On June 8, 2011, the U.S. Food and Drug Administration (FDA) announced changes to the safety label for the cholesterol-lowering medication simvastatin (Brand name: Zocor). The FDA is recommending that the highest approved dose of simvastatin (80 mg) should not be prescribed to new patients. It should only be used in patients who have been taking this dose for one year or more and have not experienced any muscle toxicity. This new recommendation is due to the fact that patients taking simvastatin 80 mg daily had an increased risk of muscle injury compared to patients taking lower doses of simvastatin, particularly during the first year of use.
Cardiac disease is the leading cause of death in Connecticut. In 2006 alone, heart disease and stroke cost the residents of Connecticut an estimated $4.7 billion dollars in medical expenses and lost productivity. In 2010, about 2.1 million people in the United States were prescribed a product containing simvastatin 80 mg.
Simvastatin is used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of “bad cholesterol” (low-density lipoprotein cholesterol or LDL) and triglycerides in the blood and to increase the amount of "good cholesterol" (high-density lipoprotein or HDL) in the blood. High levels of "bad cholesterol" (LDL) increase your risk of heart attack, stroke and cardiovascular death. Simvastatin works by slowing the production of cholesterol in the body so that the cholesterol cannot build-up on the walls of the arteries. This build-up could potentially block blood flow to the heart, brain, and other parts of the body.
“The FDA [wants] to ensure that patients and health care professionals are aware of the new labeling changes to simvastatin, including the increased risk of myopathy when using the 80 mg dose of simvastatin,” said Eric Colman, M.D., of the FDA’s Center for Drug Evaluation and Research (CDER).
The risk of muscle injury is highest during the first year of treatment with the 80 mg dose of simvastatin and is often the result of interactions with certain other medicines. The risk is also frequently associated with a genetic predisposition for simvastatin-related muscle injury. There is an increased risk for myopathy in Chinese patients taking simvastatin 40 mg co-administered with niacin-containing products (≥1 g/day niacin). The risk for myopathy is dose-related -- the higher the dose, the higher the risk. Thus, caution should be used when treating Chinese patients with simvastatin doses above 20 mg/day and when co-adminstering with niacin-containing products (e.g., Simcor, Niacor, Niaspan, Advicor). It is unknown if the risk for myopathy with simvastatin 80 mg observed in Chinese patients applies to other Asian patients.
Simvastatin is sold under the brand-name Zocor and as a single-ingredient generic product. It is also sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor.
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