Consumer Group Calls For Statin Warning
August 21, 2001
Consumer advocacy group Public Citizen recently filed a petition with the Food and Drug Administration (FDA) demanding that the agency require stronger warnings on cholesterol lowering drugs known as "statins." The drugs are associated with potentially fatal muscle deterioration known as rhabdomyolysis. The organization wants labels to warn both doctors and patients of this deadly side effect.
The petition included statistics from FDA reports establishing that between October 1997 and December 2000 fifty-two people died in the United States from muscle damage related to statins. Eighty-one people have died since the 1987 introduction of statins in the United States. These figures do not include those injured and killed by Baycol, a statin that was recently recalled.
Public Citizen wants labels, known as "black box" warnings, to be placed on Zocor, Mevacor, Pravachol, Lipitor, and Lescol, detailing the risk of developing statin induced rhabdomyolysis. In addition, Public Citizen calls on statin drug manufacturers to send informational letters to physicians around the country explaining the risks and hazards of statin-related muscle damage. The group also wants the FDA to distribute a pamphlet with each prescription warning of the dangers associated with this class of drugs.
-- Article Courtesy of InjuryBoard.com
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