What’s Up with the FDA? Part 1

May 6th, 2011 by MorganDowney Leave a reply »

Faithful readers will recall that I spent two days last July at the FDA Endocrinologic and Metabolic Advisory Committee reviewing rosiglitizone (Trade name Avandia). Avandia, for type 2 diabetes has been interesting to follow not just because so many persons with obesity develop type 2 diabetes but because, due to its review coming amid the same Advisory Committee’s review of four obesity drugs, provided additional insights, especially into how the FDA evaluated safety concerns.

This became all the more interesting when the FDA decided to keep Avandia on the market, albeit with endhanced warning, but had Abbott Laboratories take sibutramine (trade name Meridia) off the market.  The point was made that Avandia had a number of fatal events, in its intended population while Meridia had no fatal events in a population which was specifically excluded on its label. Yet Meridia was spiked and Avandia was not.

Now comes a meta-analysis of Avandia’s class of drugs, called thiazolidinediones, which also includes pioglitazone, (Trade name Actos). The study, covering 16 studies with 810,000 patients found 170 excess myocardial infactions, 649 excess cases of heart failure and 431 excess deaths for every 100,000 patients who receive Avandia rather than Actos. Probably, this will not be enough for the FDA to take any stronger action against Avandia. See Comparative cardiovascular effects of thiazolidine… [BMJ. 2011] – PubMed result