The Buzz: FDA advisory committees recommend removing rosiglitazone
Citation: AAFP News Now, 7/20/2010
Summary: Members of two FDA advisory committees have expressed concerns over the safety of rosiglitazone (Avandia) and have recommended removing the medication from the list of approved drugs. While investigation into the safety of rosiglitazone has been ongoing since 2007, two recent studies from JAMA and the Archives of Internal Medicine
reported significant elevation in CV risk associated with its use. Of note, GlaxoSmithKline, the maker of Avandia, has said that it will record a $2.36 billion legal charge in the second quarter of fiscal year 2010 for settlements related to rosiglitazone.
Commentary: While FDA has yet to make a decision, we should consider getting our patients off rosiglitazone, and certainly not write new prescriptions for it. Pioglitazone (Actos) is considered safer than rosiglitazone, though it should be considered only in patients refractory to or intolerant of first- and second-line therapies.
By: Spencer Blackman MD
UPDATE (9/25/2010): Rosiglitazone has been pulled from the European market, and will only be offered to US patients in whom "every other" diabetes medication has been tried.
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