FDA releases warning about cholesterol-lowering drug dose
Posted July 29, 2011
Raleigh, N.C. — A cholesterol-lowering drug dose prescribed to 2.1 million Americans last year may cause life-threatening complications, according to the U.S. Food and Drug Administration.
Now, the FDA is recommending that people limit their use of the highest dose of Simvastatin, marketed as Zocor.
As a generic medication, Zocor is more affordable for patients. Many of them take the highest dose, 80 milligrams, which is the dose the FDA has noticed is leading to more patients with side effects and adverse reactions, like severe muscle disease.
“It can be associated with fever. It could be associated with renal failure, acute renal failure,” said Dr. John Kelly, a cardiologist at WakeMed. “It can be fatal.”
The FDA now recommends the 80 milligram dose should only be used for patients who've been on that amount for 12 months or more without evidence of muscle injury. No new patients should be prescribed 80 milligrams. New labeling will include new medications that should not be taken with Zocor.
WRAL Health Team physician Dr. Allen Mask says people currently taking an 80 milligram dose of Zocor should not stop taking the medication until they consult their doctor. People experiencing any unusual symptoms should seek medical care immediately.