High-Dose Simvastatin Increases Rhabdomyolysis Risk, FDA Says

Cheryl A. Thompson

BETHESDA, MD 19 March 2010—Preliminary analyses by FDA of the primary data from a study of simvastatin dosages in patients with a prior myocardial infarction suggest that the 80-mg/day regimen increases the risk of rhabdomyolysis, a rare adverse event of all statins, the agency announced today.

The condition developed in about 0.02% of the 6031 patients taking 80 mg/day of simvastatin in the investigation known as SEARCH: Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine, according to FDA.

None of the 6033 patients taking 20 mg/day of simvastatin had rhabdomyolysis.

The highest dosage listed in the FDA-approved labeling for simvastatin products is 80 mg/day. Since 2005, the drug's labeling has warned of a dose-related risk of myopathy.

FDA described rhabdomyolysis as the most serious form of myopathy. Possible consequences of rhabdomyolysis include severe kidney damage, kidney failure, and sdeath.

The agency said it wants health care professionals to be aware that a simvastatin dosage of 80 mg/day potentially puts patients at higher risk of muscle injury over what their risk would be with lower dosages of simvastatin and possibly other statins.