High dose of simvastatin poses muscle injury risk

Patients taking high doses of simvastatin (Zocor) face an increased risk of myopathy, according to a new warning from the FDA.

Although muscle injury is a known side effect with all statins, the warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients who take the 80-mg dose of this drug, the FDA said. Rhabdomyolysis is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and sometimes death.

The FDA's data on simvastatin were derived from observational studies, adverse event reports, prescription use data, and clinical trials, including the SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) trial, which evaluated patients taking 80 mg compared to 20 mg of simvastatin.

In addition to being sold as a single-ingredient generic medication and as the brand name Zocor, simvastatin is sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor.