The FDA has published new warnings regarding the use of simvastatin (Zocor). The new warnings are based on information that says those who are taking high-dose simvastatin (80mg dose) are at high risk for muscle injury, called myopathy, or a more serious and potentially fatal condition called rhabdomyolysis. FDA recommends to NOT take the 80mg dose, unless the person has been on it for at least one year in the absence of any evidence of muscle damage. If you are taking 80mg of simvastatin you should consult your physician. The other information in the warning involves LOWER DOSES of simvastatin when used in combination with other drugs, such as amlodipine (Norvasc), verapamil (Calan), diltiazem (Cardizem), amiodarone (Pacerone), among others. In those taking any of these drugs, the simvastatin dose is recommended to not exceed either 10 or 20mg, depending upon the drug. You can refer to the detailed information at the links below.Other drugs are contraindicated with simvastatin, meaning the combination should not be used together, regardless of dose. Some of these are: Gemfibrozil (Lopid), clarithromycin (Biaxin), itraconazole (Sporanox), ketoconazole (Nizoral), among others.
Myopathy is damage to the large muscles of the body that results in weakness, pain and/or tenderness. A more serious form of myopathy is rhabdomyolysis, which can lead to kidney damage and can be fatal. Any muscle pain, weakness or tenderness should be reported to your physician when taking simvastatin, or any statin since this adverse effect is a “class effect” of statins, meaning it can happen with any drug similar to simvastatin. Other statins are: atorvastatin (Lipitor), rosuvastatin (Crestor), lovastatin (Mevacor), pravastatin (Pravachol), fluvastatin (Lescol). FDA says this constellation of signs/symptoms should cause you to call your physician:
- Muscle pain, tenderness or weakness
- Dark or red-colored urine
- Unexplained fatigue