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Label update for simvastatin

The US Food and Drug Administration has announced changes to the prescribing information for cholesterol medication, simvastatin, after the drug was linked to an elevated risk of muscle injury or myopathy

The US Food and Drug Administration (FDA) has announced changes to the prescribing information for cholesterol medication, simvastatin, after the drug was linked to an elevated risk of muscle injury or myopathy.

The updates will be made to the label of products containing the highest approved dose of simvastatin (80mg), including Zocor, marketed by Merck. Outside the US and Canada, Merck is known as MSD.

The FDA recommends simvastatin 80mg only be used in patients who have been taking the dose for at least year without muscle-related problems. The drug should not be prescribed to new patients. Further contraindications have also been added to the drug's information.

In 2010, about 2.1 million patients in the US were prescribed a product containing simvastatin 80mg.

"We encourage those who think these changes might affect them to talk to their doctor," said Dr Michael Rosenblatt, chief medical officer for Merck. "Patients should talk with their doctor before they stop taking any of their medicines. We are committed to communicating these changes to help physicians and their patients understand the updated recommendations for use of this important medicine."

9th June 2011

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