The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.
Terbutaline is FDA-approved to prevent and treat narrowing of the airways (bronchospasm) associated with asthma, bronchitis, and emphysema. The drug is used off-label for obstetric purposes, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used in an attempt to prevent recurrent preterm labor. There is no evidence, however, that use of terbutaline to prevent preterm labor improves infant outcomes. Serious adverse events, including maternal deaths, have been reported with such use in pregnant patients.
“Women should be aware that serious and sometimes fatal side effects have been reported after prolonged use of terbutaline in pregnant women,” said Scott Monroe, M.D., director of FDA’s Division of Reproductive and Urologic Products. “It is important for patients and health care professionals to consider all the potential risks and known benefits of any drug before deciding on its use.”
The FDA is aware that administration of terbutaline by injection to pregnant women is used in hospital settings in certain urgent situations. The FDA warning relates to safety concerns about the prolonged use of terbutaline injection beyond 48-72 hours, and against any use of oral terbutaline in pregnant women for prevention or treatment of preterm labor.
The decision to require a Boxed Warning and Contraindication is based on the FDA’s review of post-market safety reports of heart problems and even death associated with terbutaline use for obstetric indications, as well as data from medical literature documenting the lack of safety and effectiveness of terbutaline for preventing preterm labor, and animal data suggesting potential risks. Based on this information, the FDA concluded that the risk of serious adverse events outweighs any potential benefit to pregnant patients for either prolonged use of terbutaline injection beyond 48-72 hours or use of oral terbutaline for prevention or treatment of preterm labor.
These changes to the drug labeling are consistent with statements from the American College of Obstetricians and Gynecologists discouraging use of terbutaline for preventing preterm labor.
There are multiple generic versions of terbutaline oral tablets and injectable formulations available. The brand name products were previously discontinued by the companies that made them.
The FDA encourages patients to talk to their health care professional if they have concerns about any treatment they are receiving. Patients and health care professionals should report any side effects from the use of terbutaline to the FDA’s MedWatch adverse event reporting program at www.fda.gov/MedWatch1.
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Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts
Wednesday, February 23, 2011
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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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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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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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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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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Tuesday, September 14, 2010
Upcoming FDA Hearing on Abuse of Cough and Cold Medications Misses the Mark
/PRNewswire/ -- The Center for Medicine in the Public Interest released the results of a national Teen Substance Abuse survey today, indicating that police officers and high school teachers nationwide believe alcohol and marijuana are the most serious problem substances facing teenagers. These survey results come as the Food and Drug Administration has scheduled an Advisory Committee meeting for September 14 to examine whether abuse of cough and cold medications by teens requires stricter controls on the sale of those commonly used products.
Police and teachers polled do not believe it is a good idea to force Americans to visit a doctor to get a prescription to purchase commonly sold cough and cold medicines. However, an FDA Advisory Committee next week could decide to make more than 100 brand name, over-the-counter cold and cough medicines containing the ingredient dextromethorphan available only through a doctor's prescription or place them behind the counter at pharmacies, forcing customers to receive assistance from a pharmacist or store employee to get the medicines.
When asked which substances pose the greatest negative impact on teens, teachers and police overwhelmingly identified marijuana and alcohol, followed by methamphetamine and cocaine. Additionally, no police and only 1% of high school teachers cited cough and cold medicines as having the greatest negative impact on teens.
The survey also reveals that by a margin of two to one, police officers and high school teachers support education efforts as a means to address abuse of over-the-counter cough and cold medicines, versus restricted accessibility to consumers.
"Americans expect to be able to buy cough medicines conveniently at the supermarket or their neighborhood corner store," says CMPI Vice President Robert Goldberg, Ph.D. "Overly restricting access to cough and cold products containing dextromethorphan will create more health problems than it will solve, especially during cold and flu seasons. We need to find common sense solutions and invest more resources in education."
The entire Teen Substance Abuse survey is available at www.cmpi.org and the poll was conducted by Fabrizio Ward and Associates.
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Police and teachers polled do not believe it is a good idea to force Americans to visit a doctor to get a prescription to purchase commonly sold cough and cold medicines. However, an FDA Advisory Committee next week could decide to make more than 100 brand name, over-the-counter cold and cough medicines containing the ingredient dextromethorphan available only through a doctor's prescription or place them behind the counter at pharmacies, forcing customers to receive assistance from a pharmacist or store employee to get the medicines.
When asked which substances pose the greatest negative impact on teens, teachers and police overwhelmingly identified marijuana and alcohol, followed by methamphetamine and cocaine. Additionally, no police and only 1% of high school teachers cited cough and cold medicines as having the greatest negative impact on teens.
