(01-04-10) U.S. Warns About Muscle Injuries With Simvastatin

The risk of myopathy is increased when the highest dose of simvastatin is used, according to a March 19statementissued by the U.S. Food and Drug Administration, which is conducting a safety review of the statin. The statement advises health care professionals to be aware of the potential increased risk of muscle injury associated with the 80 mg dose of simvastatin, the highest dose available, when compared with lower doses of simvastatin and ?possibly other statin drugs.? Although myopathy is a known side effect associated with all statins, ?today?s warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug,? the statement said. The FDA is reviewing data from clinical trials, observational studies, adverse event reports, and prescription use data, which includes the SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) trial, according to the statement. Preliminary data from SEARCH, which compared major cardiovascular events in more than 6,000 patients taking 80 mg or 20 mg of simvastatin for almost a seven-year period, found that 52 (0.9%) patients on the 80 mg dose developed myopathy, compared with one patient (0.02%) on the 20 mg dose. There were also 11 patients (0.02%) taking the 80 mg dose who developed rhabdomyolysis, but none in the low-dose group developed the condition. The statement also said that the FDA approved a labeling change for simvastatin earlier this month, based on the interim results of another ongoing clinical investigation, the Heart Protection Study 2. The revised label states that 80 mg of simvastatin should not be combined with ?cholesterol-modifying doses? of products that contain niacin (1 gram or more per day) in people of Chinese descent. The revised label also recommends caution when 40 mg or lower doses of simvastatin are used in combination with cholesterol-modifying doses of niacin-containing products in this population. The interim results of the study found that myopathy was more common among patients of Chinese descent (0.43%) who were taking 40 mg of simvastatin plus at least 1 g of a niacin-containing product daily, compared with patients who were not of Chinese descent (0.03%). Whether the risk is increased in other patients of Asian descent is not known, according to the FDA. In addition, the agency has also requested that the simvastatin label be changed to include the recommendation that doses of simvastatin above 40 mg per day should not be prescribed for patients who are also taking diltiazem, because this combination has also been associated with an increased risk of myopathy. Previous alerts about simvastatin issued by the FDA include one in 2008, about an increased risk of rhabdomyolysis when doses of simvastatin above 20 mg are administered with amiodarone. Other potential drug-drug interactions with simvastatin are listed in the label.

Source: univadis.it

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