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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Showing posts with label heart. Show all posts
Showing posts with label heart. Show all posts
Monday, February 28, 2011
Wednesday, February 23, 2011
FDA warns against certain uses of asthma drug terbutaline for preterm labor
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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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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Saturday, November 20, 2010
Darvon and Darvocet: Risks Outweigh the Benefits
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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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Wednesday, January 14, 2009
Co-Payment Increases Result in Gaps in Veterans' Prescription Usage
TT Note: It just doesn't seem right that our men and women who fought for our country should have to choose whether or not to take medicine.
/PRNewswire-USNewswire/ -- Fewer veterans filled their prescriptions for cholesterol-lowering drugs after an increase in co-payment costs for prescription drugs, researchers report in Circulation: Journal of the American Heart Association.
In February 2002, the Veterans Administration (VA) increased prescription co-payments from $2 to $7 per 30-day drug supply.
To determine the impact of the co-payment increase on cholesterol-lowering medication adherence, researchers examined the electronic records of 5,604 veterans treated at the Philadelphia Veterans Administration (VA) Medical Center from November 1999 to April 2004.
They compared veterans in the all co-payment group and the some co-payment group with veterans who were exempt from making prescription drug co-payments. The all co-payment group paid co-pays for all drugs and the some co-payment group paid co-pays only for drugs for non-service connected health problems with out-of-pocket expenses capped at $840 per year.
Researchers analyzed the differences in cholesterol-lowering medication adherence during the 24 months before and 24 months after the institution of co-payments. Evidence of veterans having cholesterol-lowering medication 80 percent or more of the time were considered adherent.
Researchers found:
-- The number of patients who had medications available for more than 80
percent of the time declined by more than 19 percent in both the all
co-payment group and the some co-payment group. In comparison,
veterans exempt from co-payments, used as controls in the study, had a
decline of 12 percent.
-- The odds of having a continuous gap without medications for more than
90 days was three times higher among patients in the all co-payment
group and twice as high in patients in the some co-payment group when
compared to the exempt group.
"The increase in co-payments adversely impacted lipid-lowering medication adherence among veterans," said Jalpa A. Doshi, Ph.D., lead author of the study and research assistant professor of medicine at the University of Pennsylvania School of Medicine. "Of even greater concern is our finding on the similar adverse effect of the co-payment increase in veterans who are at higher risk for coronary artery disease taking the medications for primary or secondary prevention."
Statins and other cholesterol-lowering drugs have been shown to reduce the risk of future coronary events and cardiovascular mortality in patients at high risk, Doshi said.
"It is concerning to see that the increase in co-payments adversely affected the use of these usually long-term medications, especially since the prevalence of heart disease is higher in the VA population than in the general population," Doshi said. "These weren't just short gaps interspersed between lipid-lowering medication refills, but continuous gaps for 90 days or more."
The study did not look at the possible increase in use of medical care due to the lack of cholesterol-lowering drugs. Other studies have shown that not taking medications for chronic diseases increases healthcare costs.
"Policymakers need to realize that the one-size-fits-all approach in designing cost-sharing policies can adversely impact high-risk patient groups," Doshi said. "This seemingly small increase from $2 to $7 more than tripled the out-of-pocket costs for veterans, who were more likely to have a lower income than the patients in the private sector."
The VA should at least consider charging lower co-payments for generic drugs than for the brand-name prescription drugs, Doshi said. "Right now the VA charges a flat co-payment for a 30-day prescription, whether it is generic or a brand-name drug. This is particularly relevant in the case of lipid-lowering drugs such as statins, wherein two brand drugs became available as generics in 2006 and are available at significantly lower prices."
She said a more-promising approach is a "value-based insurance design" method that would link co-payments to the patient's need with lower co-payments for drugs with higher expected therapeutic benefit and higher co-payments for drugs with lower therapeutic benefit.
The co-payment was increased from $7 to $8 in 2006, and with present budget constraints, it's likely that the co-payment will be further increased, Doshi said.
The VA Center for Health Equity, Research and Promotion (CHERP), American Heart Association Pharmaceutical Roundtable Award, Commonwealth of Pennsylvania, the National Institute of Aging and the Penn Institute on Aging funded the study.
