The FDA has issued a warning that the commonly used cholesterol medication simvistatin, (also known as Zocor, Vytorin, and Simcor), increases the risk of severe muscle and kidney damage more than previously thought. These medications, known as statins, have a long, well known history of increasing a patient’s risk of muscle damage by a condition called rhabdomyolysis that can lead to kidney failure and death.
The research behind the warning suggests that the risk of muscle injury is dose dependant, the higher the dose, the higher the risk. Patients taking the highest approved dose of 80mg had 50 times higher the risk than patients taking 20mg dose. Also linked with higher rates of risk of rhabdomyolysis was combining even small doses of simvistatin with other cardiovascular medications. Commonly, patients treated for cardiovascular disease are on multiple medications so it is common to combine a cholesterol medication with other medications. Many different medications were tested, which, when combined were linked to increased risk. These include the blood pressure medication diltiazem (marketed as Cardizem, Cartia, Dilacor, Diltia, and Tiazac); anti-arrhythmia drug amiodarone; and verapamil (marketed as Calan, Covera, isoptin, and Verelan), used for arrhythmia, blood pressure, headaches and migraines.
The FDA also warned that patients taking cyclosporine, Danazol, and Gemfibrozil should not take more than 10 mg simvistatin. Further, any person taking HIV protease inhibitors, Clarithromycin, Erythromycin, Itraconazole, Ketoconazole, Nefazodone, or Telithromycin should never take simvistatin.
Dr. Kerry Ferguson