FDA slaps stronger black box warnings on Avandia

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Avandia is manufactured by GlaxoSmithKline  

Based on order of the FDA, GlaxoSmithKline (GSK), the manufacturer of the diabetes drug Avandia (rosiglitazone), has agreed to add new information to its existing boxed warning in the drug's labeling about potential increased risk of heart attack.

According to the FDA, patients with Type 2 diabetes who have underlying heart disease or who are at high risk of heart attack, should talk with their healthcare provider about the revised warnings. The agency advises healthcare providers to closely monitor patients who take Avandia for cardiovascular risks.

“FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings," according to Janet Woodcock, MD, FDA's chief medical officer and acting director of the Center for Drug Evaluation and Research.

In response, Ronald Krall, MD, GSK chief medical officer said that “Avandia remains a valuable medicine for most patients with Type 2 diabetes, and when used according to the labeling, has a well described and appropriate safety and effectiveness profile.” He added that “we will continue to work with the FDA to conduct more studies about the safety and benefits of our medicine.”

The agency based its decision on a meta-analysis of 42 clinical studies with mean duration of six months and 14,237 total patients, most of which compared Avandia to placebo. The results found Avandia to be associated with an increased risk of myocardial ischemic events, such as angina or heart attacks. Three other studies with mean duration of 41 months and 14,067 patients, comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded the risk. The FDA stated that if the studies are taken in “their entirety, the available data on the risk of myocardial ischemia are inconclusive.”

The Philadelphia-based pharmaceutical company also reported that, based on the new FDA recommendation, Avandia also is “not recommended—though not contraindicated—for use with patients who are taking insulin or nitrates.”