FDA asks experts: Should Avandia stay or go?
Date posted: Fri Jul 9 14:41:14 EDT 2010 (Reuters Health)By Lisa Richwine |  |  |
WASHINGTON (Reuters) - U.S. government advisers will consider a range of options for GlaxoSmithKline Plc’s diabetes drug Avandia, including whether the medicine should be pulled from the market over heart risks, according to documents prepared for a meeting next week. The Food and Drug Administration will ask the expert committee, that meets Tuesday and Wednesday, to weigh other possibilities that would allow Avandia sales to continue. They include restricting the drug’s use, beefing up warnings or removing a strong heart-attack warning added in 2007. European regulators said on Friday they were launching a new probe into the safety of Avandia, adding to pressure on the medicine. The FDA and its expert panel must pore over a mass of studies that have various strengths and weaknesses and provide conflicting findings about the heart risk. Some FDA staff have pushed for the drug to come off the market. "There is not complete unanimity within the FDA about the interpretation of these data," Dr. Janet Woodcock, head of the FDA’s drugs center, told reporters on Thursday. The advisory panel’s recommendation will be considered by the FDA, although the agency usually follows the advice of its expert panels. Avandia remains widely used, but controversy has dogged the drug since 2007 when Cleveland Clinic researchers linked the pill to a higher heart-attack risk. An advisory panel that year agreed the data suggested Avandia may increase the chances of a heart attack for some patients but said the medicine should remain an option. At next week’s meeting, the FDA will ask the committee if Avandia raises heart-attack risk for Type 2 diabetics compared to other medicines, including Takeda Pharmaceutical Co’s rival pill Actos. Glaxo says the overall data shows Avandia does not increase the overall risk of heart attack, stroke or death and it is the only oral anti-diabetes drug that has been shown to control blood sugar for up to five years.
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