Zocor
Zocor/Simvastatin Side Effect Lawsuit
Zocor/Simvastatin High Dosage Side Effects, Lawsuits | FDA Warns Increase Risk of Myopathy, Rhabdomyolysis, Muscle Injury, Skeletal Muscle Tissue Breakdown, Tenderness, Weakness, Unexplained Fatigue
United States Food and Drug Administration Press Releases about Simvastatin/Zocor Contraindications:
- CLICK HERE TO DOWNLOAD the FDA Simvastatin Contraindication Press Release
- CLICK HERE TO DOWNLOAD the FDA Simvastatin Safety Recommendation
- CLICK HERE TO DOWNLOAD the FDA Simvastatin Consumer Health Packet
The maximum dosage (80mg) of the cholesterol-lowering drug Zocor (simvastatin) can result in an increased risk of Myopathy, a severe type of muscle injury and Rhabdomyolysis during the first 12 months of treatment as stated in a recent report released June 8, 2011 by the FDA.
The defective drug attorneys at Parker Waichman LLP are currently evaluating potential lawsuits for individuals that have experience muscle injury, skeletal muscle tissue breakdown or any of the side effects associated with taking the maximum dosage of Zocor/Simvastatin. Patients taking the highest dosage of Zocor - 80 mg - during their first year of treatment face the greatest risk of muscle injury.
At its most severe, Zocor muscle injury can lead to rhabdomyolysis, a disorder that can damage the kidneys and lead to kidney failure and possibly death. Approximately 5 out of 100,000 individuals suffering from Zocor rhabdomyolysis side effects who were prescribed the 80mg dose had to be hospitalized.
If you took Zocor or another simvastatin product and were diagnosed with myopathy or rhabdomyolysis, our Zocor muscle injury lawyers want to hear from you today. You may be able to receive compensation for you pain and suffering by filing a Zocor muscle injury lawsuit. Our Zocor muscle injury lawyers are offering victims of this drug free lawsuit evaluations, so please contact us today or call us today at 1-800-LAW-INFO (1-800-529-4636) to protect you legal rights.
Zocor/Simvastatin Maximum Dosage Muscle Injury Warnings
Zocor is part of a class of drugs called statins that are used to treat high LDL (bad) cholesterol. Simvastatin is also sold in generic versions, and is an active ingredient in the combination drugs Vytorin and Simcor. Muscle injury has long been recognized as a possible statin side effect, and the labels of these medications all bear warnings regarding this risk. In 2010, the U.S. Food and Drug Administration (FDA) updated the labels of high-dose simvastatin to warn of an association with muscle injuries.
On June 8, 2011, the FDA added new warnings to the labels of Zocor and other simvastatin (cholesterol-lowering) drugs and recommended that patients not be prescribed the 80 mg dose during the first 12 months of treatment in order to mitigate the Zocor muscle injury risk. The new restrictions and warnings also apply to Vytorin and Simcor. In addition, the labels for simvastatin, Vytorin and Simcor were changed to include new dosing recommendations when these drugs are used with certain medications, such as blood pressure medicines amlodipine and diltiazem, which interact to increase the level of simvastatin in the body, which can increase the risk for myopathy.
The FDA's action was prompted by a seven-year study and patient reports that prove those taking the higher dosage of simvastatin have a greater risk of muscle injury than patients treated with lower doses or other statins. The agency said its review of a trial called the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) revealed 52 cases of myopathy occurring in the group of patients treated with 80 mg simvastatin versus one in the group treated with 20 mg. Twenty-two patients in the 80-mg group developed rhabdomyolysis, while none in the 20-mg group developed the disorder.
The risks for myopathy and rhabdomyolysis with simvastatin 80 mg were highest in the first 12 months of treatment, 5 per 1000 person-years and 2 per 1000 person-years, respectively, and decreased to 1 per 1000 person-years and 0.4 per 1000 person-years after that, the FDA said.
An analyses of the FDA's Adverse Event Reporting System (AERS) database also showed that the level of reporting of fatal rhabdomyolysis associated with the 80-mg dose of simvastatin has been higher in comparison with lower doses of simvastatin or lower doses of most other statins, the agency said.
Legal Help for Victims of Zocor Muscle Injuries
If you suffered from myopathy or rhabdomyolysis because of Zocor, you have valuable legal rights. To find out how our Zocor injury lawyers can help you receive compensation for your injuries, please fill out our online form or call 1-800-LAW-INFO (1-800-529-4636) today.
