Safety Alerts & Recalls

What does this mean?

If you take amiodarone and also simvastatin or one of the simvastatin-containing products, it is a good idea to follow up with your doctor who can review your treatment and if needed, make adjustments to your medicines based on the FDA recommendations and your overall response to your medicines.

For most patients, the benefits of these medicines in lowering the risk of heart attacks and strokes continue to outweigh the risks, so you should continue taking your medicine. Do not stop taking your simvastatin-containing medicine or your amiodarone without consulting your doctor.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Revises Dose Limitation for Zocor (simvastatin) When Taken with Amiodarone

The U.S. Food and Drug Administration (FDA) is notifying the public that it has increased the dose limitation for the cholesterol-lowering drug simvastatin from 10 mg to 20 mg when it is prescribed with the heart drug amiodarone (Cordarone, Pacerone).

In June 2011, the FDA restricted the use of certain strengths of simvastatin in combination with other medicines to reduce the risk of muscle injury (myopathy). However, the FDA has now determined that the simvastatin dose limitation, when taken with amiodarone, was made in error and should be restored to 20 mg.

Simvastatin is available as a generic and under the brand name Zocor. Simvastatin is also available with other medicines in the combination tablets Juvisync, Simcor, and Vytorin.

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Source: FDA
Publication Date: 2011-12-15
Last Updated: 2012-02-28
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