Safety Review Leads to New Restrictions on Simvastatin

FDA Updates Label With Restrictions, Contraindications

June 10, 2011 05:15 pm News Staff

The FDA is placing restrictions on the use of 80-milligram simvastatin and updating the labels of medications that contain the cholesterol-lowering medication after completing a safety review.

The agency announced in March 2010 that it was reviewing the drug's safety because 80-milligram simvastatin -- the highest available dose of the medication -- has been associated with an elevated risk of myopathy. The FDA now is recommending that the 80-milligram version of the drug only be used in patients who have been taking the high dose for 12 months or more and have not experienced muscle toxicity.

The agency also said the 80-milligram product should not be prescribed to new patients. Patients who do not meet their low-density lipoprotein, or LDL, cholesterol goal using 40-milligram simvastatin should be prescribed an alternative cholesterol medication rather than the higher dose of simvastatin, the FDA said.

In the June 8 safety announcement( about the 80-milligram product, the agency also announced new contraindications and dose limitations that affect the 10-, 20- and 40-milligram versions of simvastatin when taken with certain other medications.

More than 2 million U.S. patients were prescribed a medication containing 80-milligram simvastatin last year, according to the FDA. The following products are affected by the new restrictions and labeling changes:

  • simvastatin, which is marketed as Zocor;
  • simvastatin and ezetimibe, which is marketed as Vytorin; and
  • simvastatin and niacin, which is marketed as Simcor.

The FDA issued the following information for patients taking drugs that contain the 80-milligram version of simvastatin:

  • patients should not stop taking their medicine unless told to do so by their health care professional;
  • patients should review their medical history with their health care professional, their current dose of simvastatin and a list of their other current medications to determine if the medicines they are taking are appropriate;
  • patients should immediately contact their health care professional if they experience muscle pain, tenderness or weakness, dark- or red-colored urine, or unexplained tiredness; and
  • patients and physicians should report side effects from the use of simvastatin-containing medicines to the FDA's MedWatch program(

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