ZOCOR (Simvastatin) WARNING

Notice


[Posted 06/08/2011] ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) [Zocor] because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. 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, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal. FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines.



BACKGROUND: The new changes to the drug labels for simvastatin-containing medicines are based on FDA's review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency's March 2010 Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).



RECOMMENDATION: Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.


What other information should I know?


Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your response to simvastatin.



Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.



It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.





American Society of Health-System Pharmacists, Disclaimer




National Center for Biotechnology Information, U.S. National Library of Medicine


8600 Rockville Pike, Bethesda MD, 20894 USA