Right on the heels of a recent blog post regarding safety concerns over the diabetes drug Actos (pioglitazone), the U.S. Food and Drug Administration (FDA) made a huge announcement today about another diabetes medication in the same thiazolidinedione drug class--Avandia (rosiglitazone).
The FDA announced Avandia will be restricted to Type 2 diabetes patients who cannot control their diabetes with other medications.
This decision was in response to data that suggests patients taking Avandia may have an elevated risk of cardiovascular events. In a statement from Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research at the FDA, the evidence was "not robust or consistent" but there was not reliable evidence to refute concerns.
The European Medicines Agency, Europe's version of the FDA, has decided to stop marketing of the drug altogether.
The FDA decided not to remove Avandia from the U.S. market because of conflicting data on safety, the possibility it might be the only drug option for some patients to achieve glycemic control and because current patients may wish to continue taking the drug even after being informed of the risks.
The drug and maker, GlaxoSmithKline, will undergo stringent monitoring and will be directed to participate in a restricted access program. Patients who continue to use Avandia will be required to sign a consent acknowledging they understand the risks.
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