June 8th, 2011

FDA Recommends Limiting Use of High-Dose Simvastatin

The FDA today recommended significant limitations in the use of high-dose (80 mg) simvastatin because of the increased risk for myopathy. The FDA said the 80-mg dose should be used only in people who have been taking the high dose for at least one year and have had no evidence of myopathy. The high dose should not be started in new patients, including those already taking lower doses of the drug.

The FDA also said that the risk for myopathy is higher in the first year of treatment with simvastatin, is “often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy.” Hospitalization for rhabdomyolysis, the most serious form of myopathy, occurs in 4.9 people per 100,000 taking simvastatin for one full year, compared with an average rate of  4.4 per 100,000 taking statins in general.

The labels for drugs containing simvastatin, including Simcor and Vytorin, have been revised to include the new dosing restrictions, the FDA said. The agency advised healthcare professionals to switch patients who do not meet their cholesterol goal on 40-mg simvastatin to alternative treatments that provide a greater cholesterol-lowering effect.


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