ingestion. Some of the deaths reported in children have been within hours of the accidental ingestion.
The FDA is also adding a new Warning and Precaution section to the benzonatate drug label to warn health care professionals about accidental ingestion resulting in overdose and death in children younger than 10.
Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of benzonatate to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.
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Thursday, December 09, 2010
Surgeon General's Report Dramatically Demonstrates Immediate Harm From Smoking and Secondhand Smoke
/PRNewswire-/ -- The following is a statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids:
The U.S. Surgeon General's report released today provides dramatic new evidence that smoking and exposure to secondhand smoke cause immediate harm to the human body, triggering physical changes that lead to cancer, heart attacks, lung disease and many other serious illnesses, including damage to the reproductive systems of both men and women.
The report also concludes that design changes to cigarettes, such as filter ventilation, flavoring agents and added chemical ingredients, have over time made them more addictive. Today's cigarettes deliver nicotine more efficiently to the brain, addicting kids more quickly and making it harder for smokers to quit. The tobacco industry's decades-long effort to finely engineer cigarettes, along with its use of deceptive (and now-banned) cigarette descriptions such as "light" and "low-tar," have undermined smoking prevention and cessation efforts, the report says.
Nearly 50 years after the first Surgeon General's report on tobacco was released in 1964, this latest report is a stark reminder of how lethal and addictive smoking truly is, with every cigarette doing you damage. It sends an unmistakable message to elected officials at all levels that reducing smoking is one of the most effective actions we can take to improve the nation's health and prevent some of the most deadly and costly diseases in our society.
The report also sends important messages to America's kids and smokers. If you do not smoke, don't start. If you do smoke, try to quit immediately and get the help you need to succeed. This is true not only for regular smokers, but also for the 22 percent of smokers who do not smoke every day and to those who consider themselves only "social" smokers and may think they are not at risk. This report's message is clear: You are at risk. There is no risk-free level of exposure to tobacco smoke, and you don't have to be a heavy or long-time smoker to develop a smoking-related disease.
The report underscores the importance of actions that we know work to prevent kids from starting to smoke, help smokers quit and protect everyone's right to breathe clean air, free of the hundreds of toxic chemicals in secondhand smoke. Despite progress in making workplaces and public spaces smoke-free, four in ten non-smokers – and more than half of children between 3 and 11 – are still exposed to secondhand smoke, according to the Centers for Disease Control and Prevention. No one should have to breathe secondhand smoke at work or in public places, and parents should ensure that homes, cars and other places frequented by children are smoke-free.
Federal, state and local policymakers must redouble their efforts to implement proven measures that reduce tobacco use and exposure to secondhand smoke.
The federal government must fund and aggressively implement the new tobacco prevention plan that Health and Human Services Secretary Kathleen Sebelius announced last month. The plan includes a national media campaign to prevent kids from smoking and encourage smokers to quit; expanded assistance and health insurance coverage for smokers trying to quit; effective regulation of tobacco products and marketing; and accelerated research to enhance strategies to reduce tobacco use.
The Food and Drug Administration must continue to vigorously exercise its new authority to regulate the manufacture, marketing and sale of tobacco products to keep these harmful products away from our children and reduce their devastating effects on public health.
The states must step up their efforts to reduce tobacco use by increasing tobacco taxes, enacting smoke-free workplace laws and fully funding tobacco prevention and cessation programs at levels recommended by the CDC. Unfortunately, states have slashed funding for tobacco prevention programs by 28 percent in the past three years and now fund such programs at the lowest level since 1999, when they first received funds from the settlement of state lawsuits against the tobacco industry. The states this year (Fiscal Year 2011) will collect $25.3 billion in revenue from the tobacco settlement and tobacco taxes, but will spend only two percent of it — $517.9 million — on programs to prevent kids from smoking and help smokers quit.
The Surgeon General's report details the serious health effects of even brief exposure to tobacco smoke. It concludes that:
* Tobacco smoke contains more than 7,000 chemicals and compounds, including hundreds that are toxic and at least 70 that cause cancer.
* Every exposure to the cancer-causing chemicals in tobacco smoke can damage DNA in a way that leads to cancer.
* Exposure to secondhand smoke has an immediate adverse impact on the cardiovascular system, damaging blood vessels, making blood more likely to clot and increasing risks for heart attack and stroke.
* Smoking makes it harder for women to get pregnant and can cause miscarriage, premature birth and low birth weight. It also harms male fertility.
The Surgeon General's report provides the grim details of how tobacco use kills more than 400,000 Americans each year and costs almost $100 billion in health care expenditures. It underscores the need for political will and urgent action to win the fight against tobacco.
The report, titled "How Tobacco Smoke Causes Disease," can be found at: www.surgeongeneral.gov.
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The U.S. Surgeon General's report released today provides dramatic new evidence that smoking and exposure to secondhand smoke cause immediate harm to the human body, triggering physical changes that lead to cancer, heart attacks, lung disease and many other serious illnesses, including damage to the reproductive systems of both men and women.
The report also concludes that design changes to cigarettes, such as filter ventilation, flavoring agents and added chemical ingredients, have over time made them more addictive. Today's cigarettes deliver nicotine more efficiently to the brain, addicting kids more quickly and making it harder for smokers to quit. The tobacco industry's decades-long effort to finely engineer cigarettes, along with its use of deceptive (and now-banned) cigarette descriptions such as "light" and "low-tar," have undermined smoking prevention and cessation efforts, the report says.
Nearly 50 years after the first Surgeon General's report on tobacco was released in 1964, this latest report is a stark reminder of how lethal and addictive smoking truly is, with every cigarette doing you damage. It sends an unmistakable message to elected officials at all levels that reducing smoking is one of the most effective actions we can take to improve the nation's health and prevent some of the most deadly and costly diseases in our society.
The report also sends important messages to America's kids and smokers. If you do not smoke, don't start. If you do smoke, try to quit immediately and get the help you need to succeed. This is true not only for regular smokers, but also for the 22 percent of smokers who do not smoke every day and to those who consider themselves only "social" smokers and may think they are not at risk. This report's message is clear: You are at risk. There is no risk-free level of exposure to tobacco smoke, and you don't have to be a heavy or long-time smoker to develop a smoking-related disease.
The report underscores the importance of actions that we know work to prevent kids from starting to smoke, help smokers quit and protect everyone's right to breathe clean air, free of the hundreds of toxic chemicals in secondhand smoke. Despite progress in making workplaces and public spaces smoke-free, four in ten non-smokers – and more than half of children between 3 and 11 – are still exposed to secondhand smoke, according to the Centers for Disease Control and Prevention. No one should have to breathe secondhand smoke at work or in public places, and parents should ensure that homes, cars and other places frequented by children are smoke-free.
Federal, state and local policymakers must redouble their efforts to implement proven measures that reduce tobacco use and exposure to secondhand smoke.
The federal government must fund and aggressively implement the new tobacco prevention plan that Health and Human Services Secretary Kathleen Sebelius announced last month. The plan includes a national media campaign to prevent kids from smoking and encourage smokers to quit; expanded assistance and health insurance coverage for smokers trying to quit; effective regulation of tobacco products and marketing; and accelerated research to enhance strategies to reduce tobacco use.
The Food and Drug Administration must continue to vigorously exercise its new authority to regulate the manufacture, marketing and sale of tobacco products to keep these harmful products away from our children and reduce their devastating effects on public health.
The states must step up their efforts to reduce tobacco use by increasing tobacco taxes, enacting smoke-free workplace laws and fully funding tobacco prevention and cessation programs at levels recommended by the CDC. Unfortunately, states have slashed funding for tobacco prevention programs by 28 percent in the past three years and now fund such programs at the lowest level since 1999, when they first received funds from the settlement of state lawsuits against the tobacco industry. The states this year (Fiscal Year 2011) will collect $25.3 billion in revenue from the tobacco settlement and tobacco taxes, but will spend only two percent of it — $517.9 million — on programs to prevent kids from smoking and help smokers quit.
The Surgeon General's report details the serious health effects of even brief exposure to tobacco smoke. It concludes that:
* Tobacco smoke contains more than 7,000 chemicals and compounds, including hundreds that are toxic and at least 70 that cause cancer.
* Every exposure to the cancer-causing chemicals in tobacco smoke can damage DNA in a way that leads to cancer.
* Exposure to secondhand smoke has an immediate adverse impact on the cardiovascular system, damaging blood vessels, making blood more likely to clot and increasing risks for heart attack and stroke.
* Smoking makes it harder for women to get pregnant and can cause miscarriage, premature birth and low birth weight. It also harms male fertility.
The Surgeon General's report provides the grim details of how tobacco use kills more than 400,000 Americans each year and costs almost $100 billion in health care expenditures. It underscores the need for political will and urgent action to win the fight against tobacco.
The report, titled "How Tobacco Smoke Causes Disease," can be found at: www.surgeongeneral.gov.
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Saturday, November 20, 2010
Darvon and Darvocet: Risks Outweigh the Benefits
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Friday, November 19, 2010
Some "Lead-Free" Pottery Can Still Taint Food
/PRNewswire/ -- Colorful pottery may look nice on the dining room table. But beware: it can cause serious harm if it can contaminate food placed in it with lead.
The Food and Drug Administration (FDA) says it has confirmed reports that traditional ceramic pottery made by several manufacturers in Mexico -- and labeled "lead free" -- in fact contains lead.
Learn about this pottery, and steps you can take to detect it, at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm233531.htm.
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The Food and Drug Administration (FDA) says it has confirmed reports that traditional ceramic pottery made by several manufacturers in Mexico -- and labeled "lead free" -- in fact contains lead.
Learn about this pottery, and steps you can take to detect it, at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm233531.htm.
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Beware of the Break Up Email
What fun! Today, I received a delightful email which immediately went into the trash. It appears the writer of the email worded it in a decidedly hostile manner.
What was so fun about the email was it was allegedly addressed to the young female who was his, er, partner. Then why was the email addressed to so many recipients?
In the email, the writer has promised to upload any and all acts online so the world can enjoy their alleged antics. Wow. If so many recipients have been so intimately involved with the writer of the email, then he was one busy character. No wonder he had to send it to any mailbox he could. He couldn't remember their names!
Scam? I think so. Trash? I know so.
Beware of any email that trashes the alleged recipient. You don't want to be a victim of malware.
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What was so fun about the email was it was allegedly addressed to the young female who was his, er, partner. Then why was the email addressed to so many recipients?
In the email, the writer has promised to upload any and all acts online so the world can enjoy their alleged antics. Wow. If so many recipients have been so intimately involved with the writer of the email, then he was one busy character. No wonder he had to send it to any mailbox he could. He couldn't remember their names!
Scam? I think so. Trash? I know so.
Beware of any email that trashes the alleged recipient. You don't want to be a victim of malware.
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Thursday, November 18, 2010
Violent Pornography Linked to Sexually Aggressive Behavior in Children and Adolescents
/PRNewswire/ -- Viewing violent x-rated material may contribute to sexually aggressive behavior among 10-17 year olds. X-rated material without violent content does not appear to have the same impact, finds a new study conducted by Internet Solutions for Kids and funded by the Centers for Disease Control and Prevention. Published in Aggressive Behavior, the study is expected to be highly influential. "Because of the obvious ethical problems of purposefully exposing kids to pornography," Dr. Michele Ybarra, the primary author of the study, explains, "little was known before about how viewing x-rated material may be related to sexual aggression in children. We asked kids whether they had looked at x-rated material before, and then looked to see if the kids who said 'yes' were more likely to also say that they were sexually aggressive."
The study finds that youth who look at violent x-rated material are six times more likely to report forcing someone to do something sexual online or in-person versus kids not exposed to x-rated material. Watching violent pornography does not always lead to sexual aggression and not all sexual aggressors have been exposed to pornography, Ybarra cautions; nor does the study prove that violent x-rated material causes sexual aggression.
Exposure to Internet pornography is relatively common. Findings from the Youth Internet Safety Survey – 2 indicate that 15% of 12-17 year olds have purposefully looked at x-rated material online. Data from the Pew Internet and American Life Project suggest that 70% of 15-17 year-old Internet users accidentally view pornography "very" or "somewhat" often. Nevertheless, Ybarra's study also finds that the Internet is not the most common source of x-rated material – even violent x-rated material. Fourteen percent looked at x-rated material in movies, 12% in magazines, and 11% online.
"There's an assumption out there that the Internet has somehow increased kids' exposures to deviant content. Our data don't support this. We're learning that just because content that we find disturbing is accessible online, doesn't mean kids will seek it out," Ybarra explains. She agrees that blocking and filtering software will likely prevent exposure to violent x-rated material online. "But, these things won't do anything to prevent exposure through magazines and movies. That's why it's important to talk to your kids also."
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The study finds that youth who look at violent x-rated material are six times more likely to report forcing someone to do something sexual online or in-person versus kids not exposed to x-rated material. Watching violent pornography does not always lead to sexual aggression and not all sexual aggressors have been exposed to pornography, Ybarra cautions; nor does the study prove that violent x-rated material causes sexual aggression.
