FDA recommends recall of Avandia diabetes drug due to heart-related deaths
Millions of diabetics have been prescribed Avandia, which is sold by GlaxoSmithKline PLC, since it came on the market in 1999.
However, in May 2007, Avandia was linked to a 43 percent greater risk of heart attack and death in a scientific analysis published by the New England Journal of Medicine.
Upon the release of the 2007 study, GlaxoSmithKline downplayed the report and encouraged continued use of Avandia. Dr. Lawson McCartney, who led Glaxo’s diabetes drug development, said, “We remain very confident in the safety and of course in the efficacy of Avandia as an important diabetic medicine.”
But a piece in today’s New York Times says hundreds of people taking Avandia needlessly suffer heart attacks and heart failure every month, according to confidential Food and Drug Administration (FDA) reports obtained by the newspaper, recommending the drug be removed from the market.
The reports say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia damages the heart.
Avandia, whose generic name is rosiglitazone, is intended to treat Type 2 diabetes. It was linked to 304 deaths during the third quarter of 2009.
In cases such as this, where a drug maker refuses to pull a potentially fatal medication off the market, doesn’t the FDA have the authority to force a recall? Not necessarily. The FDA has authority to force a “black box warning” be placed on the drug, but does not have explicit power to force a company to remove the drug from the market, in the interest of free commerce. As long as the risks and benefits of a drug are fully disclosed to a patient and the patient voluntarily consents to its use, the FDA has no power to interfere in that patient’s treatment.
Article link: FDA recommends recall of Avandia
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