Merck responds to FDA warning of simvastatin use

WHITEHOUSE STATION, N.J. Merck & Co. has responded to a warning by the Food and Drug Administration about potential safety risks in patients taking the highest dose of a drug used to lower cholesterol.

“Simvastatin, when used as a supplement to a healthy diet, can help reduce LDL cholesterol and reduce the risk of death form cardiovascular disease in patients at high risk of coronary events,” Merck chief medical officer Michael Rosenblatt said in a statement. “We support the FDA’s recommendation that patients continue their medication as prescribed by their physicians and that patients speak to their physician if they have symptoms or questions.”

The FDA warned patients and healthcare professionals Friday of the risk of muscle injury, also known as myopathy, in patients taking simvastatin in the 80-mg strength. Though muscle injury is a side effect common among all statins, the agency said patients taking higher doses of simvastatin run a higher risk. Of particular concern is the risk of rhabdomyolysis, a severe form of myopathy that can lead to kidney damage, kidney failure and sometimes death.

Merck originally marketed the drug under the brand name Zocor, though it now is available as a generic and is included as an active ingredient in several drugs, including Merck’s Vytorin (ezetimibe and simvastatin) and Simcor (niacin and simvastatin), marketed by Abbott and Solvay Pharmaceuticals. Vytorin is available with 80 mg of simvastatin, though Simcor is only available with 20 mg.