Exposure to Internet pornography is relatively common. Findings from the Youth Internet Safety Survey – 2 indicate that 15% of 12-17 year olds have purposefully looked at x-rated material online. Data from the Pew Internet and American Life Project suggest that 70% of 15-17 year-old Internet users accidentally view pornography "very" or "somewhat" often. Nevertheless, Ybarra's study also finds that the Internet is not the most common source of x-rated material – even violent x-rated material. Fourteen percent looked at x-rated material in movies, 12% in magazines, and 11% online.
"There's an assumption out there that the Internet has somehow increased kids' exposures to deviant content. Our data don't support this. We're learning that just because content that we find disturbing is accessible online, doesn't mean kids will seek it out," Ybarra explains. She agrees that blocking and filtering software will likely prevent exposure to violent x-rated material online. "But, these things won't do anything to prevent exposure through magazines and movies. That's why it's important to talk to your kids also."
-----
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Wednesday, November 17, 2010
FDA Warning Letters issued to four makers of caffeinated alcoholic beverages
The U.S. Food and Drug Administration today warned four companies that the caffeine added to their malt alcoholic beverages is an “unsafe food additive” and said that further action, including seizure of their products, is possible under federal law.
The companies receiving Warning Letters and their products are:
• Charge Beverages Corp.: Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked
• New Century Brewing Co., LLC: Moonshot
• Phusion Projects, LLC (doing business as Drink Four Brewing Co.): Four Loko
• United Brands Company Inc.: Joose and Max
FDA’s action follows a scientific review by the Agency. FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers. FDA also performed its own independent laboratory analysis of these products.
“FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner. “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”
Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication. The FDA said peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and life-threatening situations.
The agency said the products named in the Warning Letters are being marketed in violation of the Federal Food, Drug, and Cosmetic Act (the FFDCA). Each Warning Letter requests that the recipient inform the FDA in writing within 15 days of the specific steps that will be taken to remedy the violation and prevent its recurrence. If a company does not believe its products are in violation of the FFDCA, it may present its reasoning and any supporting information as well.
If the FDA believes that the violation continues to exist, the agency may pursue an enforcement action that could include seizure of the products or an injunction to prevent the firm from continuing to produce the product until the violation has been corrected.
FDA’s action today follows a November 2009 request to manufacturers to provide information on the safety of adding caffeine to their products.
FDA is aware that on November 16, Phusion Projects, LLC, the maker of Four Loko, announced its intention to remove caffeine and other stimulants from its drinks. FDA views this announcement as a positive step. FDA has not yet heard officially from the company about this announcement, including how quickly it will remove present product from circulation and how quickly it will reformulate its product. FDA intends to work with Phusion Projects, LLC and the other manufacturers to assure their products meet safety standards.
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The companies receiving Warning Letters and their products are:
• Charge Beverages Corp.: Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked
• New Century Brewing Co., LLC: Moonshot
• Phusion Projects, LLC (doing business as Drink Four Brewing Co.): Four Loko
• United Brands Company Inc.: Joose and Max
FDA’s action follows a scientific review by the Agency. FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers. FDA also performed its own independent laboratory analysis of these products.
“FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner. “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”
Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication. The FDA said peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and life-threatening situations.
The agency said the products named in the Warning Letters are being marketed in violation of the Federal Food, Drug, and Cosmetic Act (the FFDCA). Each Warning Letter requests that the recipient inform the FDA in writing within 15 days of the specific steps that will be taken to remedy the violation and prevent its recurrence. If a company does not believe its products are in violation of the FFDCA, it may present its reasoning and any supporting information as well.
If the FDA believes that the violation continues to exist, the agency may pursue an enforcement action that could include seizure of the products or an injunction to prevent the firm from continuing to produce the product until the violation has been corrected.
FDA’s action today follows a November 2009 request to manufacturers to provide information on the safety of adding caffeine to their products.
FDA is aware that on November 16, Phusion Projects, LLC, the maker of Four Loko, announced its intention to remove caffeine and other stimulants from its drinks. FDA views this announcement as a positive step. FDA has not yet heard officially from the company about this announcement, including how quickly it will remove present product from circulation and how quickly it will reformulate its product. FDA intends to work with Phusion Projects, LLC and the other manufacturers to assure their products meet safety standards.
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New Report: States Slash Funding for Tobacco Prevention Programs to Lowest Level Since Tobacco Settlement
/PRNewswire-/ -- The states have slashed funding for programs to reduce tobacco use to the lowest level since 1999, when they first received tobacco settlement funds, according to a report released today by a coalition of public health organizations.
The states this year (Fiscal Year 2011) will collect $25.3 billion in revenue from the tobacco settlement and tobacco taxes, but will spend only two percent of it – $517.9 million – on programs to prevent kids from smoking and help smokers quit. The states have cut funding for such programs by nine percent ($51.4 million) in the past year and by 28 percent ($199.3 million) in the past three years.
With the U.S. adult smoking rate stalled at 20.6 percent after decades of decline, the report warns that continued progress against tobacco use – the nation's number one cause of preventable death – is at risk unless states increase funding for tobacco prevention and cessation programs. The report also calls on states to increase tobacco taxes and, for states that have yet to do so, to enact strong smoke-free laws that apply to all workplaces, restaurants and bars.
The report further calls on the federal government to robustly fund and implement the national tobacco prevention strategy unveiled last week by the U.S. Department of Health and Human Services, including launching a national media campaign to discourage kids from smoking and encourage smokers to quit.
The report, titled "A Broken Promise to Our Children: The 1998 State Tobacco Settlement 12 Years Later," was released by the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society Cancer Action Network, American Lung Association and Robert Wood Johnson Foundation. These organizations have issued annual reports assessing whether the states have kept their promise to use funds from the state tobacco settlements – estimated to total $246 billion over the first 25 years – to fight tobacco use.
"We know how to win the fight against tobacco, but we will not win it unless elected officials at all levels step up efforts to implement proven solutions," said Matthew L. Myers, President of the Campaign for Tobacco-Free Kids. "Despite their budgetary challenges, the states are collecting huge sums from the tobacco industry and should be spending more of it to prevent kids from smoking and help smokers quit. Tobacco prevention is a smart investment for the states that saves lives and saves money by reducing tobacco-related health care costs."
Other findings of this year's report include:
* Most states are falling far short of meeting recommended funding levels for tobacco prevention programs set by the U.S. Centers for Disease Control and Prevention (CDC). The $517.9 million the states have budgeted amounts to just 14 percent of the $3.7 billion the CDC recommends for all the states combined.
* Counting both state funds and federal grants, only two states – Alaska and North Dakota – currently fund tobacco prevention programs at CDC-recommended levels. Only five other states provide even half the recommended funding, while 33 states and DC provide less than a quarter. Three states – Nevada, New Hampshire and Ohio – provide zero state funds for tobacco prevention this year.
