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FDA: High-Dose Simvastatin Given With Certain Drugs Increases Risk of Myopathy ROCKVILLE, Md -- March 19, 2010 -- Based on review of data from a large clinical trial and data from other sources, the US Food and Drug Administration (FDA) is informing the public about an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, simvastatin (Zocor) 80 mg, compared with patients taking lower doses of simvastatin and possibly other drugs in the statin class. The clinical trial data being reviewed is from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. The agency is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury (see Data Summary below). Myopathy is a known side effect with all statin medications. The higher the dose of statin used, the greater the risk of developing myopathy. The risk of myopathy is also increased when simvastatin, especially at the higher doses, is used with certain drugs. The most serious form of myopathy is called rhabdomyolysis. Additional Information for Healthcare Professionals FDA recommends that healthcare professionals should: · Understand that rhabdomyolysis is a rare adverse event reported with all statins. · Be aware of the potential increased risk of muscle injury with the 80 mg dose of simvastatin compared with lower doses of simvastatin and possibly other statin drugs. · Review patients’ medical history and medications to determine if simvastatin is clinically appropriate. · Discuss with patients the benefits and risks, including the risk of myopathy and rhabdomyolysis, of simvastatin therapy. · Be aware of potential drug-drug interactions with simvastatin. · Report any adverse events associated with the use of simvastatin to the FDA. Do not use simvastatin with these medications: · Itraconazole · Ketoconazole · Erythromycin · Clarithromycin · Telithromycin · HIV protease inhibitors · Nefazodone Do not use more than 10mg of simvastatin with these medications: · Gemfibrozil · Cyclosporine · Danazol Do not use more than 20mg of simvastatin with these medications: · Amiodarone · Verapamil Do not use more than 40mg of simvastatin with this medication: · Diltiazem Data Summary The SEARCH trial evaluated over 6.7 years the number of major cardiovascular events (myocardial infarction [MI], revascularisation, and cardiovascular death) in 6031 patients taking 80 mg of simvastatin compared with 6033 patients taking 20 mg of simvastatin. All patients in the study had previously had a MI. Preliminary SEARCH trial results revealed that more patients in the simvastatin 80 mg group developed myopathy compared with patients in the simvastatin 20 mg group (52 [0.9%] cases compared with 1 case [0.02%]). Preliminary analyses of the primary data suggest that 11 (0.02%) of the patients in the simvastatin 80 mg group developed rhabdomyolysis compared wiht no patients in the simvastatin 20 mg group. In March 2010, FDA approved a labeling revision for simvastatin based on interim results from an ongoing clinical trial -- the Heart Protection Study 2 (HPS2). The revised label states that patients of Chinese descent should not receive simvastatin 80 mg with cholesterol-modifying doses of niacin-containing products. Further, the revised label recommends caution when such patients are treated with simvastatin 40 mg or less in combination with cholesterol-modifying doses of niacin-containing products. The interim HPS2 results showed that the incidence of myopathy was higher in patients of Chinese descent (0.43%) compared with patients not of Chinese descent (0.03%) taking 40 mg simvastatin plus cholesterol-modifying doses (>=1 g/day) of a niacin-containing product. It is not known if the increased risk for myopathy observed in these patients applies to other patients of Asian descent. Moreover, the FDA has requested that the sponsor of simvastatin to change the product labeling to instruct healthcare professionals to avoid prescribing simvastatin doses greater than 40 mg daily when patients are taking the medication diltiazem, due to an increased risk for myopathy. A 2010 review of prescription drug use data conducted by FDA found that, despite dose limitations and drug-drug interaction precautions included in the simvastatin drug label, patients are continuing to be prescribed higher doses of simvastatin with other medications that are known to increase the risk for rhabdomyolysis. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version