When you think of substance abuse, which substances do you see as having the greatest negative impact on teens? Police H.S. Teachers ------------------------------------ ------ ------------- Alcohol//beer 51% 70% ------------- --- --- Marijuana//pot 69% 51% Prescription drugs//prescription pills 27% 15% -------------------------------- --- --- Methamphetamine//crystal methamphetamine 28% 9% Cocaine//coke//crack 22% 8% -------------------- --- --- Heroin 12% 3% Ecstasy 6% 5% ------- --- --- Cigarettes//tobacco 3% 6% Inhalants//spray can fumes 3% - -------------------------- --- --- Over the counter medicine//non prescription medication 1% 2% Cough//Medicines//Cold Medicines//DXM - 1%CMPI's study also shows that alcohol, marijuana, prescription drugs, methamphetamine, cocaine and cigarettes are cited among the top substances posing the most serious problems to teens:
% Selecting as Most/2(nd) Most/ 3(rd) Most Serious Problem Substance Police H.S. Teachers ----------------------------------- ------ ------------- Alcohol 82% 88% ------- --- --- Pot 76% 75% --- --- --- Prescription drugs 41% 27% ------------------ --- --- Meth 32% 22% ---- --- --- Cigarettes 14% 36% ---------- --- --- Cocaine/Crack 27% 15% ------------- --- --- Ecstasy 5% 9% ------- --- --- OTC cough and cold medicine 5% 8%
The survey also reveals that by a margin of two to one, police officers and high school teachers support education efforts as a means to address abuse of over-the-counter cough and cold medicines, versus restricted accessibility to consumers.
"Americans expect to be able to buy cough medicines conveniently at the supermarket or their neighborhood corner store," says CMPI Vice President Robert Goldberg, Ph.D. "Overly restricting access to cough and cold products containing dextromethorphan will create more health problems than it will solve, especially during cold and flu seasons. We need to find common sense solutions and invest more resources in education."
The entire Teen Substance Abuse survey is available at www.cmpi.org and the poll was conducted by Fabrizio Ward and Associates.
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Wednesday, August 25, 2010
FDA Warns Consumers to Avoid TimeOut Capsules
The U.S. Food and Drug Administration is warning consumers not to take TimeOut Capsules because it contains an active drug ingredient that can dangerously lower blood pressure. The product is marketed as a dietary supplement for sexual enhancement.
TimeOut is labeled as “100% natural” and consumers may mistakenly assume the product is harmless and poses no health risk. TimeOut is distributed on Internet sites and online marketplaces as 2,500 mg capsules.
Consumers who have TimeOut Capsules should stop using them immediately. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or death.
The FDA analyzed TimeOut and determined that it contains hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, this chemical may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure. When blood pressure drops suddenly, the brain is deprived of an adequate blood supply which can lead to dizziness or lightheadedness.
To date, the FDA is not aware of any adverse events associated with the use of this product.
The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to consult a health care professional and to safely discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online.
During the past several years, the FDA has found many products marketed as dietary supplements for sexual enhancement that can be harmful to consumers because they are adulterated with ingredients in FDA-approved drugs or variations of these ingredients.
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TimeOut is labeled as “100% natural” and consumers may mistakenly assume the product is harmless and poses no health risk. TimeOut is distributed on Internet sites and online marketplaces as 2,500 mg capsules.
Consumers who have TimeOut Capsules should stop using them immediately. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or death.
The FDA analyzed TimeOut and determined that it contains hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, this chemical may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure. When blood pressure drops suddenly, the brain is deprived of an adequate blood supply which can lead to dizziness or lightheadedness.
To date, the FDA is not aware of any adverse events associated with the use of this product.
The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to consult a health care professional and to safely discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online.
During the past several years, the FDA has found many products marketed as dietary supplements for sexual enhancement that can be harmful to consumers because they are adulterated with ingredients in FDA-approved drugs or variations of these ingredients.
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Tuesday, August 24, 2010
FDA Warns of Possible Dangers from Portable Foot-Tanning Device
The U.S. Food and Drug Administration is warning consumers about the risk of ultraviolet radiation overdose with the Tootsie Tanner portable foot tanning device.
Use of the tanning device can lead to an overdose of ultraviolet radiation because its labeling recommends an improper duration of exposure to radiation and the device has an inadequate timer. The labeled exposure schedule indicates that the device may be used for 30 minutes, and the timer control permits 30 minutes exposure. Based on FDA testing, the maximum exposure time for this device is 20 minutes.
The device fails to provide prominent warnings about the need for protective eyewear. Use of this product according to the labeling could result in an overdose of ultraviolet radiation, which may cause immediate and delayed serious eye and skin injuries.
The FDA has issued a warning letter to the device manufacturer and distributor, IPCH, located in Sugarland, Texas. Since issuing the warning letter, the FDA learned that IPCH is no longer in business. Thus, the device will not be replaced or updated with the correct labeling. Refunds will not be available for the estimated 3,000 devices sold.
The FDA recommends that users of this device, which include tanning salon owners and operators, stop using this device, remove the lamps and safely discard all components of the device according to local environmental protection standards.
Although the FDA has received no adverse event reports to date, the agency is concerned about the risk of eye and skin injuries from an overdose of ultraviolet radiation.
Consumers may report serious adverse events (side effects) with the device to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone.
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Use of the tanning device can lead to an overdose of ultraviolet radiation because its labeling recommends an improper duration of exposure to radiation and the device has an inadequate timer. The labeled exposure schedule indicates that the device may be used for 30 minutes, and the timer control permits 30 minutes exposure. Based on FDA testing, the maximum exposure time for this device is 20 minutes.