* Tobacco companies spend nearly $25 to market tobacco products for every $1 the states spend to fight tobacco use. According to the latest data from the Federal Trade Commission, tobacco companies spend $12.8 billion a year on marketing.
* Federal grants, most of them temporary, have helped to cushion the impact of funding cuts in some states. In the past year, the federal government has provided $261.6 million in state and community grants specifically dedicated to reducing tobacco use (the grants are spread over three fiscal years, so not all the money will be spent in fiscal 2011).
The report comes as recent surveys have found that smoking declines in the United States have slowed and even stalled. The CDC recently reported that the adult smoking rate in 2009 was 20.6 percent – essentially unchanged since 2004 when 20.9 percent smoked. While smoking among high school students has declined by 46 percent from a high of 36.4 percent in 1997, 19.5 percent still smoke.
"We know that much of what helps us live longer, healthier lives happens outside the doctor's office," said Risa Lavizzo-Mourey, M.D., M.B.A., President and CEO of the Robert Wood Johnson Foundation. "With progress on smoking rates stalled, it's more important than ever for states to focus on community prevention programs and policies that work – like smoke-free restaurants and workplaces and adequate funding to prevent kids from starting and to help smokers quit."
"For every step forward in curbing tobacco use among Americans, many states have taken two steps backwards," said American Heart Association CEO Nancy Brown. "The public health community is appalled at the lack of commitment among a vast majority of states to adequately fund comprehensive tobacco prevention and cessation programs with the settlement dollars. As tobacco companies devise new tactics to increase smoking rates among children and adults, it's more important than ever to protect Americans from the dangers of tobacco use and give smokers the necessary tools to reduce their risk for heart disease, stroke and other smoking-related illnesses."
"Fully funded tobacco prevention and cessation programs stop addiction before it starts and improve the health of our nation's communities," said John R. Seffrin, PhD, chief executive officer of the American Cancer Society Cancer Action Network (ACS CAN), the advocacy affiliate of the American Cancer Society. "Given the record low amount that states are allocating to these important programs, they simply must do a better job at properly allocating funding that helps reduce tobacco use and protects the health of children, 4,100 of whom try their first cigarette every day."
"States have a responsibility to prevent people from starting to smoke and to ensure that all smokers have easy access to cessation treatments and services as the human and financial toll of tobacco continues to rise," said Charles D. Connor, American Lung Association President and CEO. "Preventing kids from smoking and helping smokers quit saves lives and money."
Tobacco use and exposure to secondhand smoke kill more than 400,000 people in the United States each year and cost the nation more than $96 billion in health care bills. Every day, another 1,000 kids become regular smokers – one-third of them will die prematurely as a result.
-----
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The states this year (Fiscal Year 2011) will collect $25.3 billion in revenue from the tobacco settlement and tobacco taxes, but will spend only two percent of it – $517.9 million – on programs to prevent kids from smoking and help smokers quit. The states have cut funding for such programs by nine percent ($51.4 million) in the past year and by 28 percent ($199.3 million) in the past three years.
With the U.S. adult smoking rate stalled at 20.6 percent after decades of decline, the report warns that continued progress against tobacco use – the nation's number one cause of preventable death – is at risk unless states increase funding for tobacco prevention and cessation programs. The report also calls on states to increase tobacco taxes and, for states that have yet to do so, to enact strong smoke-free laws that apply to all workplaces, restaurants and bars.
The report further calls on the federal government to robustly fund and implement the national tobacco prevention strategy unveiled last week by the U.S. Department of Health and Human Services, including launching a national media campaign to discourage kids from smoking and encourage smokers to quit.
The report, titled "A Broken Promise to Our Children: The 1998 State Tobacco Settlement 12 Years Later," was released by the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society Cancer Action Network, American Lung Association and Robert Wood Johnson Foundation. These organizations have issued annual reports assessing whether the states have kept their promise to use funds from the state tobacco settlements – estimated to total $246 billion over the first 25 years – to fight tobacco use.
"We know how to win the fight against tobacco, but we will not win it unless elected officials at all levels step up efforts to implement proven solutions," said Matthew L. Myers, President of the Campaign for Tobacco-Free Kids. "Despite their budgetary challenges, the states are collecting huge sums from the tobacco industry and should be spending more of it to prevent kids from smoking and help smokers quit. Tobacco prevention is a smart investment for the states that saves lives and saves money by reducing tobacco-related health care costs."
Other findings of this year's report include:
* Most states are falling far short of meeting recommended funding levels for tobacco prevention programs set by the U.S. Centers for Disease Control and Prevention (CDC). The $517.9 million the states have budgeted amounts to just 14 percent of the $3.7 billion the CDC recommends for all the states combined.
* Counting both state funds and federal grants, only two states – Alaska and North Dakota – currently fund tobacco prevention programs at CDC-recommended levels. Only five other states provide even half the recommended funding, while 33 states and DC provide less than a quarter. Three states – Nevada, New Hampshire and Ohio – provide zero state funds for tobacco prevention this year.
* Tobacco companies spend nearly $25 to market tobacco products for every $1 the states spend to fight tobacco use. According to the latest data from the Federal Trade Commission, tobacco companies spend $12.8 billion a year on marketing.
* Federal grants, most of them temporary, have helped to cushion the impact of funding cuts in some states. In the past year, the federal government has provided $261.6 million in state and community grants specifically dedicated to reducing tobacco use (the grants are spread over three fiscal years, so not all the money will be spent in fiscal 2011).
The report comes as recent surveys have found that smoking declines in the United States have slowed and even stalled. The CDC recently reported that the adult smoking rate in 2009 was 20.6 percent – essentially unchanged since 2004 when 20.9 percent smoked. While smoking among high school students has declined by 46 percent from a high of 36.4 percent in 1997, 19.5 percent still smoke.
"We know that much of what helps us live longer, healthier lives happens outside the doctor's office," said Risa Lavizzo-Mourey, M.D., M.B.A., President and CEO of the Robert Wood Johnson Foundation. "With progress on smoking rates stalled, it's more important than ever for states to focus on community prevention programs and policies that work – like smoke-free restaurants and workplaces and adequate funding to prevent kids from starting and to help smokers quit."
"For every step forward in curbing tobacco use among Americans, many states have taken two steps backwards," said American Heart Association CEO Nancy Brown. "The public health community is appalled at the lack of commitment among a vast majority of states to adequately fund comprehensive tobacco prevention and cessation programs with the settlement dollars. As tobacco companies devise new tactics to increase smoking rates among children and adults, it's more important than ever to protect Americans from the dangers of tobacco use and give smokers the necessary tools to reduce their risk for heart disease, stroke and other smoking-related illnesses."
