The Food and Drug Administration (FDA) on Wednesday restricted the use of high doses of the cholesterol-lowering drug simvastatin, which is sold in generic forms and under the brand names Zocor and Vytorin, because of concerns over muscle problems associated with the drug.
The agency recommends that no new patients start taking the highest dose, 80 mg, of the medication. However, those who are already safely taking that dose may continue to do so.
Statins, which lower cholesterol by inhibiting its production in the liver, are among the most commonly prescribed drugs in the U.S. Recent studies have shown that the medications can lower the risk of having a heart attack or dying from heart disease, but the drugs have also been linked to serious side effects.
The statin Baycol (cerivastatin) was recalled in 2001 after users reported elevated rates of muscle injury similar to the ones that led the FDA to restrict use of simvastatin. Concerns about simvastatin and its potential to cause muscle-weakening, known as myopathy, emerged last March when the FDA issued warnings about the risk.
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