The device fails to provide prominent warnings about the need for protective eyewear. Use of this product according to the labeling could result in an overdose of ultraviolet radiation, which may cause immediate and delayed serious eye and skin injuries.
The FDA has issued a warning letter to the device manufacturer and distributor, IPCH, located in Sugarland, Texas. Since issuing the warning letter, the FDA learned that IPCH is no longer in business. Thus, the device will not be replaced or updated with the correct labeling. Refunds will not be available for the estimated 3,000 devices sold.
The FDA recommends that users of this device, which include tanning salon owners and operators, stop using this device, remove the lamps and safely discard all components of the device according to local environmental protection standards.
Although the FDA has received no adverse event reports to date, the agency is concerned about the risk of eye and skin injuries from an overdose of ultraviolet radiation.
Consumers may report serious adverse events (side effects) with the device to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone.
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Thursday, August 19, 2010
U.S. Appeals Court Reinstates Claim That Controversial Diet Drug Redux Should Never Have Been Offered to American People
/PRNewswire/ -- An Ohio Federal Court of Appeals ruling issued yesterday is reinstating the late victim's claim that the recalled diet drug Redux (commonly called fen-phen) linked to her death should never have been marketed to the American people by Wyeth due in part to its pre-approval concerns about potentially lethal side effects. The Court, in remanding the case to the trial court, held that Federal drug regulations do not preempt Ohio negligence claims, and indicated that the Supreme Court's 2009 landmark pharmaceutical manufacturer preemption decision (Wyeth v. Levine) may apply beyond inadequate warning-label claims.
Benjamin H. Anderson, Esq., of Anderson Law Offices, LLC of Cleveland, Ohio, counsel for the plaintiff, said, "Mary Buchanan, like so many others, turned to a drug to help her lose weight and as a result she lost her life. She and her surviving family members deserve justice; this is an important decision in her case and for the harms and losses she sustained, as well as the many millions of Americans taking prescription medications who have long been concerned about drug companies being shielded from appropriate state negligence laws. Significantly, the appeals court has also reinstated and remanded to the trial court our claim for punitive damages."
In reversing key sections of the trial court's finding for the defendant on summary judgment in Wimbush v. Wyeth et.al., 6th Cir. No. 09-3380, the three-judge appeals panel held that the trial judge erred in concluding that the U.S. Food and Drug Administration (FDA) preempted the Buchanan family's negligence claims that the drug should never have been made available to Americans given Wyeth-Redux's known health risks, particularly Primary Pulmonary Hypertension (PPH). Mrs. Buchanan, a hard-working and dedicated 66- year-old nurse from Maple Heights, Ohio who took the weight-loss drug during 1996 and 1997, lost her life to PPH in 2003 within a few months after filing the complaint. The drug company, which spent more than $50 million marketing the wildly popular and profitable drug after its launch in April 1996, pulled it on September 15, 1997 at the request of the FDA and under mounting criticism by independent researchers and reports in respected medical journals.
Though Redux was only on the market for a relatively short period, to date it is estimated that Wyeth has paid thousands of victims of Redux and its predecessor, Pondimin - and/or their survivors - more than $20 billion in damages. In evaluating the potential side effects of Redux, researchers noted that PPH is a devastating pulmonary disease for which there is still no cure, and the associated heart-valve problems may and often did require high-risk heart surgery. The controversial, high-risk diet drug had previously been evaluated and pulled from pharmacies overseas and it was banned in some individual states before the total recall.
In its decision, the appeals Court stated, "...we are not persuaded that it is always impossible to comply with both state law duties and FDA regulations in the process leading up to FDA approval." It added, "...we cannot agree with the district court's conclusion as, not only is there a presumption against preemption, but the case law supports the conclusion that Congress did not intend to preempt state tort law claims when it passed the Food, Drug, and Cosmetics Act (FDCA)."
In a footnote, it commented "...the overwhelming take-away from the Levine majority opinion is that state tort law has historically played a substantial role in the regulation of drug manufacturers and that Congress has never indicated an intent to change this role. Thus, while Levine did leave open the possibility that there may be some state law claims that would conflict with the FDA's regulatory authority and function, the claim at issue in Levine was not one of them. We do not believe that Buchanan's pre-approval negligence claims are, either."
Attorney Anderson, commenting on the interpretation of the Levine ruling in the case, said, "Drug companies are now on notice that they cannot lie to and conceal from the FDA crucial information in the pre-approval process and then expect to be held harmless once their drugs are responsible for causing pain, suffering and, as in Mrs. Buchanan's case, death."
The Court affirmed the dismissal of the balance of the plaintiff's claims, and Attorney Anderson said he will evaluate with appellate counsel Paul Flowers, Esq., and Mrs. Buchanan's family all appropriate legal options.
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Benjamin H. Anderson, Esq., of Anderson Law Offices, LLC of Cleveland, Ohio, counsel for the plaintiff, said, "Mary Buchanan, like so many others, turned to a drug to help her lose weight and as a result she lost her life. She and her surviving family members deserve justice; this is an important decision in her case and for the harms and losses she sustained, as well as the many millions of Americans taking prescription medications who have long been concerned about drug companies being shielded from appropriate state negligence laws. Significantly, the appeals court has also reinstated and remanded to the trial court our claim for punitive damages."
