FDA’s warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of Zocor drug.
Simvastatin is sold as a single-ingredient generic medication and as the brand-name Zocor. It also is sold in combination with ezetimibe as Vytorin, and in combination with niacin as Simcor. FDA said that it will update the public as soon as the review of simvastatin is complete.
Reportedly, FDA’s review of new information on the risk of muscle injury is derived from clinical trials, observational studies, adverse event reports and prescription use data.
Additionally, the agency also is reviewing data from the Search (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) trial, which evaluated major cardiovascular events, in patients taking 80mg compared to 20mg of simvastatin. Search also included data on muscle injury in patients taking simvastatin.
Eric Colman, deputy director of division of metabolism and endocrinology products (DMEP) at FDA, said: “Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available. It’s important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy.”