FDA to change cholesterol-lowering drug safety label

The changes to the label for simvastatin-containing medications are based on the FDA’s review of the results of the seven-year Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine clinical trial, other clinical trial data, and analyses of adverse events submitted to the FDA’s Adverse Event Reporting System.

The studies confirmed that patients taking simvastatin 80 mg daily had an increased risk of muscle injury compared to patients taking lower doses of simvastatin or other statin drugs.

The company concludes that risk of muscle injury is highest during the first year of treatment with the 80 mg dose of simvastatin, is often the result of interactions with certain other medicines, and is frequently associated with a genetic predisposition for simvastatin-related muscle injury.

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.

The FDA has revised the drug labels for simvastatin and Vytorin to include the new 80 mg dosing restrictions.

The agency also revised the labels for simvastatin, Vytorin and Simcor to include new dosing recommendations when these drugs are used with certain medications that interact to increase the level of simvastatin in the body, which can increase the risk for myopathy.

FDA Center for Drug Evaluation and Research Metabolism and Endocrinology Products deputy director Eric Colman said the FDA has completed its review of the safety of high-dose simvastatin and is making label changes to reduce the risk of statin-associated muscle injury.