The Food and Drug Administration warned Wednesday that a popular cholesterol-lowering drug should no longer be prescribed at its highest dosage to new patients because of concerns that it can cause muscle damage.
The drug is simvastatin and the unsafe dosage level is 80 milligrams. This dosage level can increase the risk for myopathy, which is a form of muscle damage.
Simvastatin is sold under the brand name Zocor, in addition to being sold as a generic product. It is also sold in combination with other drugs under the brand names Vytorin and Simcor.
The FDA recommendation is that doctors only continue prescribing the 80 mg dose to patients who have been taking it for at least a year without experiencing problems.
Additionally, simvastatin should not be taken with some other drugs, including some antibiotics, HIV drugs and anti-fungal medications, according to the FDA and Merck, which makes the drug.
In 2010, about 2.1 million patients in the United States were prescribed a product containing simvastatin at that dose, the agency said. About 12 percent of simvastatin users take that dose, according to Merck.