Labels of all statins now warn of the risk of rhabdomyolysis, a relatively rare condition that causes the breakdown of muscle tissue. But PCHRG wants a “black box” warning at the top of the package insert. Black box warnings typically are reserved for drugs with unusually severe side effects. Drugs carrying black box warnings are unlikely to be granted over-the-counter status. In 2000, two leading drug companies unsuccessfully applied to have their cholesterol-reducing drugs reclassified as OTC. Statins are very popular because of their effectiveness in reducing the risk of heart attack and stroke and because of their safety.
Tougher warnings for cholesterol?
Public Citizen’s Health Research Group, a consumer advocacy organization, asked FDA to highlight the health hazard warning on statins, the most popular cholesterol-lowering drugs in the United States used by 12 million people.
Oct 31, 2001
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