High-Dose Simvastatin May Increase Risk for Muscle Injury, FDA Warns

Patients who are taking the highest approved dose of the cholesterol-lowering drug simvastatin (Zocor) may face increased risk for muscle injury compared with those taking lower doses or "possibly" other statins, the FDA warned on Friday.


Reviewing preliminary data from one clinical trial, the agency found that muscle injury, including rhabdomyolysis, was more common among patients on the 80-mg dose of simvastatin versus a 20-mg dose (0.9% vs. 0.02%).
As part of an ongoing safety review of the drug, the FDA is also examining data from other clinical trials, observational studies, and adverse event reports.

FDA MedWatch alert (Free)
FDA safety communication (Free)
Zocor prescribing information (Free PDF)
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Dato' Dr. Ismail Yaacob
Medical Director/Consultant Physician
Kedah Medical Centre