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The FDA Advisory Committee (AdComm for short) met today, July 30, 2007, and reviewed the safety data on rosiglitazone (Avandia). Despite dire warnings from one FDA staffer who advised pulling it from the market, the AdComm voted to allow it to remain on the market.The FDA published draft questions th...
Bill,
I feel that the Avandia should have a black box warning based on some of the patients that I have seen. How is the weight gain seen in these patients accounted for? Is it body fat or fluid? My greatest concern is that this is fluid retention. However, to its credit, those patients that have been on it have good to improved A1c's but the 20-30 pounds of weight gain bothers them. So is this inherent weight gain cause an increased risk for cardiac problems?