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.

3 Responses to “FDA and EMA Split on Fate of Avandia”

  1. Louis Krut, MB.ChB. MD says:

    There is a host of drugs available that allow us to effect control of diabetes in every tangible way that is currently attainable. There is absolutely no reason to leave yet another drug on the market which offers no measurable advantages to patients even if the risk of harm is small, at that risk is more than small. It is surely time to stop seeking to generate yet more data in the hope of shifting numbers in a way that at best cannot be other than inconsequential.

    Competing interests pertaining specifically to this post, comment, or both:

  2. james mcdermott, Electrical Engineering says:

    Sulfonylurias and Glitazones have been around for years and in my opinion are more effective when changing life styles choices and dietary management is encouraged and implemented . This has been known for as long as the drugs have been around but Pharmaceutical Companies ( i have no problem with them in general ) continue to skew data by using influence over common sense , perpetuate the pill taking solution . As Doctors become more busy and medications replace physical exams or follow up visits , the costs will rise with a comparative negligible benefit .

    Competing interests pertaining specifically to this post, comment, or both:

  3. Several months ago I took the decision to stop prescribing Avandia and have advised pts who are already on it to stop it. There are several very useful drugs in our arsenal to manage diabetes successfully without subjecting an already high risk population to further danger to have an adverse cardiovascular event. Not forgetting either that we still practice defensive medicine in America. Avandia’s effect in lowering triglycerides will be missed.