July 30th FDA Meeting to Discuss Avandia
Updated July 2007: On July 30, 2007, the FDA will meet with GlaxoSmithKline to discuss the diabetes drug Avandia. The fact-gathering meeting is intended to thrash out the issue of increased heart attack risk for users from the drug.
The FDA has recently been criticized for letting risky drugs, like Merck’s Vioxx, slip through the regulatory system and onto the market. Now the FDA has to decide what to do with Avandia.
Less than two weeks before this meeting another analysis of Avandia has been published online by PharmaTimes. The study concluded that it found no evidence of any benefit of Avandia over other diabetes medications. Also, because of the many risks from the drug such as edema, fractures, increased risk of MI and heart attack, the authors of the study recommended that other medications be used if possible. Another study in the New England Journal of Medicine, conducted by Dr. Steven Nissen, stated that Avandia significantly increases the risk of heart attack.
Glaxo disagrees with the conclusions of Dr. Nissen’s study because he used results from previous studies instead of conducting his own. Glaxo has completed a large-scale study to measure Avandia’s potential heart attack risk and so far has found the risk to be “small, and comparable to other [diabetes] medicines.”
Because of the lack of conclusive evidence about Avandia’s heart attack risk, the FDA has chosen to have an information-gathering meeting. At this meeting Glaxo representatives will have to answer tough questions about their diabetes drug.