In reversing key sections of the trial court's finding for the defendant on summary judgment in Wimbush v. Wyeth et.al., 6th Cir. No. 09-3380, the three-judge appeals panel held that the trial judge erred in concluding that the U.S. Food and Drug Administration (FDA) preempted the Buchanan family's negligence claims that the drug should never have been made available to Americans given Wyeth-Redux's known health risks, particularly Primary Pulmonary Hypertension (PPH). Mrs. Buchanan, a hard-working and dedicated 66- year-old nurse from Maple Heights, Ohio who took the weight-loss drug during 1996 and 1997, lost her life to PPH in 2003 within a few months after filing the complaint. The drug company, which spent more than $50 million marketing the wildly popular and profitable drug after its launch in April 1996, pulled it on September 15, 1997 at the request of the FDA and under mounting criticism by independent researchers and reports in respected medical journals.
Though Redux was only on the market for a relatively short period, to date it is estimated that Wyeth has paid thousands of victims of Redux and its predecessor, Pondimin - and/or their survivors - more than $20 billion in damages. In evaluating the potential side effects of Redux, researchers noted that PPH is a devastating pulmonary disease for which there is still no cure, and the associated heart-valve problems may and often did require high-risk heart surgery. The controversial, high-risk diet drug had previously been evaluated and pulled from pharmacies overseas and it was banned in some individual states before the total recall.
In its decision, the appeals Court stated, "...we are not persuaded that it is always impossible to comply with both state law duties and FDA regulations in the process leading up to FDA approval." It added, "...we cannot agree with the district court's conclusion as, not only is there a presumption against preemption, but the case law supports the conclusion that Congress did not intend to preempt state tort law claims when it passed the Food, Drug, and Cosmetics Act (FDCA)."
In a footnote, it commented "...the overwhelming take-away from the Levine majority opinion is that state tort law has historically played a substantial role in the regulation of drug manufacturers and that Congress has never indicated an intent to change this role. Thus, while Levine did leave open the possibility that there may be some state law claims that would conflict with the FDA's regulatory authority and function, the claim at issue in Levine was not one of them. We do not believe that Buchanan's pre-approval negligence claims are, either."
Attorney Anderson, commenting on the interpretation of the Levine ruling in the case, said, "Drug companies are now on notice that they cannot lie to and conceal from the FDA crucial information in the pre-approval process and then expect to be held harmless once their drugs are responsible for causing pain, suffering and, as in Mrs. Buchanan's case, death."
The Court affirmed the dismissal of the balance of the plaintiff's claims, and Attorney Anderson said he will evaluate with appellate counsel Paul Flowers, Esq., and Mrs. Buchanan's family all appropriate legal options.
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Monday, August 16, 2010
Independent Toxicologists Issue Warning: We Object to the Claim That Chemical Dispersants Have A Low Potential For Accumulating in Marine Life and Do Not Pose an Environmental Health Concern
/PRNewswire/ -- Attorney Stuart H. Smith, representing the United Commercial Fishermen's Association, the Louisiana Environmental Action Network, public and private entities, and citizens harmed by the BP oil catastrophe, today issued this statement:
"Independent analysis by toxicologists dispute FDA claims made in the last few days that chemical dispersants used by BP during the oil catastrophe may not accumulate in marine animals.
"In fact, in a full report by Dr. Bill Sawyer released today, there is a grave problem caused by dispersants, due to the fact that these were used in deep waters and on such a vast scale.
"Studies of other spills show that the toxic components of crude oil 'bio-accumulate' into the food chain and become highly toxic to marine reproduction, even when dispersants are applied at the surface and the chemical toxins may be sufficiently diluted over time to pose only minimal risks.
"However, BP's use of dispersants deep underwater in the Gulf, and on such a vast scale, represents the first time dispersants have been used in this manner. The greatly-reduced biodegradation in the DEEPWATER HORIZON case, resulting from lack of sunlight, extreme cold temperatures at 5,000 feet, and other environmental factors significantly reduce the rate at which the dispersed crude components are degraded.
"Eight months would be required to remove 96 percent of the petroleum under ideal conditions, thus we can only assume what remains in the Gulf waters will be a 'toxic soup' of chemicals for the foreseeable future, due to the worst-case scenario which has unfolded.
"The most potentially dangerous of the components in the Gulf's toxic soup are 'polynuclear aromatic hydrocarbons' (PAHs), dangerous cancer-causing chemicals which slowly break down after being ingested by marine life, persist in marine organisms and can be passed to both humans and other wildlife through consumption.
"PAHs are not contained within the dispersants used, but rather, have been extracted from the BP crude and suspended in the water column via dispersant use.
"It must also be noted that the deep water National Oceanic and Atmospheric Administration Weatherbird analyses and our own near shore water, tunicate and beach samples have revealed a consistent pattern of dispersant-induced C19-C36 hydrocarbons and PAHs. Unfortunately, these specific PAHs are of the most toxic variety."
