ARTICLE | Regulation

FDA's Avandia problem

FDA faces Avandia decision without clear guidance from its 2nd advisory panel

July 19, 2010 7:00 AM UTC

FDA officials walked out of an advisory panel meeting on Avandia rosiglitazone last Wednesday evening with the same problem they came in with on Tuesday morning: how to handle a drug that has been accused but not firmly convicted of causing an increase in cardiovascular events in a population that has a very high rate of heart attacks and strokes.

The committee split into three almost equal groups that recommended mild, moderate and extreme regulatory actions: 10 members voted to keep Avandia on the market with existing or updated labeling; 10 advised adding additional limits on its use, such as restricting prescribing to certain physicians or requiring special physician or patient education; and 12 wanted FDA to compel GlaxoSmithKline plc to withdraw the drug from the U.S. market...