"Fully funded tobacco prevention and cessation programs stop addiction before it starts and improve the health of our nation's communities," said John R. Seffrin, PhD, chief executive officer of the American Cancer Society Cancer Action Network (ACS CAN), the advocacy affiliate of the American Cancer Society. "Given the record low amount that states are allocating to these important programs, they simply must do a better job at properly allocating funding that helps reduce tobacco use and protects the health of children, 4,100 of whom try their first cigarette every day."
"States have a responsibility to prevent people from starting to smoke and to ensure that all smokers have easy access to cessation treatments and services as the human and financial toll of tobacco continues to rise," said Charles D. Connor, American Lung Association President and CEO. "Preventing kids from smoking and helping smokers quit saves lives and money."
Tobacco use and exposure to secondhand smoke kill more than 400,000 people in the United States each year and cost the nation more than $96 billion in health care bills. Every day, another 1,000 kids become regular smokers – one-third of them will die prematurely as a result.
-----
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Watchdog Calls for State Bans on Alcoholic Energy Drinks
/PRNewswire/ -- While applauding expected actions by the Food and Drug Administration and Federal Trade Commission against dangerous alcoholic energy drinks, Marin Institute, the alcohol industry watchdog, called for strong state action as well.
In the wake of increased media attention to the grave risks of combining caffeine with high-alcohol content, states have taking swift stands. In the past 2 weeks alone, four states – Michigan, Oklahoma, Washington, and New York— have shown leadership by banning the products or suspending their sale, while many more states are planning similar actions.
"State-level product bans will continue to be necessary to get the products off of store shelves," explained Michele Simon, Marin Institute's research and policy director and co-author of the 2007 report. "States are the primary regulators of alcoholic beverages and have full authority to ban alcoholic energy drinks whether by regulatory or legislative action, or through attorney general enforcement," Simon added.
Marin Institute first sounded the alarm about alcoholic energy drinks in 2007, with its groundbreaking report, Alcohol, Energy Drinks, and Youth: A Dangerous Mix. The report describes both the health risks and how companies market these products to youth.
"We are thrilled that the federal government is taking action," said Simon. "We have maintained all along that these products contain illegal additives in the form of caffeine and other stimulants and that they are being deceptively marketed to youth."
For the past several years, Marin Institute has called on companies to stop making these products, for states to ban or restrict them, and for the federal government to act as well. Most recently, Marin Institute directed more than 1,200 emails from around the country calling on FDA to ban alcoholic energy drinks. In 2010, Marin Institute backed legislation in Washington State, California, and New York to ban the tainted products.
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In the wake of increased media attention to the grave risks of combining caffeine with high-alcohol content, states have taking swift stands. In the past 2 weeks alone, four states – Michigan, Oklahoma, Washington, and New York— have shown leadership by banning the products or suspending their sale, while many more states are planning similar actions.
"State-level product bans will continue to be necessary to get the products off of store shelves," explained Michele Simon, Marin Institute's research and policy director and co-author of the 2007 report. "States are the primary regulators of alcoholic beverages and have full authority to ban alcoholic energy drinks whether by regulatory or legislative action, or through attorney general enforcement," Simon added.
Marin Institute first sounded the alarm about alcoholic energy drinks in 2007, with its groundbreaking report, Alcohol, Energy Drinks, and Youth: A Dangerous Mix. The report describes both the health risks and how companies market these products to youth.
"We are thrilled that the federal government is taking action," said Simon. "We have maintained all along that these products contain illegal additives in the form of caffeine and other stimulants and that they are being deceptively marketed to youth."
For the past several years, Marin Institute has called on companies to stop making these products, for states to ban or restrict them, and for the federal government to act as well. Most recently, Marin Institute directed more than 1,200 emails from around the country calling on FDA to ban alcoholic energy drinks. In 2010, Marin Institute backed legislation in Washington State, California, and New York to ban the tainted products.
-----
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Wednesday, October 20, 2010
Uranium threatens some Georgia drinking water
Uranium is a naturally occurring radioactive element found in some rocks and groundwater. It can make its way into drinking water, where it can be harmful to health. Some parts of Georgia could have problems with it.
Safe drinking water should contain less than 30 parts per billion of uranium. A small number of wells located in Georgia’s piedmont region exceed the Environmental Protection Agency’s standard uranium amount.
“The potential problem areas are supplied by wells deeper than 100 feet on granite bedrock,” said David Kissel, director of the University of Georgia Agricultural and Environmental Services Laboratories. “Levels of uranium above 30 ppb have not been found in shallow wells or surface water.”
Water that comes from a public system is routinely tested to ensure uranium levels are safe. People consuming water from a private well, cistern or spring are responsible for their own testing and are encouraged to monitor contamination. Water samples can be submitted for testing through a local UGA Cooperative Extension office.
Studies suggest that water containing levels of uranium higher than the standard may hurt kidney function. Health concerns related to uranium should be taken to a local physician.
Although drinking high levels or uranium can be harmful, skin contact is not harmful according to the Agency for Toxic Substances and Disease Registry. Water high in uranium is OK to use for bathing, washing clothes or gardening.
If a well has high levels of uranium, Kissel said, its water should be treated through filtration systems. Affordable, at-home options such as point-of-use reverse osmosis, or RO, systems are available from many manufacturers.
These systems are placed on a faucet and produce 5 gallons to 20 gallons of safe drinking water per day.
“RO systems remove a high percentage of ions that are in the water,” Kissel said. “Uranium is dissolved in the water, and the RO system pushes the water through a semi-permeable membrane with high pressure to filter the uranium out of the water.”
After an at-home treatment system is installed, the water should be tested again to ensure the filtration system is working properly and the uranium level is below the standard.
People who live in areas that contain water with high concentrations of uranium should also be concerned with elevated levels of radon in their homes.
“Radon is a decomposition product of uranium,” Kissel said “The air filters in through the basement. It is recommended that well owners with elevated uranium levels also test their homes for radon gas.”
Radon test kits are available at county UGA Extension offices.
More information on water contamination or water treatment systems can be found at the National Sanitation Foundation at nsf.org/certified/dwtu or Water Quality Association at www.wqa.org/sitelogic.cfm?id=1165§ion=3.
By Sarah Lewis
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Safe drinking water should contain less than 30 parts per billion of uranium. A small number of wells located in Georgia’s piedmont region exceed the Environmental Protection Agency’s standard uranium amount.
“The potential problem areas are supplied by wells deeper than 100 feet on granite bedrock,” said David Kissel, director of the University of Georgia Agricultural and Environmental Services Laboratories. “Levels of uranium above 30 ppb have not been found in shallow wells or surface water.”
Water that comes from a public system is routinely tested to ensure uranium levels are safe. People consuming water from a private well, cistern or spring are responsible for their own testing and are encouraged to monitor contamination. Water samples can be submitted for testing through a local UGA Cooperative Extension office.
