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News Articles >> Watchdog Group to FDA: Avandia Should B..
Watchdog Group to FDA: Avandia Should Be Removed From the Market
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| August 3, 2007. By Anne Borden |  RSS  Del.icio.us  Seed Newsvine  Facebook |
Washington, DC: Avandia should be removed from the U.S. market, according to testimony delivered by the consumer watchdog group Public Citizen before a Food and Drug Administration (FDA) advisory committee.
Unfortunately, the FDA has not heeded the call of Public Citizen and other advocacy groups. The advisory committee voted 22-1 in favor of allowing the drug to remain on the market. Critics of the agency are crying foul, and questioning the FDAs methods for determining the safety of medications currently on the market.
Adverse Reactions Reported from the Beginning
Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen testified before the panel that FDA adverse reaction reports have been filed since marketing began for the drug in 1999 through the end of last year.
The panel seemed to agree with Dr. Wolfe and others that adverse reactions were a serious problem. In a 20-3 vote, the panel agreed that Avandia was tied to "increased ischemic risk" such as congestive heart failure, and several suggested a strong "black box" warning for Avandia.
So it was a shock to observers that nearly all of the panel members voted to allow the drug to remain on the market. In the words of one analyst: "After days of testimony and discussion about health risks and reports of deaths, I assumed [Avandia] would be pulled, or at least that the vote would have been closer.
"Instead it was a landslide to keep it on the market. Why?"
Public Citizen's Report
Based on an analysis of existing studies on Avandia, researchers at Public Citizen found a 15.2 times higher adjusted rate of heart failure reported with Avandia than for the older diabetes drug Glucotrol.
"The evidence concerning the increased risk of ischemic heart disease including myocardial infarctions appears to justify the removal of this drug from the market," Dr. Wolfe testified.
Furthermore, the adjusted rate of liver toxicity with Avandia was a reported 9.5 times higher. It was 14.8 times higher for liver failure. "There were 46 reports of deaths from hepatic failure with Avandia," he stated.
Vision impairment, a major complication of diabetes, is also made worse by Avandia, Dr. Wolfe said. The adjusted reporting rate for macular edema -- a swelling in the retina -- was 35.3 times higher for Avandia than for Glucotrol.
Wolfe also discussed post-approval evidence of increased bone fractures in women and damage to patients' vision associated with the drug.
A "Double Standard"?
After delivering a detailed review of clinical evidence, Dr. Wolfe told the panel: "There is no evidence of any uniquely beneficial clinical outcome for Avandia and growing evidence of unique risks in multiple organ systems.
"If Avandia were up for approval today, based on what is now known, it would be summarily rejected. There should not be a double standard for removing it from the market."
Many critics have been wondering whether any benefits of Avandia truly outweigh the risks that were acknowledged during the panel's proceedings. Dr. Wolfe argued that the dangers associated with the drug are not present in older, safer diabetes medications, begging the question: is there any good medical reason to keep Avandia on the market?
Public Citizen, for one, doesn't think so. The advocacy group is currently preparing a petition to the FDA to ban Avandia.
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