FDA Alerts for Zocor®

Because of the possible harmful effects of the cholesterol-lowering drug Zocor® (simvastatin) when taken at the 80 mg/day level, the U.S. Food and Drug Administration (FDA) has been studying these side effects and has released a number of safety announcements regarding the drug over the last several years.

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

FDA Alert: 80 mg of Zocor®

Currently, the most important information the FDA wants doctors and their patients to know about Zocor® (simvastatin) is that the highest single dose (80 mg/day) should be used only by patients who have been taking the medication for over a year and have had no serious side effects.

In addition, patients new to Zocor® should not be prescribed the 80 mg dose nor should patients already on the drug at a lower dose have the dose raised to 80 mg/day.

The reason for the concern is that the high dose of the drug has been found to cause myopathy or muscle pain in some patients and the much more serious condition, rhabdomyolysis, in others.

Rhabdomyolysis is a progression of myopathy to the point where broken down muscle tissue releases a substance called myoglobin into the bloodstream. The myoglobin is broken down further into toxic substances that can block the kidneys, leading to kidney disease, kidney failure, and even death.

The SEARCH Study

The federal agency has been reviewing the data from numerous studies and clinical trials. A clinical trial known as SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) compared patients taking the highest dosage of Zocor® or 80 mg daily with patients taking lower doses of the drug or other drugs in the class of drugs called statins.

All the patients in the SEARCH trial previously had a heart attack. The data showed that more patients in the simvastatin 80 mg group developed myopathy than the patients in the 20 mg simvastatin group:

  • 80 mg simvastatin group — 52 cases of myopathy
  • 20 mg simvastatin group — 1 case of myopathy

Warnings of Drug Interactions

In addition to the data summary presented by the FDA, the agency warned that certain drugs should not be used by patients taking simvastatin. Despite previous warnings to that effect, the FDA, in a 2010 review of prescription drug use data, found that patients were continuing to use dangerous combinations of the drugs that increased the risk for rhabdomyolysis.

The FDA warned that simvastatin should not be used with:

  • Itraconazole
  • Ketoconazole
  • Erythromycin
  • Clarithromycin
  • Telithromycin
  • HIV protease inhibitors
  • Nefazodone

No more than 10 mg of simvastatin should be used with:

  • Gemfibrozil
  • Cyclosporine
  • Danazol

No more than 20 mg of simvastatin should be used with:

  • Amiodarone
  • Verapamil

And, no more than 40 mg of simvastatin should be used with Diltiazem.

Contact Our Zocor® Attorneys Today

If you or a loved one has used simvastatin (Zocor®) and had problems with muscle damage, you should contact an experienced Zocor® attorney regarding this problem. To find out if you are eligible for compensation, please contact our attorneys for a free review of your case.

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