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.
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