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Dr. David Graham, a medical officer in the Food and Drug Administration's Office of Surveillance and Epidemiology, said today that the Type 2 diabetes treatment drug Avandia should be pulled from the market in light of the cardiovascular risks it presents.

Panel to Make Recommendation to FDA

Graham was speaking to a joint panel of experts convened by the FDA to consider whether the controversial drug should be restricted to some patients, or branded with a more prominent and severe warning, or removed from the market altogether. The experts, from both within and outside the FDA, are expected to make a recommendation regarding Avandia to the FDA.

Prior Debate about Avandia's Safety

About one million people in America are being treated with Avandia to control their blood sugar. The drug increases the body's sensitivity to insulin. The issue of whether Avandia also makes patients more at risk for heart attack, stroke, and other heart-related events has been debated in the medical literature and in meetings of scientists and government officials.

The FDA's Graham state unequivocally that Avandia does pose a greater risk of cardiovascular events, and that in light of the fact that the drug doesn't offer any unique short-term benefits to diabetics, the drug should be removed from the U.S. market.

Drug Maker Disagrees

Avandia's maker, the pharmaceutical giant GlaxoSmithKline, disputes the heart risk. Glaxo's senior vice president and chief medical officer, Dr. Ronald Krall, said at today's meeting that "The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence rosiglitazone [Avandia] is different from any other oral antidiabetes agents."

FDA Will Probably Follow Panel's Recommendation

The FDA is not required to follow the recommendation of an advisory committee such as the panel convened today, but it usually does — indicating that if the panel recommends it, the FDA may well begin the process to have Avandia removed from the market in the U.S. Other diabetes treatment drugs are widely available to take its place, including Actos, which has not been shown to have any cardiovascular risks.

(Source: Associated Press)

Has Avandia treatment caused a serious side effect for you or your family member? Contact a qualified Avandia attorney to discuss your options.