June 8, 2011, 12:00:00PM. By Heidi Turner

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Washington, DC: The US Food and Drug Administration (FDA) has announced a change in the safety label for simvastatin (sold under the brand-name Zocor) because high-dose simvastatin has been linked to an increased risk of myopathy. The FDA recommends that 80 mg simvastatin, the highest dose approved by the FDA, only be used in patients who have already taken the dose for 12 months or more and have not developed muscle toxicity. Furthermore, the 80 mg simvastatin dose should not be prescribed to new patients.

Simvastatin is used to reduce the amount of bad cholesterol in the patient's blood. The FDA made its recommendations based on the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine clinical trial, which showed that patients taking 80 mg simvastatin daily had an increased risk of muscle injury. The risk is highest during the first 12 months of treatment with high-dose simvastatin and has been linked to interactions between simvastatin and other medications.

Simvastatin is sold under the brand-name Zocor. When combined with ezetimibe, it is sold as Vytorin. When combined with niacin, it is sold as Simcor. Both Zocor and Vytorin will carry the new dose restrictions.

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