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"Independent analysis by toxicologists dispute FDA claims made in the last few days that chemical dispersants used by BP during the oil catastrophe may not accumulate in marine animals.
"In fact, in a full report by Dr. Bill Sawyer released today, there is a grave problem caused by dispersants, due to the fact that these were used in deep waters and on such a vast scale.
"Studies of other spills show that the toxic components of crude oil 'bio-accumulate' into the food chain and become highly toxic to marine reproduction, even when dispersants are applied at the surface and the chemical toxins may be sufficiently diluted over time to pose only minimal risks.
"However, BP's use of dispersants deep underwater in the Gulf, and on such a vast scale, represents the first time dispersants have been used in this manner. The greatly-reduced biodegradation in the DEEPWATER HORIZON case, resulting from lack of sunlight, extreme cold temperatures at 5,000 feet, and other environmental factors significantly reduce the rate at which the dispersed crude components are degraded.
"Eight months would be required to remove 96 percent of the petroleum under ideal conditions, thus we can only assume what remains in the Gulf waters will be a 'toxic soup' of chemicals for the foreseeable future, due to the worst-case scenario which has unfolded.
"The most potentially dangerous of the components in the Gulf's toxic soup are 'polynuclear aromatic hydrocarbons' (PAHs), dangerous cancer-causing chemicals which slowly break down after being ingested by marine life, persist in marine organisms and can be passed to both humans and other wildlife through consumption.
"PAHs are not contained within the dispersants used, but rather, have been extracted from the BP crude and suspended in the water column via dispersant use.
"It must also be noted that the deep water National Oceanic and Atmospheric Administration Weatherbird analyses and our own near shore water, tunicate and beach samples have revealed a consistent pattern of dispersant-induced C19-C36 hydrocarbons and PAHs. Unfortunately, these specific PAHs are of the most toxic variety."
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Monday, August 09, 2010
FDA Warns of Salmonella Risk From Frozen Rodents Fed to Reptiles
/PRNewswire/ -- The U.S. Food and Drug Administration is warning U.S. and international customers who may have purchased frozen mice from Biggers and Callaham LLC, doing business as MiceDirect, that these products, which are used as food for reptiles, have the potential to be contaminated with Salmonella.
Because children, the elderly, and individuals with weakened immune systems are particularly at risk for salmonellosis, they should avoid handling either frozen rodents used as reptile food or reptiles. Children 5 years and under should not handle either frozen rodents used as reptile food or reptiles.
After handling either frozen rodents used as reptile food or reptiles themselves, individuals should thoroughly wash their hands with soap and water and use a disinfectant to thoroughly clean any surfaces that have been in contact with frozen rodents.
The FDA is actively investigating positive Salmonella findings in frozen mice and environmental samples taken at the company's Cleveland, Ga. plant. After being informed of the positive samples, Biggers and Callaham voluntarily recalled all frozen mice, rats and chicks purchased between May 2009 and July 23, 2010. The frozen reptile feed was distributed in all states, except Hawaii, through pet stores and by mail order and direct delivery.
On Aug. 2, 2010, the Centers for Disease Control and Prevention (CDC) reported that 34 human illnesses in 17 states were associated with handling frozen rodents used for reptile food sourced from Biggers and Callaham. In general, snakes and other reptiles can harbor many strains of Salmonella for several years, but still appear healthy.
Frozen reptile feed was shipped in plastic bags with the following product codes M-SP100, M-P100, M-PF100, M-F100, M-H100, M-W50, M-A50, M-JA25, R-P100, R-F50, R-PUP50, R-W50, R-S50, R-M20, R-L10,R-J5, R-C5, R-M3 followed by E9, F9, G9, H9, I9, J9, K9, L9 or A10, B10, C10, D10, E10, F10, G10 and whole frozen chicks in 25 count bags.
The FDA advises customers with the contaminated product to place it in a sealed container in the trash so that no children, pets, or other animals, such as wildlife, may be able to reach it.
Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. People infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. Most people recover from Salmonella infections within four to seven days without treatment. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses, such as arterial infections (infected aneurysms), infection of the lining of the heart, and arthritis.
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Because children, the elderly, and individuals with weakened immune systems are particularly at risk for salmonellosis, they should avoid handling either frozen rodents used as reptile food or reptiles. Children 5 years and under should not handle either frozen rodents used as reptile food or reptiles.
After handling either frozen rodents used as reptile food or reptiles themselves, individuals should thoroughly wash their hands with soap and water and use a disinfectant to thoroughly clean any surfaces that have been in contact with frozen rodents.
The FDA is actively investigating positive Salmonella findings in frozen mice and environmental samples taken at the company's Cleveland, Ga. plant. After being informed of the positive samples, Biggers and Callaham voluntarily recalled all frozen mice, rats and chicks purchased between May 2009 and July 23, 2010. The frozen reptile feed was distributed in all states, except Hawaii, through pet stores and by mail order and direct delivery.
