FDA Announces Safety Restrictions on Cholesterol Drug Zocor

The Food and Drug Administration announced new safety restrictions on high-dose simvastatin Wednesday, after reports that the cholesterol-lowering drug could cause a muscular disease called myopathy. The risks are particularly severe in the first year of taking the medication, also known as Zocor, the agency said.

No new patients should be put on a high dosage of the medication, the FDA warned. Patients currently taking the drug should only continue to do so if they have been on Zocor for over a year without muscle pains. Alternative statins may be safer, the health agency said. The drug’s manufacturer, Merck, advised that patients should speak with their doctors if they’re thinking about changing medications or dosages.

Zocor should not be taken with some other drugs, including some antibiotics, HIV drugs and anti-fungal medications. The new restrictions also apply to Vytorin, a combination drug sold by Merck and Schering-Plough that has some formulations in the 80-milligram dose, and Simcor, a combination pill sold by Abbott Laboratories.

The FDA approved 80-milligram Zocor in 1998, seven years after it approved lower doses of the drug. The drug became Merck’s top seller before the FDA issued a safety advisory on high-dose simvastatin in March 2010. Simvastatin has frequently been prescribed as a generic drug since the patent expired in 2006. According to drug data tracker IMS Health, Zocor was prescribed 94 million times in 2010.

For the most recent safety alert, the FDA cited a seven-year study and patient reports that proved patients taking higher doses of Zocor have a higher risk of muscle injury than those taking other statin drugs.

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