FDA Panel Recommends Keeping Glaxo's Avandia On US Market

14th Jul 2010 21:10

By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON (Dow Jones)--A Food and Drug Administration panel voted Wednesday to recommend that GlaxoSmithKline PLC's (GSK) diabetes drug, Avandia, remain on the market despite concerns the product could raise the risk of heart attacks. Twenty members of the 33-member panel voted to keep Avandia on the market. Twelve people voted to remove the product from the market, and one person abstained. The panel had five choices on the Avandia marketing question. Three panel members voted to keep Avandia on the market as is, and seven people voted to strengthen warnings. Ten people voted to allow the product to remain on the market with additional warnings and some sort of restricted distribution plan or additional doctor and patient education. Earlier Wednesday, the panel said the data looking at Avandia was enough to raise "significant safety" concerns about the product. The panel voted 21 to 3 in favor of a question that asked whether clinical data showed that Avandia increased "ischemic CV events" relative to Actos, a similar drug made by Takeda Pharmaceutical Co (TKPYY, 4502.TO). Nine panel members said they weren't sure or couldn't make a finding one way or the other. Avandia's safety has been in question since a 2007 article in the New England Journal of Medicine by Cleveland Clinic cardiologist Steven Nissen showed it raised the risk of heart attacks by more than 40%. Nissen's study was an analysis of 42 existing studies, most of which lasted a year or less. GlaxoSmithKline has argued that long-term studies don't show such a risk. Heart failure from excess fluid retention has been a long-recognized problem with Avandia and Actos, and both products already carry the FDA's toughest boxed warning discussing that risk. The issue with Avandia is whether it raises the risk of heart attacks and other cardiovascular problems more than other diabetes treatments. Glaxo's New York-traded shares ended up about 1.8% at $36.35. -By Jennifer Corbett-Dooren, Dow Jones Newswires; 202-862-9294; [email protected] (END) Dow Jones Newswires July 14, 2010 16:10 ET (20:10 GMT)