Sunday, June 03, 2012

Avandia and Cardiac Risks Evaluated by Advisory Committee

By Dr. Bill Quick, Health Pro Monday, July 05, 2010

 

Will the FDA advise the manufacturer to take Avandia off the market? It's actually a two-step process: the FDA Advisory Committee will review the data, and make a recommendation to the FDA. The FDA usually follows the advice of AdComms, but is not obliged to do so. The FDA could pull the drug, or ask the manufacturer to pull it, or allow it to stay on the market with even more restrictions than at present, or perhaps to remain on the market with no further restrictions on its prescribing.

 

I think the answer this year is clearer than in 2007: Avandia is a drug that has outlived its usefulness. With the availability of what seems to be a less-risky drug in the same class, and with many new diabetes drugs in other classes that weren't available in 2007, it's time for Avandia to join Rezulin as another failed thiazolidinedione, and become a historical curiosity rather than a marketed drug.

 

 

 

 

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By Dr. Bill Quick, Health Pro— Last Modified: 05/03/11, First Published: 07/05/10