FDA revises labels, recommends simvastatin dosing limit

Physicians should limit the use of 80-mg simvastatin due to an increased risk of myopathy, according to a recent FDA consumer update and a corresponding news release. The agency also announced changes to safety labels for simvastatin, Vytorin, and Simcor that will require inclusion of dosing recommendations when these drugs are used with medicines that can increase the level of simvastatin in the body.

The FDA recommendation follows a review of the results of the 7-year Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine clinical trial, other clinical trial data, and an analysis of data from the agency’s Adverse Event Reporting System, the statements said.

The 80-mg dose is the highest approved dose for lowering cholesterol in patients, but FDA recommends that this dose be used only if a patient has taken the 80-mg dose for 12 months or longer with no adverse effects. If physicians find that a 40-mg dose of simvastatin isn’t helping patients lower their cholesterol levels, FDA advises that another statin be used, rather than an 80-mg dose of simvastatin, said Amy Egan, MD, deputy director for safety in the FDA division, in the consumer update.

“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,” said Eric Colman, MD, in the agency’s news release. Colman is deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “We want to ensure that patients and healthcare professionals are aware of the new labeling changes to simvastatin, including the increased risk of myopathy when using the 80-mg dose of simvastatin.”