Safety Alerts & Recalls

What does this mean?

Muscle injury is a known side effect of all cholesterol-lowering statin medications. This alert is to inform you that taking high-dose simvastatin 80mg or taking simvastatin with certain drugs puts you at a higher risk for muscle injury.

If you are currently taking simvastatin, or the brand-name Zocor, Vytorin, or Simcor, you should:

1) Know that muscle injury is a side effect reported by patients taking any of the statin medications and rhabdomyolysis is a rare but serious form of muscle injury that may occur with any of the statins.

2) Continue taking simvastatin or the brand Zocor, Vytorin, or Simcor, unless told to stop by your doctor or other healthcare professional.

3) Review your medical history and current medications with your doctor or other healthcare professional to determine if you should continue using simvastatin or its brand-name product - especially if you are taking simvastatin 80 mg or one of the other drugs listed that limits your dose of simvastatin (such as Itraconazole, Ketoconazole, Erythromycin, Clarithromycin, Telithromycin, HIV protease inhibitors, Nefazodone, Gemfibrozil, Cyclosporine, Danazol, Amiodarone, Verapamil, Diltiazem).

4) Talk to your doctor or other healthcare professional about any questions or concerns you have about simvastatin or the information in this alert.

5) Call your doctor or other healthcare professional right away if you have muscle pain, tenderness or weakness, dark or red colored urine, or unexplained tiredness.

6) Report any side effects with simvastatin or the brands Zocor, Vytorin, or Simcor to the FDA's MedWatch program by phone 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: Ongoing Safety Review of High-Dose Simvastatin (Zocor) and Increased Risk of Muscle Injury

Today the U.S. Food and Drug Administration (FDA) described its ongoing safety review of the cholesterol-lowering medication simvastatin (Zocor). The FDA warned patients and healthcare providers about the potential for increased risk of muscle injury from high doses of simvastatin. Patients with simvastatin-related muscle injury, also known as myopathy, generally have symptoms of muscle pain, tenderness or weakness. The rare condition rhabdomyolysis is the most serious form of muscle injury and can lead to severe kidney damage, kidney failure, and sometimes death.

Although muscle injury is a known side effect with all cholesterol-lowering statin medications (such as Crestor, Mevacor, Lescol, Lipitor, Livalo, and Pravachol), today's FDA warning highlights the greater risk of developing muscle injury for patients when they are prescribed and use the high dose of simvastatin 80 mg. The risk of muscle injury is also increased when simvastatin is used with certain drugs.

The following limitations apply to ALL patients taking simvastatin.

- Do not use simvastatin with these medications: Itraconazole, Ketoconazole, Erythromycin, Clarithromycin, Telithromycin, HIV protease inhibitors, Nefazodone

- Do not use more than 10 mg of simvastatin with these medications: Gemfibrozil, Cyclosporine, Danazol

- Do not use more than 20 mg of simvastatin with these medications: Amiodarone, Verapamil

- Do not use more than 40 mg of simvastatin with this medication: Diltiazem

Simvastatin is sold as a single-ingredient generic medication and as the brand-name Zocor. It also is sold in combination with ezetimibe as Vytorin, and in combination with niacin as Simcor.

To learn more about this FDA on going safety review, please visit: more information here

Source: FDA
Publication Date: 2010-03-19
Last Updated: 2010-04-07

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