FDA Consumer Update: Limit Use of 80 mg Simvastatin

The United States Food and Drug Administration recommends that users of drugs containing 80 mg of simvastatin watch their intake of the drug, due to a risk of muscle injury.  80 mg is the highest approved dose of this cholesterol lowering statin.

The FDA stated that the dose should only be taken by patients who have been taking it for one year or more with no ill effect.

“Our overall goal is to get doctors to not start patients on 80 mg of simvastatin,” says Eric Colman, M.D., deputy director of FDA’s Division of Metabolism and Endocrinology Products.

The FDA is advising patients that are currently taking 40 mg of simvastatin and aren’t meeting their LDL cholesterol goal choose a different statin in place of raising their simvastatin dose to 80 mg, according to Amy Egan, M.D., deputy director for safety in the FDA division.

While statins are proven to be beneficial in lowering the risk of heart attacks and strokes, the drugs carry risk of myopathy, which is an injury characterized by unexplained muscle weakness of pain.

According to the FDA, the statin is sold under the brand name Zocor and as a single-ingredient generic drug. It is also sold in combination with ezetimibe as Vytorin, and niacin as Simcor.

The drug labels for simvastatin and Vytorin have been altered by the FDA to include the new restrictions for the 80 mg dose, according to Egan.

The FDA does not recommend for patients to stop taking their medication without consulting their doctor.  However, they do recommend that you contact your health care professional if you have:

  • Muscle pain
  • Tender or weak muscles
  • Dark or red-colored urine
  • Unexplained fatigue
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