Legal News for Product Liability Attorneys. An increased risk of muscle injury was associated with using the 80 mg dosage of simvastatin, sold as Zocor.
Product liability attorney alerts- FDA warns consumers of muscle injury risks associated with simvastatin, a cholesterol-lowering drug.
West Palm Beach, FL—The U.S. Food and Drug Administration (FDA) http://www.fda has issued a formal warning of a potentially increased risk of muscle injury associated with consuming the highest approved dose of Zocor (simvastatin), a cholesterol-lowering drug. The consumer health safety alert was announced on Friday, March 19, 2010.
Simvastatin is sold as the single-ingredient medication in both the generic version and as Zocor. Combinations of simvastatin and ezetimibe (creating Vytorin), as well as simvastatin and niacin (creating Simcor), also pose increased risks to patients using higher dosages of the medications. The increased dangers linked with the cholesterol-lowering medication simvastatin were revealed through clinical trials, studies, and incident reports collected by the FDA. Medical information amassed by the SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine), which assessed serious cardiovascular and muscle injury incidents in patients taking 20 mg of simvastatin as opposed to the highest approved dosage of 80 mg, were also taken into account.
Although there are muscle injury (myopathy) hazards posed by the use of all types of statins, patients who are prescribed the 80 mg dosage of Zocor may be susceptible to an increased risk of myopathy, including rhabdomyolysis. Rhabdomyolysis is a critical form of muscle injury, which has the potential to cause serious kidney damage, kidney failure, and even fatality.
According to Deputy Director of FDA’s Division of Metabolism and Endocrinology Products (DMEP) Eric Colman, M.D, “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.”
Legal News Reporter: Sandra Quinlan- Legal News for Product Liability Lawyers.