Studies suggest that water containing levels of uranium higher than the standard may hurt kidney function. Health concerns related to uranium should be taken to a local physician.
Although drinking high levels or uranium can be harmful, skin contact is not harmful according to the Agency for Toxic Substances and Disease Registry. Water high in uranium is OK to use for bathing, washing clothes or gardening.
If a well has high levels of uranium, Kissel said, its water should be treated through filtration systems. Affordable, at-home options such as point-of-use reverse osmosis, or RO, systems are available from many manufacturers.
These systems are placed on a faucet and produce 5 gallons to 20 gallons of safe drinking water per day.
“RO systems remove a high percentage of ions that are in the water,” Kissel said. “Uranium is dissolved in the water, and the RO system pushes the water through a semi-permeable membrane with high pressure to filter the uranium out of the water.”
After an at-home treatment system is installed, the water should be tested again to ensure the filtration system is working properly and the uranium level is below the standard.
People who live in areas that contain water with high concentrations of uranium should also be concerned with elevated levels of radon in their homes.
“Radon is a decomposition product of uranium,” Kissel said “The air filters in through the basement. It is recommended that well owners with elevated uranium levels also test their homes for radon gas.”
Radon test kits are available at county UGA Extension offices.
More information on water contamination or water treatment systems can be found at the National Sanitation Foundation at nsf.org/certified/dwtu or Water Quality Association at www.wqa.org/sitelogic.cfm?id=1165§ion=3.
By Sarah Lewis
-----
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Friday, October 08, 2010
FDA: Potentially harmful stimulant found in Slimming Beauty capsules
The U.S. Food and Drug Administration today advised consumers who have Slimming Beauty Bitter Orange Slimming Capsules not to use the product. FDA warns that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug which is a stimulant. Sibutramine is not listed on the product label and could harm consumers, especially those with cardiovascular conditions.
FDA lab tests reveal that the product contains excessive amounts of sibutramine that may be dangerous to people who have a history of cardiovascular disease, because it can lead to elevated blood pressure, stroke, and heart attack.
Consumers who are otherwise healthy and who take the amount of sibutramine found in Slimming Beauty capsules can experience anxiety, nausea, heart palpitations, a racing heart, insomnia, and elevated blood pressure. Sibutramine also may interact with other medications and can cause serious side effects.
Sibutramine is a powerful stimulant that should not be used without a prescription due to the safety risks associated with it.
Slimming Beauty is being sold over the Internet by Beautiful Health Inc., formerly LL Health and Beauty. Slimming Beauty sample packets also have been distributed by individuals at community events. The product and the sample packets are falsely labeled as “100% Herbal.” The sample packet label is misleading because it indicates that it is a natural vitamin and calcium capsule for use in children as young as 2 years old.
The FDA has determined that Slimming Beauty sample packets were distributed at the 40th Annual Mexican Independence Day Parade in Chicago, on Sept. 12, 2010. The agency is aware of several reports of serious side effects from the use of this product including elevated blood pressure, headaches, vomiting, and insomnia.
Consumers and health care professionals are encouraged to report adverse events related to the use of Slimming Beauty capsules to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm or by phone at 800-FDA-1088 (800-332-1088).
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FDA lab tests reveal that the product contains excessive amounts of sibutramine that may be dangerous to people who have a history of cardiovascular disease, because it can lead to elevated blood pressure, stroke, and heart attack.
Consumers who are otherwise healthy and who take the amount of sibutramine found in Slimming Beauty capsules can experience anxiety, nausea, heart palpitations, a racing heart, insomnia, and elevated blood pressure. Sibutramine also may interact with other medications and can cause serious side effects.
Sibutramine is a powerful stimulant that should not be used without a prescription due to the safety risks associated with it.
Slimming Beauty is being sold over the Internet by Beautiful Health Inc., formerly LL Health and Beauty. Slimming Beauty sample packets also have been distributed by individuals at community events. The product and the sample packets are falsely labeled as “100% Herbal.” The sample packet label is misleading because it indicates that it is a natural vitamin and calcium capsule for use in children as young as 2 years old.
The FDA has determined that Slimming Beauty sample packets were distributed at the 40th Annual Mexican Independence Day Parade in Chicago, on Sept. 12, 2010. The agency is aware of several reports of serious side effects from the use of this product including elevated blood pressure, headaches, vomiting, and insomnia.
Consumers and health care professionals are encouraged to report adverse events related to the use of Slimming Beauty capsules to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm or by phone at 800-FDA-1088 (800-332-1088).
-----
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Tuesday, September 28, 2010
Judicial Watch Uncovers FDA Records Detailing 16 New Deaths Tied to Gardasil
/Standard Newswire/ -- Judicial Watch, the public interest group that investigates and prosecutes government corruption, announced today that it has received new documents from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act (FOIA), detailing reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. The adverse reactions include 16 new deaths (including four suicides) between May 2009 and September 2010. The FDA also produced 789 "serious" reports, with 213 cases resulting in permanent disability and 25 resulting in a diagnosis of Guillian Barre Syndrome.
Adverse report excerpts include:
* A nineteen year old girl with no medical history except occasional cases bronchitis received Gardasil and in 53 days, had "Headache, Nausea, dizziness, chilling, tiredness, shortness of breath, complained of chest plain, severe cramps." She experienced an Acute Cardiac Arrhythmia. Attempts to resuscitate her resulted in a sternal fracture, but were unsuccessful and the patient died. -- V. 356938
* A thirteen year old girl was vaccinated on July 17th, 2009. Ten days later, she developed a fever and was treated. However, "the patient did not recover and was admitted to the hospital on [August 8th]...She developed dyspnoea and went into a coma...she expired [that day] at around 9:00 pm. The cause of death was determined as 'death due to viral fever.' ... This event occurred after 23 days of receiving first dose of Gardasil. -- V. 380081
* Thirteen days after vaccination, a ten year old girl developed "progressive loss of strength in lower and upper extremities almost totally...Nerve conduction studies [showed Guillain Barre Syndrome]." Case was "considered to be immediately life-threatening." -- V. 339375
* One mother of a 13-year old girl who died 37 days after receiving the vaccination noted in a report: "I first declined getting her the vaccination but her doctor ensured me that it was safe..." After her daughter complained of a severe headache, no feeling in her foot and a tingling feeling in her leg, a doctor's appointment was set for October 23, 2009. "My daughter never made it to Oct[ober] 23rd, which is also her birthday," the mother noted. "She passed on Oct[ober] 17th, I found her cold unresponsive in her room at 7am...."
"To say Gardasil has a suspect safety record is a big understatement. These reports are troubling and show that the FDA and other public health authorities may be asleep at the switch," said Judicial Watch President Tom Fitton. "In the meantime, the public relations push for Gardasil by Merck and politicians on Capitol Hill continues. No one should require this vaccine for young children."
