A Pyrrhic Victory for Avandia: FDA Releases New Statement

On November 14 the FDA released a new warning about potential heart complications of Avandia. After reading the statement which can be found at

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01743.html

I was most impressed by the reserved tone the FDA used in describing the risk. Based on the types of articles already published by some leaders in the field of diabetes, it wouldn’t have been out of the question for the FDA to have Avandia withdrawn from the market. Instead the FDA chose to include the term “potential” when describing the risk of heart attack associated with using Avandia. The FDA also explains that there isn’t enough data at present to say that Avandia creates an increased risk of heart attack compared to other diabetes drugs and that further studies are necessary to clarify this.

Finally, the FDA adds that at present no diabetes drug is associated with a reduced risk of heart attack. In my opinion this is a slap at the makers of Actos (Takeda Pharmaceuticals) , the direct competitor of Avandia in the diabetes market. Takeda has recently been heavily promoting a single study which seems to indicate a potential heart benefit of their drug, Actos.

My overall impression is that this is a win for GSK, the makers of Avandia in that the warning is a lot milder than it might have been and that it moves to silence the makers of Actos who appear to be making the most of the negative publicity surrounding the Avandia controversy.

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