FDA revises labels, recommends limiting simvastatin dosing

June 24, 2011

FDA announced changes to safety labels for simvastatin, Vytorin, and Simcor, including dosing recommendations and is advising physicians to limit the use of 80-mg simvastatin due to an increased risk of myopathy.

Physicians should limit the use of 80-mg simvastatin due to an increased risk of myopathy, according to an FDA consumer update and a corresponding news release. The agency also announced changes to safety labels for simvastatin, Vytorin, and Simcor to include 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 say.

The 80-mg dose is the highest approved dose for lowering cholesterol in patients; but FDA recommends this dose should only be used if a patient has taken the 80-mg dose for 12 months or longer with no adverse effects. If physicians find that 40 mg of simvastatin isn’t helping patients lower their cholesterol levels, FDA advises trying another statin rather than raising the dose to 80 mg, Amy Egan, MD, deputy director for safety in the FDA division said 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, deputy director of the Division of Metabolism and Endocrinology Products in 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,” he said in the agency’s news release.

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.

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