The U.S. Food and Drug Administration announced recently its updated drug safety recommendations for use of the drug, simvastatin (Zocor). The FDA now recommends limiting the use of the highest approved dose of the drug (simvastatin 80mg), due to the increased risk of muscle damage and muscle injury (myopathy).

In addition to the new restrictions surrounding limits on the drug’s dosage, the FDA is also requiring that changes be made to the simvastatin label, adding new contraindications and dose limitations for using the drug with certain medications.

It seems the cholesterol-lowering medication is currently the subject of the FDA’s latest drug safety communication, specifically intended to educate, inform and protect consumers. Furthermore, this recent announcement from the FDA reaches the public as a result of its ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury.


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