FDA Recommends Reducing Dosage of Popular Cholesterol-Lowering Drug Simvastatin

Simvastatin is a prescription drug used to control elevated cholesterol.

Last week, the FDA recommended that doctor not start patients on an 80 mg dose of simvastatin – the highest approved dose of the drug — because of the risk of a condition known as myopathy, characterized by unexplained muscle weakness or pain.

The FDA further recommended that the 80 mg dose of simvastatin should only be used by patients who have been taking it for 12 months or longer without ill effect. New patients should be started at 40 mg, and if a doctor finds that patients taking 40 mg of simvastatin aren’t meeting their LDL cholesterol goal, the doctor should choose a different statin drug rather than raising the simvastatin dose to 80 mg.