September 23rd, 2010
FDA and EMA Split on Fate of Avandia
The FDA and the European Medicines Agency announced separate and divergent decisions on the fate of rosiglitazone (Avandia) today.
On the one hand, the FDA announced that it would allow rosiglitazone to remain on the market, though only with severe restrictions on its use. Additionally, the FDA said it would require the drug’s manufacturer “to convene an independent group of scientists” to re-adjudicate the controversial RECORD trial. The FDA also placed the TIDE trial on “full clinical hold”. (Click here for more FDA documents.)
On the other hand, the European Medicines Agency announced it was recommending suspension of rosiglitazone and said the drug will no longer be available in Europe “within the next few months.”
Several hours after the announcements, the New England Journal of Medicine published a perspective on rosiglitazone by the FDA’s Janet Woodcock, Joshua Sharfstein, and Margaret Hamburg.