FDA recommends limiting use of simvastatin in 80-mg strength

SILVER SPRING, Md. — The Food and Drug Administration is seeking to limit the use of high doses of a drug for high cholesterol due to the risk of a muscle injury known as myopathy.

The FDA said it would recommend curtailing use of drugs containing 80 mg of simvastatin — the highest dosage approved by the FDA. The drug now is available as a generic, though Merck originally sold it under the brand name Zocor, and it’s one of the active ingredients of Merck’s Vytorin (simvastatin, ezetimibe and niacin). An estimated 2.1 million people were prescribed the 80-mg dose of the drug last year, according to the agency.

The agency said that only patients who have taken the drug for 12 months or longer without ill effect should take the 80-mg dose, and that prescribers should give it to patients only if they have been unable to adequately lower their cholesterol with the 40-mg dose.

“Our overall goal is to get doctors to not start patients on 80 mg of simvastatin,” FDA Division of Metabolism and Endocrinology Products deputy director Eric Colman said.

The FDA also said that all statins carry the risk of myopathy, characterized by unexplained weakness and pain in the muscles, but that 80-mg simvastatin carries especially high risk and that the muscle damage often results from interactions with other medications, while some patients are genetically predisposed to it. Other statins on the market include Pfizer’s Lipitor (atorvastatin) and AstraZeneca’s Crestor (rosuvastatin).

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