Simvastatin to carry warning about myopathy

The cholesterol-lowering medication simvastatin will be required to carry a warning about the risk of muscle injury or myopathy, the FDA announced last week.

The warning is based on an FDA safety review finding that 80 mg, the highest approved dose of the drug, has been associated with an elevated risk of myopathy. The review, which included the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine and adverse event reports, showed that patients taking simvastatin, 80 mg daily, had an increased risk of muscle injury compared to patients taking lower doses of simvastatin or other statins. The risk of muscle injury is highest during the first year of treatment, is often the result of interactions with certain other medicines, and is frequently associated with a genetic predisposition for simvastatin-related muscle injury, according to an FDA news release.

According to the new label, simvastatin, 80 mg, should be used only in patients who have been taking that dose for 12 months or more and have not experienced any muscle toxicity. Patients who are unable to adequately lower their cholesterol on 40 mg of simvastatin should not be given an 80-mg dose. Instead, they should try an alternative treatment, the FDA said. The label also lists new contraindications and dose limitations for when simvastatin is taken with certain other medications that interact to increase the level of simvastatin in the body.

Simvastatin is sold under the brand name Zocor and as a single-ingredient generic product. It is also sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor.