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FDA issues changes to simvastatin safety labeling
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Due to an association between 80 mg simvastatin and an increased risk of myopathy, the FDA has announced safety label changes that will restrict use of what is currently the highest approved dose of the drug.
This association, according to a press release, was most prominent during the initial 12 months of use and as a result the FDA is recommending no new patients be prescribed 80 mg simvastatin (Zocor, Merck). Only patients who have been taking the dose for a year or more are recommended to continue taking it, provided they have not experienced any muscle toxicity. Additionally, the release also states that the labeling will feature new contraindications and dose limitations for when simvastatin is taken with certain other medications.
These changes were the result of the FDA’s review of the seven-year Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) clinical trial, as well as other trial data and analyses that were submitted to the agency’s Adverse Event Reporting System. The data indicated that patients taking 80 mg simvastatin daily had an increased risk of myopathy vs. those who took lower doses of the drug or other statin drugs, with the highest risk found during the first year of treatment. The data also suggested that this adverse event was commonly the result of interactions with certain other medicines and was frequently linked with a genetic predisposition for simvastatin-related muscle injury.
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