June 09, 2011
SAFETY ALERT: FDA Recommends Limiting Use of Zocor (simvastatin) 80mgThe FDA has notified healthcare professionals that it is recommending limiting the use of Zocor (simvastatin; Merck) 80mg because of an increased risk of myopathy. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. The most serious form of myopathy, rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.
The FDA has revised the drug labels for simvastatin and Vytorin (ezetimibe/simvastatin; Merck) to include the new dosing restriction for the 80mg dose. The labeling for simvastatin, Vytorin, and Simcor (extended-release niacin/simvastatin; Abbott) were also revised to include new dosing recommendations when these drugs are used with certain medicines that interact with simvastatin and increase the level of simvastatin in the body. Increasing the levels of simvastatin in the body can increase the risk for myopathy. The FDA recommends that simvastatin 80mg not be started in new patients, including those already taking lower doses of the drug.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258384.htm.