FDA Announces Prescribing Information

The US Food and Drug Administration recently announced changes to the safety label for the 80 milligram (mg) dose of simvastatin in the use of cholesterol lowering. The changes are the result of the FDA's review of recent clinical trials including the seven-year Study for the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), and adverse events reported to the agency. All patients on the 80 mg simvastatin therapy showed a greater risk of myopathy compared to patients taking lower doses or even other statins.

The FDA recommends that 80 mg simvastatin only be used in patients who have been on the therapy for more than 12 months, or who have not experienced any muscle side effects. In addition, simvastatin at the 80 mg dose should not be prescribed for new patients. If a current patient is not getting to goal on the 40 mg dose, it is suggested a different drug be tried, instead of increasing the dosage. The FDA is also placing new restrictions and limitations on when the drug can be used in combination with certain other medications due to drug interactions.