FDA to ask if Avandia should stay on market
The U.S. Food and Drug Administration will ask outside advisers if the diabetes drug Avandia should be taken off the market or remain on sale with new warnings or limits, a summary released on Thursday July 26th said. It also said the agency has "considerable concern" about data that shows a signal of possible heart attack risks with Avandia. The various data currently available has "somewhat inconsistent findings.” If the advisers decide Avandia should stay on the market, the FDA will ask about whether it would be prudent in adding a strong "black box" warning or limiting use to certain patients. The FDA released the summary among more than 400 pages of documents prepared for the advisory panel review of the drug's heart risks. The maker of Avandia said in documents that its data showed no higher heart attack risk with Avandia than other oral diabetes drugs. The FDA usually follows advisory panel recommendations.