In 2008, Judicial Watch launched a comprehensive investigation of Gardasil's safety record. All previous FDA documents uncovered by Judicial Watch, as well as a Judicial Watch special report, entitled "Examining the FDA's HPV Vaccine Records: Detailing the Approval Process, Side-Effects, Safety Concerns & Marketing Practices of a Large Scale Health Experiment," are available at
www.JudicialWatch.org (http://r20.rs6.net/tn.jsp?llr=hl94yxbab&et=1103726832989&s=13633&e=0019k-0tTevIIcuiGvoaAfx-_dDjhrytmKNsMXSa7cx1qOpHEE38bsioz_9OSnd-aZhrS_agrrYNSLxUqcZwuD57S3sJcHV_V_w04pJv06yfKf3xNcIuwQ7Dw==).
-----
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Adverse report excerpts include:
* A nineteen year old girl with no medical history except occasional cases bronchitis received Gardasil and in 53 days, had "Headache, Nausea, dizziness, chilling, tiredness, shortness of breath, complained of chest plain, severe cramps." She experienced an Acute Cardiac Arrhythmia. Attempts to resuscitate her resulted in a sternal fracture, but were unsuccessful and the patient died. -- V. 356938
* A thirteen year old girl was vaccinated on July 17th, 2009. Ten days later, she developed a fever and was treated. However, "the patient did not recover and was admitted to the hospital on [August 8th]...She developed dyspnoea and went into a coma...she expired [that day] at around 9:00 pm. The cause of death was determined as 'death due to viral fever.' ... This event occurred after 23 days of receiving first dose of Gardasil. -- V. 380081
* Thirteen days after vaccination, a ten year old girl developed "progressive loss of strength in lower and upper extremities almost totally...Nerve conduction studies [showed Guillain Barre Syndrome]." Case was "considered to be immediately life-threatening." -- V. 339375
* One mother of a 13-year old girl who died 37 days after receiving the vaccination noted in a report: "I first declined getting her the vaccination but her doctor ensured me that it was safe..." After her daughter complained of a severe headache, no feeling in her foot and a tingling feeling in her leg, a doctor's appointment was set for October 23, 2009. "My daughter never made it to Oct[ober] 23rd, which is also her birthday," the mother noted. "She passed on Oct[ober] 17th, I found her cold unresponsive in her room at 7am...."
"To say Gardasil has a suspect safety record is a big understatement. These reports are troubling and show that the FDA and other public health authorities may be asleep at the switch," said Judicial Watch President Tom Fitton. "In the meantime, the public relations push for Gardasil by Merck and politicians on Capitol Hill continues. No one should require this vaccine for young children."
In 2008, Judicial Watch launched a comprehensive investigation of Gardasil's safety record. All previous FDA documents uncovered by Judicial Watch, as well as a Judicial Watch special report, entitled "Examining the FDA's HPV Vaccine Records: Detailing the Approval Process, Side-Effects, Safety Concerns & Marketing Practices of a Large Scale Health Experiment," are available at
www.JudicialWatch.org (http://r20.rs6.net/tn.jsp?llr=hl94yxbab&et=1103726832989&s=13633&e=0019k-0tTevIIcuiGvoaAfx-_dDjhrytmKNsMXSa7cx1qOpHEE38bsioz_9OSnd-aZhrS_agrrYNSLxUqcZwuD57S3sJcHV_V_w04pJv06yfKf3xNcIuwQ7Dw==).
-----
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Wednesday, September 15, 2010
September Named “Mold Awareness Month”
As National Mold Cases Rise, Local Experts Warn of Increased Health Risks
As documented cases of residential mold contamination and related health problems continue to rise across the nation, the indoor air quality industry is on a crusade to educate homeowners about the serious consequences of mold in the home. (September 5 – October 5) has been deemed Mold Awareness Month by the industry because mold spores that commonly grow in summer humidity are often trapped as people close up homes and foundation vents in the fall. Just a few of these spores can make a family sick.
Consider This:
There are an estimated 10,000 mold-related court cases nationwide
There has been a 300 percent increase in litigation involving mold contamination over the past five years.
The average mold claim costs $35,000 and many exceed $100,000.
“We know to check the batteries in our smoke detectors, to change our air filters, to clean out our gutters and rake our leaves, but no one talks to homeowners about the dangers of household mold,” says Jeff Dudan, CEO and founder of AdvantaClean, a national mold remediation company with a locally owned franchise serving the area. “We’re on a mission to teach homeowners how to limit mold growth and keep their families healthy.”
Fast Facts about Mold:
According to the U.S. EPA, the air inside the average American home can be more than 100 times more polluted than the air outside. New homes usually have poorer air quality than older homes because they’re air tight, so spores can’t escape, providing a perfect breeding ground.
Common household molds cause asthma, sneezing, runny nose, red eyes and skin rashes. Infants and the elderly are most the at risk, because they often have weaker immune systems.
Mold is prevalent in most homes and it’s often difficult to eradicate, but all mold requires moisture to grow, so reducing moisture will reduce mold growth.
Where Mold Grows:
Windowsills, closets, wall paper, flooring, in or around showers, dishwashers, washing machines, and even in the soil of potted plants.
Mold can be caused by slow dripping pipes, condensation, standing water on or under carpets and floor boards, leaky dryer vents, broken shingles and wet insulation.
Preventions and Control:
When water leaks, ACT QUICKLY. If you dry wet materials 24 – 48 hours after a leak or spill, mold will not grow in most cases.
Clean and repair roof gutters and leaky roofs regularly.
Point sprinklers away from the home and siding.
Make sure landscapes slope away from your home’s foundation so water doesn’t collect.
Keep relative indoor humidity low, if possible below 60 percent. Humidity is measured most accurately with a moisture meter, a small $10 - $50 instrument found at most hardware stores.
Use air conditioners and dehumidifiers regularly.
Run the bathroom fan or open the window when showering and up to 10 minutes afterward.
Use exhaust fans or open widows whenever cooking, running the dishwasher or even washing dishes.
Source: AdvantaClean
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As documented cases of residential mold contamination and related health problems continue to rise across the nation, the indoor air quality industry is on a crusade to educate homeowners about the serious consequences of mold in the home. (September 5 – October 5) has been deemed Mold Awareness Month by the industry because mold spores that commonly grow in summer humidity are often trapped as people close up homes and foundation vents in the fall. Just a few of these spores can make a family sick.
Consider This:
There are an estimated 10,000 mold-related court cases nationwide
There has been a 300 percent increase in litigation involving mold contamination over the past five years.
The average mold claim costs $35,000 and many exceed $100,000.
