Two drug safety reviewers believe that the diabetes drug, Avandia, should be removed from the market because of the drug’s link to thousands of heart attacks. Documents were released Saturday, February 20, the same day a report released by the Senate Finance Committee, suggest that drug maker, GlaxoSmithKline PLC, knew or should have known of the drugs’ dangers. The report also criticized the less than watchful eye of the Food and Drug Administration that is supposed to oversee drug safety.
Senators Max Baucus and Charles Grassley and their report suggests GSK understood there were heart risks associated with Avandia for several years, even before a study from the Cleveland Clinic suggested a link. The report suggests that Glaxo even went so far as to intimidate independent physicians and downplayed findings that a competing drug might be superior in reducing heart risks.
The report was compiled from some 250,000 documents, some supplied by Glaxo, the FDA and whistleblowers. Glaxo rejected the report’s conclusion.
Avandia had sales of 43 billion in 2006, but sales dropped off to less than half of that amount in 2009.
An advisory panel will be assembled by the Food and Drug Administration to assess the risks of Avandia, GSK’s second biggest seller. FDA Commissioner Margaret Hamburg says she is looking forward to that report.
FDA Reviews Are Not Favorable
Within the FDA, two reviewers in 2008 issued a memo that concluded Avandia’s risks exceed those of rival drug Actos, made by Takeda Pharmaceuticals. David Graham and Cate Gelperin wrote that as many as 500 heart attacks and 300 cases of heart failure were associated with Avandia use every month. Dr. Graham had argued to the FDA, as far back as 2007, that sales of Avandia should be halted.
If you or a loved one takes Avandia, you should know that in 2007, the FDA decided it should carry an addition warning about an increased risk of heart attack associated with its use when compared to a placebo. And even though the Cleveland Clinic researchers published a report warning of the heart attack risks, an FDA panel in 2007 voted 22-1 to keep it on the market.
When there is any doubt, the benefit of the doubt goes to the drug company and not the patient it seems. If you or a loved one have been taking Avandia and want to know more, consult with a Florida product liability attorney with experience in defective drugs. #
Source Article: http://edition.cnn.com/2010/HEALTH/02/20/avandia.study/index.html?eref=ib_topstories
