Additional risk warning added to Avandia's label

November 16, 2007

New safety information added to rosiglitazone label

Information regarding the potential risk for myocardial infarction (MI) while taking rosiglitazone (Avandia, GlaxoSmithKline) has been added to the black box of the drug's product label. The added statement describes a meta-analysis of 42 clinical trials, which showed rosiglitazone was associated with an increased risk of myocardial ischemic events, including angina and MI. Three other studies that compared rosiglitazone with other oral antidiabetic agents or placebo have not confirmed the risk. According to the FDA, the 42 trials showing risk were shorter (mean duration six months; 14,237 total patients) while the three studies that did not confirm risk were longer (mean duration 41 months; 14,067 patients). Currently the agency said there is not enough evidence to show rosiglitazone is any more likely to cause MI or death than other oral Type 2 diabetes treatments. To this end, the FDA will require Glaxo to perform a new long-term study to evaluate the cardiovascular risk of the drug compared with other agents. The details of the trial have not been finalized; however, one of the comparator drugs will be pioglitazone (Actos, Takeda), the agency said. In addition, Glaxo is developing a Medication Guide for patients, highlighting the risks and benefits associated with rosiglitazone. The labeling change was recommended at a joint meeting of the FDA's Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees held in July. At the meeting, members voted 22 to 1 to recommend that rosiglitazone stay on the market, pending a review of additional data.

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