On Aug. 2, 2010, the Centers for Disease Control and Prevention (CDC) reported that 34 human illnesses in 17 states were associated with handling frozen rodents used for reptile food sourced from Biggers and Callaham. In general, snakes and other reptiles can harbor many strains of Salmonella for several years, but still appear healthy.
Frozen reptile feed was shipped in plastic bags with the following product codes M-SP100, M-P100, M-PF100, M-F100, M-H100, M-W50, M-A50, M-JA25, R-P100, R-F50, R-PUP50, R-W50, R-S50, R-M20, R-L10,R-J5, R-C5, R-M3 followed by E9, F9, G9, H9, I9, J9, K9, L9 or A10, B10, C10, D10, E10, F10, G10 and whole frozen chicks in 25 count bags.
The FDA advises customers with the contaminated product to place it in a sealed container in the trash so that no children, pets, or other animals, such as wildlife, may be able to reach it.
Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. People infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. Most people recover from Salmonella infections within four to seven days without treatment. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses, such as arterial infections (infected aneurysms), infection of the lining of the heart, and arthritis.
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Saturday, July 31, 2010
FDA Warns Consumers of Serious Harm from Drinking Miracle Mineral Solution (MMS)
/PRNewswire/ -- The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid solution also known as "Miracle Mineral Supplement" or "MMS." The product, when used as directed, produces an industrial bleach that can cause serious harm to health.
The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.
Consumers who have MMS should stop using it immediately and throw it away.
MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary.
The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.
MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.
The FDA continues to investigate and may pursue civil or criminal enforcement actions as appropriate to protect the public from this potentially dangerous product.
The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible and to discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.
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The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.
Consumers who have MMS should stop using it immediately and throw it away.
MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary.
The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.
MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.
The FDA continues to investigate and may pursue civil or criminal enforcement actions as appropriate to protect the public from this potentially dangerous product.
The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible and to discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.
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Thursday, July 29, 2010
FDA Advisory: Avoid Unintentional Exposure of Children and Pets to Evamist
/PRNewswire/ -- The U.S. Food and Drug Administration is warning that inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets.
Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. The FDA currently is reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product.
"Women using Evamist need to be aware of the potential risks to children who come in contact with the area of skin where this drug is applied," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III. "It is important that people know to keep both children and pets away from the product to minimize exposure."
Evamist was FDA approved in 2007. From July 2007 to June 2010, FDA received eight post-marketing cases of unintended exposure to Evamist in children ages 3 years to 5 years. Adverse events reported in unintentionally exposed children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males. Since 2007, two reports of secondary exposure to Evamist in dogs also have been received by FDA's Center for Veterinary Medicine. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling.
Patients using Evamist should not allow children to make contact with the area of the arm where Evamist is sprayed and should wash the child's skin with soap and water as soon as possible if contact does occur. Pets also should not be allowed to lick or touch the arm where Evamist is sprayed as small pets may be especially sensitive to the estrogen in this product. If direct contact with the arm where Evamist was sprayed cannot be avoided, it is recommended that women wear a garment that covers the area where the drug was applied.
At this time, it is unknown whether unintended exposure can occur with other topical estrogen products. The FDA is continuing to review adverse event reports and evaluate ways to reduce unintended exposures to these products.
Consumers and health care professionals should report any side effects from Evamist by using the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.
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Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. The FDA currently is reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product.
"Women using Evamist need to be aware of the potential risks to children who come in contact with the area of skin where this drug is applied," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III. "It is important that people know to keep both children and pets away from the product to minimize exposure."
Evamist was FDA approved in 2007. From July 2007 to June 2010, FDA received eight post-marketing cases of unintended exposure to Evamist in children ages 3 years to 5 years. Adverse events reported in unintentionally exposed children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males. Since 2007, two reports of secondary exposure to Evamist in dogs also have been received by FDA's Center for Veterinary Medicine. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling.
Patients using Evamist should not allow children to make contact with the area of the arm where Evamist is sprayed and should wash the child's skin with soap and water as soon as possible if contact does occur. Pets also should not be allowed to lick or touch the arm where Evamist is sprayed as small pets may be especially sensitive to the estrogen in this product. If direct contact with the arm where Evamist was sprayed cannot be avoided, it is recommended that women wear a garment that covers the area where the drug was applied.
At this time, it is unknown whether unintended exposure can occur with other topical estrogen products. The FDA is continuing to review adverse event reports and evaluate ways to reduce unintended exposures to these products.
Consumers and health care professionals should report any side effects from Evamist by using the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.
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Monday, June 21, 2010
FDA Warns Consumers to Avoid Magic Power Coffee
The U.S. Food and Drug Administration is warning consumers that Magic Power Coffee, an instant coffee product marketed as a dietary supplement for sexual enhancement, contains an active drug ingredient that can dangerously lower blood pressure.
Consumers who have Magic Power Coffee should stop using it immediately. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death.
In the case of Magic Power Coffee, the FDA collected and analyzed the product and determined that the product contains hydroxythiohomosildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Hydroxythiohomosildenafil, like sildenafil, may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. Consumers and health care professionals should be aware of this problem and the health hazard it presents.
When blood pressure drops suddenly, the brain is deprived of an adequate blood supply, which can lead to dizziness or lightheadedness.
