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FDA may halt sales of Avandia due to heart risk

WASHINGTON -- The Food and Drug Administration will ask outside specialists next week whether the diabetes drug Avandia should be pulled from the market over concerns of heart attack risk.

The FDA scheduled a Monday meeting to ask drug safety and diabetes experts to review GlaxoSmithKline's blockbuster drug after a medical journal article in May suggested it elevates heart attack risk by 43 percent in patients who take the drug.

The agency posted documents yesterday on its website that include its latest review of the drug.

The FDA is also expected to ask panelists whether any heart attack risks seen with Avandia are greater than those of rival diabetes treatments, which include Takeda Pharmaceutical's Actos and Merck & Co.'s Januvia.

The agency is not required to follow the recommendation of the panel of experts although it usually does. The company says its studies show that the drug is as safe as comparable treatments.

If the panel votes to keep Avandia on the market, as most analysts expect, the FDA will ask the group whether a so-called black box warning about heart attack risks or other restrictions should be added to the drug's label.

More than 6 million people worldwide have taken Avandia or a related drug, Avandamet, since it came on the market in 1999. Doctors use the pills to control blood sugar levels in patients with adult-onset diabetes.

In briefing documents posted online, Glaxo argued that "there is no consistent or systematic evidence" linking Avandia to increased risk of heart attack or death. However, the company recommends expanding the drug's label, which already includes a warning about heart failure.

Glaxo said it plans to add a warning that diabetics who already take insulin should not take Avandia.

The proposed warning is consistent with the FDA's review.

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