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Safety Review Leads to New Restrictions on Simvastatin
FDA Updates Label With Restrictions, Contraindications
By News Staff
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.
- 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.
FDA Warns of Risks Associated With Simvastatin
High Dose of Zocor, Use in Combination With Other Drugs Increase Risk of Muscle Injury