2011 Most-Read Articles by Primary Care Physicians

Carol Peckham


December 09, 2011

In This Article

The Top Read Article in Primary Care Is...

1. FDA Restricts Use of Simvastatin 80 mg

In early June 2011, the US Food and Drug Administration (FDA) issued a drug safety communication on the 80-mg dose of simvastatin because of an increased risk for muscle toxicity. "Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug," the agency stated.

It advised physicians to limit using the 80-mg dose unless the patient had already been taking the drug for 12 months and there is no evidence of myopathy. In addition, the FDA requested that additional changes be made to the drug's label. The label changes include the new dosing recommendations as well as warnings not to use the drug with various medications, including itraconazole (Sporanox), ketoconazole (Nizoral®), posaconazole (Noxafil®), erythromycin, clarithromycin, telithromycin (Ketek®), HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, and danazol. In addition, the 10-mg dose should not be exceeded in patients taking amiodarone, verapamil, and diltiazem, and the 20-mg dose should not be exceeded with amlodipine (Norvasc®) and ranolazine (Ranexa®).

As a result, there was concern that physicians would not be comfortable escalating to branded statins because of resistance from managed care and sometimes the necessity for prior authorization. In addition, it was thought that many patients would also be distressed by the added cost of a more expensive statin. The availability of generic atorvastatin in November should help address these issues for many patients.

For commentary on this issue see Switching From Simvastatin 80 mg: How to Shop for Statins and Simvastatin 80 mg: If You Can't Go Lower, Go Elsewhere


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