"Because this product is an instant coffee labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research, Office of Compliance. "In fact, Magic Power Coffee can cause serious harm.”
To date, the FDA is not aware of any adverse events associated with the use of this product.
The product is distributed on Internet sites and online auctions by multiple independent distributors participating in an online multi-level marketing scheme. It is sold in a 2-serving box and a 12-serving carton containing six 2-serving boxes.
The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to consult a health care professional and to safely discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm
During the past several years, the FDA has found many products marketed as dietary supplements for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs or other compounds that do not qualify as “dietary ingredients.”
“The FDA is committed to protecting public health and stopping the illegal marketing of unapproved drugs,” said Autor. “We support vigorous law enforcement and criminal prosecution of violators of safe drug laws.
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Consumers who have Magic Power Coffee should stop using it immediately. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death.
In the case of Magic Power Coffee, the FDA collected and analyzed the product and determined that the product contains hydroxythiohomosildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Hydroxythiohomosildenafil, like sildenafil, may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. Consumers and health care professionals should be aware of this problem and the health hazard it presents.
When blood pressure drops suddenly, the brain is deprived of an adequate blood supply, which can lead to dizziness or lightheadedness.
"Because this product is an instant coffee labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research, Office of Compliance. "In fact, Magic Power Coffee can cause serious harm.”
To date, the FDA is not aware of any adverse events associated with the use of this product.
The product is distributed on Internet sites and online auctions by multiple independent distributors participating in an online multi-level marketing scheme. It is sold in a 2-serving box and a 12-serving carton containing six 2-serving boxes.
The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to consult a health care professional and to safely discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm
During the past several years, the FDA has found many products marketed as dietary supplements for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs or other compounds that do not qualify as “dietary ingredients.”
“The FDA is committed to protecting public health and stopping the illegal marketing of unapproved drugs,” said Autor. “We support vigorous law enforcement and criminal prosecution of violators of safe drug laws.
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Thursday, June 17, 2010
FDA Warns About Fraudulent Tamiflu
/USNewswire/ -- The U.S. Food and Drug Administration today warned consumers about a potentially harmful product represented as "Generic Tamiflu" sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu's active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.
The agency reminds patients who are allergic to or may have experienced adverse reactions from penicillin products that they are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse. To date, the FDA is not aware of any reports of adverse reactions.
There is no FDA-approved generic drug for the prescription product Tamiflu.
The FDA bought the fraudulent "Generic Tamiflu" without a prescription from a website claiming to be an online drugstore that is no longer operational. The fraudulent version is likely to be found for sale on other websites, however.
"A rogue Internet website marketing drug products may look like a professional and legitimate website, but may actually be an illegal operation," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "Medicines purchased from websites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient."
The FDA-purchased product arrived in an envelope postmarked from India, containing two foil-backed blister packages each with 15 yellow and tan capsules containing white powder (see photos below). The foil backing is printed, and labeled in part, "Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules" and "Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD."
Although the FDA actively monitors the Internet and when appropriate purchases and analyzes drug products, consumers who purchase drugs using an online pharmacy can protect themselves by knowing how to recognize a legitimate Internet pharmacy and how to buy medicines safely online. Legitimate internet pharmacies are licensed by the appropriate U.S. Board of Pharmacy and follow the applicable laws and regulations.
Consumers can also be confident that the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, also known as VIPPS Seal, gives a seal of approval to pharmacy sites that apply and meet state licensure requirements. Legitimate pharmacies that carry the VIPPS seal are listed at www.vipps.info
The FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA's Office of Criminal Investigations by calling 800-551-3989, or by visiting the OCI website (http://www.fda.gov/OCI).
Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these fraudulent products to the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
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The agency reminds patients who are allergic to or may have experienced adverse reactions from penicillin products that they are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse. To date, the FDA is not aware of any reports of adverse reactions.
There is no FDA-approved generic drug for the prescription product Tamiflu.
The FDA bought the fraudulent "Generic Tamiflu" without a prescription from a website claiming to be an online drugstore that is no longer operational. The fraudulent version is likely to be found for sale on other websites, however.
"A rogue Internet website marketing drug products may look like a professional and legitimate website, but may actually be an illegal operation," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "Medicines purchased from websites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient."
The FDA-purchased product arrived in an envelope postmarked from India, containing two foil-backed blister packages each with 15 yellow and tan capsules containing white powder (see photos below). The foil backing is printed, and labeled in part, "Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules" and "Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD."
Although the FDA actively monitors the Internet and when appropriate purchases and analyzes drug products, consumers who purchase drugs using an online pharmacy can protect themselves by knowing how to recognize a legitimate Internet pharmacy and how to buy medicines safely online. Legitimate internet pharmacies are licensed by the appropriate U.S. Board of Pharmacy and follow the applicable laws and regulations.
Consumers can also be confident that the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, also known as VIPPS Seal, gives a seal of approval to pharmacy sites that apply and meet state licensure requirements. Legitimate pharmacies that carry the VIPPS seal are listed at www.vipps.info
The FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA's Office of Criminal Investigations by calling 800-551-3989, or by visiting the OCI website (http://www.fda.gov/OCI).
Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these fraudulent products to the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
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Tuesday, June 15, 2010
FDA Cautions on Accurate Vitamin D Supplementation for Infants
The Food and Drug Administration today alerted parents and caregivers that some liquid Vitamin D supplement products are sold with droppers that could allow excessive dosing of Vitamin D to infants.
The FDA also advised manufacturers of liquid Vitamin D supplements that droppers accompanying these products should be clearly and accurately marked for 400 international units (IU). In addition, for products intended for infants, FDA recommends that the dropper hold no more than 400 IU.
The American Academy of Pediatrics (AAP) has recommended a dose of 400 IU of Vitamin D supplement per day to breast-fed and partially breast-fed infants. The easiest way to ensure that an infant will not get more than the recommended dose is to use a product supplied with a dropper that will give no more than 400 IU per dose. The AAP’s recommendations are provided hereExit Disclaimer.
Excessive amounts of Vitamin D can be harmful to infants, and may be characterized by nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences such as kidney damage.
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The FDA also advised manufacturers of liquid Vitamin D supplements that droppers accompanying these products should be clearly and accurately marked for 400 international units (IU). In addition, for products intended for infants, FDA recommends that the dropper hold no more than 400 IU.
The American Academy of Pediatrics (AAP) has recommended a dose of 400 IU of Vitamin D supplement per day to breast-fed and partially breast-fed infants. The easiest way to ensure that an infant will not get more than the recommended dose is to use a product supplied with a dropper that will give no more than 400 IU per dose. The AAP’s recommendations are provided hereExit Disclaimer.
Excessive amounts of Vitamin D can be harmful to infants, and may be characterized by nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences such as kidney damage.
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Wednesday, May 12, 2010
FDA: Serious Side Effects from Swallowing Topical Benadryl Product
/PRNewswire/ -- The U.S. Food and Drug Administration is warning consumers about potentially serious side effects from mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel, an over-the-counter (OTC) product that should only be used on the skin.
The FDA has received reports of serious side effects in people who have mistakenly swallowed the product. Some OTC Benadryl products are intended to be swallowed. However, Benadryl Extra Strength Itch Stopping Gel is only safe and effective when used, as directed, on the skin.. People swallowing the gel can ingest a dangerous amount of the active ingredient, diphenhydramine. Large doses of diphenhydramine can result in serious side effects such as unconsciousness, hallucinations, and confusion.
"Consumer confusion and incorrect product use are serious public health issues," said Carol Holquist, R.Ph., director of FDA's Division of Medication Error Prevention and Analysis. "FDA is advising consumers and pharmacies to store products for the skin separately from products that should be swallowed."
Many pharmacies and grocery stores sell diphenhydramine topical gels that look very similar in packaging to Benadryl Extra Strength Itch Stopping Gel. It is important that consumers also avoid swallowing these products.
To help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for use on the skin, the manufacturer, Johnson and Johnson, has taken the following actions:
-- Changed the product label to add a new, prominent statement "For Skin
Use Only."
-- Attached a sticker to the cap of the product that says "For Skin Use
Only."
-- Initiated consumer studies to better understand factors that may
contribute to consumers mistakenly swallowing Benadryl Extra Strength
Itch Stopping Gel.
The FDA encourages manufacturers of similar products to adopt similar changes to their labeling and packaging.
The repackaged product is currently stocked in retail stores. The FDA reminds consumers and health care professionals to always read the "Drug Facts" box to identify active ingredients, directions for use, and warnings before using any OTC drug product.
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The FDA has received reports of serious side effects in people who have mistakenly swallowed the product. Some OTC Benadryl products are intended to be swallowed. However, Benadryl Extra Strength Itch Stopping Gel is only safe and effective when used, as directed, on the skin.. People swallowing the gel can ingest a dangerous amount of the active ingredient, diphenhydramine. Large doses of diphenhydramine can result in serious side effects such as unconsciousness, hallucinations, and confusion.
"Consumer confusion and incorrect product use are serious public health issues," said Carol Holquist, R.Ph., director of FDA's Division of Medication Error Prevention and Analysis. "FDA is advising consumers and pharmacies to store products for the skin separately from products that should be swallowed."
Many pharmacies and grocery stores sell diphenhydramine topical gels that look very similar in packaging to Benadryl Extra Strength Itch Stopping Gel. It is important that consumers also avoid swallowing these products.
To help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for use on the skin, the manufacturer, Johnson and Johnson, has taken the following actions:
-- Changed the product label to add a new, prominent statement "For Skin
Use Only."
-- Attached a sticker to the cap of the product that says "For Skin Use
Only."
-- Initiated consumer studies to better understand factors that may
contribute to consumers mistakenly swallowing Benadryl Extra Strength
Itch Stopping Gel.
The FDA encourages manufacturers of similar products to adopt similar changes to their labeling and packaging.
The repackaged product is currently stocked in retail stores. The FDA reminds consumers and health care professionals to always read the "Drug Facts" box to identify active ingredients, directions for use, and warnings before using any OTC drug product.
-----
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