The Food and Drug Administration on Wednesday announced new safety restrictions on high-dose simvastatin, also known as Zocor, a cholesterol-lowering drug taken by an estimated 2.1 million Americans.
The agency said the 80-milligram dose caused a potentially severe muscle disease, called myopathy, especially in the first year of taking the medication.
No new patients should be put on the high dosage, the F.D.A. said, recommending that existing patients should continue only if they have used the drug for more than a year without experiencing muscle pains. Alternative statins may be safer, the agency said.
This surely will lead to a spate of product/medical liability lawsuits against the manufacturers of this drug.