Co-authors are: Jingsan Zhu, M.B.A.; Bruce Lee, M.D., M.B.A.; Stephen Kimmel, M.D., M.S.C.E.; and Kevin Volpp, M.D., Ph.D. Individual author disclosures are available on the manuscript.
Statements and conclusions of study authors that are published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association's policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals, foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.americanheart.org/corporatefunding.
-----
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/PRNewswire-USNewswire/ -- Fewer veterans filled their prescriptions for cholesterol-lowering drugs after an increase in co-payment costs for prescription drugs, researchers report in Circulation: Journal of the American Heart Association.
In February 2002, the Veterans Administration (VA) increased prescription co-payments from $2 to $7 per 30-day drug supply.
To determine the impact of the co-payment increase on cholesterol-lowering medication adherence, researchers examined the electronic records of 5,604 veterans treated at the Philadelphia Veterans Administration (VA) Medical Center from November 1999 to April 2004.
They compared veterans in the all co-payment group and the some co-payment group with veterans who were exempt from making prescription drug co-payments. The all co-payment group paid co-pays for all drugs and the some co-payment group paid co-pays only for drugs for non-service connected health problems with out-of-pocket expenses capped at $840 per year.
Researchers analyzed the differences in cholesterol-lowering medication adherence during the 24 months before and 24 months after the institution of co-payments. Evidence of veterans having cholesterol-lowering medication 80 percent or more of the time were considered adherent.
Researchers found:
-- The number of patients who had medications available for more than 80
percent of the time declined by more than 19 percent in both the all
co-payment group and the some co-payment group. In comparison,
veterans exempt from co-payments, used as controls in the study, had a
decline of 12 percent.
-- The odds of having a continuous gap without medications for more than
90 days was three times higher among patients in the all co-payment
group and twice as high in patients in the some co-payment group when
compared to the exempt group.
"The increase in co-payments adversely impacted lipid-lowering medication adherence among veterans," said Jalpa A. Doshi, Ph.D., lead author of the study and research assistant professor of medicine at the University of Pennsylvania School of Medicine. "Of even greater concern is our finding on the similar adverse effect of the co-payment increase in veterans who are at higher risk for coronary artery disease taking the medications for primary or secondary prevention."
Statins and other cholesterol-lowering drugs have been shown to reduce the risk of future coronary events and cardiovascular mortality in patients at high risk, Doshi said.
"It is concerning to see that the increase in co-payments adversely affected the use of these usually long-term medications, especially since the prevalence of heart disease is higher in the VA population than in the general population," Doshi said. "These weren't just short gaps interspersed between lipid-lowering medication refills, but continuous gaps for 90 days or more."
The study did not look at the possible increase in use of medical care due to the lack of cholesterol-lowering drugs. Other studies have shown that not taking medications for chronic diseases increases healthcare costs.
"Policymakers need to realize that the one-size-fits-all approach in designing cost-sharing policies can adversely impact high-risk patient groups," Doshi said. "This seemingly small increase from $2 to $7 more than tripled the out-of-pocket costs for veterans, who were more likely to have a lower income than the patients in the private sector."
The VA should at least consider charging lower co-payments for generic drugs than for the brand-name prescription drugs, Doshi said. "Right now the VA charges a flat co-payment for a 30-day prescription, whether it is generic or a brand-name drug. This is particularly relevant in the case of lipid-lowering drugs such as statins, wherein two brand drugs became available as generics in 2006 and are available at significantly lower prices."
She said a more-promising approach is a "value-based insurance design" method that would link co-payments to the patient's need with lower co-payments for drugs with higher expected therapeutic benefit and higher co-payments for drugs with lower therapeutic benefit.
The co-payment was increased from $7 to $8 in 2006, and with present budget constraints, it's likely that the co-payment will be further increased, Doshi said.
The VA Center for Health Equity, Research and Promotion (CHERP), American Heart Association Pharmaceutical Roundtable Award, Commonwealth of Pennsylvania, the National Institute of Aging and the Penn Institute on Aging funded the study.
Co-authors are: Jingsan Zhu, M.B.A.; Bruce Lee, M.D., M.B.A.; Stephen Kimmel, M.D., M.S.C.E.; and Kevin Volpp, M.D., Ph.D. Individual author disclosures are available on the manuscript.
Statements and conclusions of study authors that are published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association's policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals, foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.americanheart.org/corporatefunding.
-----
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