“We know to check the batteries in our smoke detectors, to change our air filters, to clean out our gutters and rake our leaves, but no one talks to homeowners about the dangers of household mold,” says Jeff Dudan, CEO and founder of AdvantaClean, a national mold remediation company with a locally owned franchise serving the area. “We’re on a mission to teach homeowners how to limit mold growth and keep their families healthy.”
Fast Facts about Mold:
According to the U.S. EPA, the air inside the average American home can be more than 100 times more polluted than the air outside. New homes usually have poorer air quality than older homes because they’re air tight, so spores can’t escape, providing a perfect breeding ground.
Common household molds cause asthma, sneezing, runny nose, red eyes and skin rashes. Infants and the elderly are most the at risk, because they often have weaker immune systems.
Mold is prevalent in most homes and it’s often difficult to eradicate, but all mold requires moisture to grow, so reducing moisture will reduce mold growth.
Where Mold Grows:
Windowsills, closets, wall paper, flooring, in or around showers, dishwashers, washing machines, and even in the soil of potted plants.
Mold can be caused by slow dripping pipes, condensation, standing water on or under carpets and floor boards, leaky dryer vents, broken shingles and wet insulation.
Preventions and Control:
When water leaks, ACT QUICKLY. If you dry wet materials 24 – 48 hours after a leak or spill, mold will not grow in most cases.
Clean and repair roof gutters and leaky roofs regularly.
Point sprinklers away from the home and siding.
Make sure landscapes slope away from your home’s foundation so water doesn’t collect.
Keep relative indoor humidity low, if possible below 60 percent. Humidity is measured most accurately with a moisture meter, a small $10 - $50 instrument found at most hardware stores.
Use air conditioners and dehumidifiers regularly.
Run the bathroom fan or open the window when showering and up to 10 minutes afterward.
Use exhaust fans or open widows whenever cooking, running the dishwasher or even washing dishes.
Source: AdvantaClean
-----
Community News You Can Use
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter: @GAFrontPage
Wednesday, September 08, 2010
Low Carb Diet Rich in Animal Fat and Protein Increases Risk of Death
/PRNewswire/ -- Those who adhered to a diet low in carbohydrates but rich in animal-based fats and proteins increased their risk of death - especially by cancer, according to a study published in the Annals of Internal Medicine, led by Simmons College nutrition professor Teresa Fung, Sc. D.
This study is the first of its kind to demonstrate the link between different types of low carbohydrate diets and mortality. It also sought to determine the long-term impact of low carbohydrate diets, which have been promoted as an effective option for weight loss and improving health.
Conversely, the study found that a diet low in carbohydrates but rich in plant-based fats and proteins was associated with a lower risk of mortality.
Fung, who teaches at the Simmons College School of Health Sciences, led the study with colleagues at the Harvard School of Public Health and Channing Laboratory, Brigham and Women's Hospital.
"This research indicates that all low carb diets are not the same, and the differences have an indelible impact," Fung said. "One that is based on plant foods is a better choice than one that is based on animal foods."
The study is based on two cohorts of participants: more than 85,000 women enrolled in the Nurse's Health Study (ages 34 to 59) who provided dietary information for 26 years; and more than 44,500 men enrolled the Health Professional's Follow Up Study (ages 40 to 75) who provided dietary information for 20 years. All participants included in the study were free of heart disease, cancer or diabetes. The Nurses' Health Study is based at Channing Laboratory, Brigham and Women's Hospital and the Health Professionals' Follow-up Study is based at Harvard School of Public Health.
In determining health risk, the study created low carbohydrate scores for the women and men, based on a multi-year evaluation of their diet intake with a focus on the proportion of carbohydrates, and fat and protein - whether derived largely from animal or vegetable-based sources.
During follow ups with the men and women, the study found that those who had a diet made up of more animal-based sources and a low-carbohydrate intake , scored higher for association with "all-cause" mortality and cancer mortality., Those who had a diet made up of more plant-based sources and a low-carbohydrate intake, scored lower for association with "all-cause" mortality, and cancer and cardiovascular mortality.
Participants with a higher animal low carbohydrate score were heavier and were more likely to be smokers, whereas those with a higher vegetable low carbohydrate score consumed more alcohol and whole grains. Variations in lifestyle and other dietary issues, such as smoking status, family history of colorectal cancer, aspirin use, and history of hypertension were controlled in the analyses.
The National Institutes of Health funded the study, "Low-Carbohydrate Diets and All-Cause and Cause-Specific Mortality: Two Cohort Studies."
-----
Community News You Can Use
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
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This study is the first of its kind to demonstrate the link between different types of low carbohydrate diets and mortality. It also sought to determine the long-term impact of low carbohydrate diets, which have been promoted as an effective option for weight loss and improving health.
Conversely, the study found that a diet low in carbohydrates but rich in plant-based fats and proteins was associated with a lower risk of mortality.
Fung, who teaches at the Simmons College School of Health Sciences, led the study with colleagues at the Harvard School of Public Health and Channing Laboratory, Brigham and Women's Hospital.
"This research indicates that all low carb diets are not the same, and the differences have an indelible impact," Fung said. "One that is based on plant foods is a better choice than one that is based on animal foods."
The study is based on two cohorts of participants: more than 85,000 women enrolled in the Nurse's Health Study (ages 34 to 59) who provided dietary information for 26 years; and more than 44,500 men enrolled the Health Professional's Follow Up Study (ages 40 to 75) who provided dietary information for 20 years. All participants included in the study were free of heart disease, cancer or diabetes. The Nurses' Health Study is based at Channing Laboratory, Brigham and Women's Hospital and the Health Professionals' Follow-up Study is based at Harvard School of Public Health.
In determining health risk, the study created low carbohydrate scores for the women and men, based on a multi-year evaluation of their diet intake with a focus on the proportion of carbohydrates, and fat and protein - whether derived largely from animal or vegetable-based sources.
During follow ups with the men and women, the study found that those who had a diet made up of more animal-based sources and a low-carbohydrate intake , scored higher for association with "all-cause" mortality and cancer mortality., Those who had a diet made up of more plant-based sources and a low-carbohydrate intake, scored lower for association with "all-cause" mortality, and cancer and cardiovascular mortality.
Participants with a higher animal low carbohydrate score were heavier and were more likely to be smokers, whereas those with a higher vegetable low carbohydrate score consumed more alcohol and whole grains. Variations in lifestyle and other dietary issues, such as smoking status, family history of colorectal cancer, aspirin use, and history of hypertension were controlled in the analyses.
The National Institutes of Health funded the study, "Low-Carbohydrate Diets and All-Cause and Cause-Specific Mortality: Two Cohort Studies."
-----
Community News You Can Use
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter: @GAFrontPage
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