Possible Causes for Kidney Failure: Public Citizen Calls For Statin Warnings
August 13, 2001
Due to Bayer AG's withdrawal of its popular cholesterol-lowering drug Baycol, the consumer advocacy group Public Citizen recently demanded that the Food and Drug Administration (FDA) require more significant warning labels on all statins, a popular class of cholesterol drugs. Baycol is linked to at least 31 deaths in the United States.
Statins are prescribed to help lower cholesterol by blocking a specific liver enzyme that produces the substance. Currently there are five statins other than Baycol on the market. These include Mevacor (lovastatin), Pravachol (pravastatin), Zocor (simvastatin), Lescol (fluvastatin) and Lipitor (atorvastatin). Bayer removed Baycol due to its association with rhabdomyolysis, a disease that destroys muscle cells, releasing them into the blood stream. The disease can be fatal as it sometimes leads to kidney failure. Public Citizen claims that statins are responsible for an additional 50 deaths in the United States.
Currently, statin labels warn patients to contact their doctors if they experience any muscle soreness. To strengthen the warnings, Public Citizen is pushing for a "black box" warning label that will emphasize the drugs' potential adverse side effects. The group is also asking for the distribution of a medical guide with each statin prescription.
Bristol-Myers Squibb, manufacturer of Pravachol, said that the black box warning label is unnecessary because its drug has a strong safety record. According to FDA officials, the agency has no plans to review the safety of statins. However, a European advisory panel has convened to investigate the safety of the popular class of drugs.
-- Article Courtesy of InjuryBoard.com
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