Washington, DC: The Food and Drug Adminisration (FDA) notified healthcare professionals that it is recommending limiting the use of the highest approved dose of Zocor (Simvastatin), the cholesterol-lowering medication (80 mg), 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.
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).
Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor. For more information visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258384.htm
Legal Help
If you or a loved one has suffered illness or an adverse health event in this case, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on Jun-9-11 |
|
