Merck’s cholesterol-lowering drug Zocor (generic: simvastatin) has recently been linked to muscle damage, myopathy, rhabdomyolysis and kidney failure. The U.S. Food & Drug Administration (FDA) is recommending limiting the use of the highest approved dose of Zocor because of these potential side effects. Doctors and patients are being advised to carefully weigh the risks vs. benefits of taking Zocor before prescribing.
Please note, Schmidt & Clark, LLP is no longer accepting Zocor claims. If you feel that you may have a potential case, we urge you to locate another law firm adequately suited to handle your claim.
Zocor Lawsuit Update 6/7/12: Last week, a class action lawsuit was filed on behalf of Zocor users, alleging that the widely-prescribed cholesterol lowering drug was marketed without proper warnings about the risk of rhabdomyolysis and muscle injuries. The claim was filed on the same day as two other Zocor lawsuits were filed in federal court against Merck and four of its generic manufacturers. Click here to learn more.
Zocor Update 3/1/12: The U.S. Food & Drug Administration (FDA) issued a press release today informing healthcare professionals of updates to the prescribing information concerning adverse interactions between protease inhibitors and certain statin medications. When these two types of drugs are taken together, they may raise the blood levels of statins and increase the risk of a severe muscle injury known as myopathy. Click here to learn more.
Zocor Update 2/28/12: The U.S. Food & Drug Administration (FDA) issued a press release today stating that it will be requiring all statin drugs to carry a new warning about the increased risk of elevated blood sugar and possible transient memory and cognition problems. The label changes will apply to atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), lovastatin extended-release (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor). Click here to learn more.
Free Zocor Case Evaluation: If you or a loved one has been injured by Zocor, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
Manufactured and marketed by Merck & Co., Zocor is an FDA-approved prescription medication used to lower cholesterol and triglycerides (types of fat) in the blood. Zocor is in a group of drugs called HMG CoA reductase inhibitors that reduce levels of bad cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of “good” cholesterol (high-density lipoprotein, or HDL). In addition to being prescribed to treat high cholesterol, Zocor is also commonly used to lower the risk of stroke, heart attack and other complications in patients with diabetes, coronary heart disease and other risk factors.
In addition to Zocor, other potentially-dangerous medications from the statin class include:
Side Effects of Zocor
Despite its relative effectiveness at treating high cholesterol, high doses of Zocor have recently been linked to a number of potentially life-threatening side effects. Patients prescribed the 80 mg. dose of Zocor have an increased risk of developing:
- muscle damage
- kidney damage
- kidney failure
Myopathy is a muscular disease in which the muscle fibers do not function, resulting in severe muscular weakness. The primary defect of myopathy is within the muscle, as opposed to the nerves or elsewhere. Signs and symptoms of Zocor-induced myopathy include:
- muscle weakness
- tetany (involuntary contraction of the muscles)
In a clinical trial where 41,050 patients were treated with Zocor – the majority of which were treated for at least 4 years – the incidence of myopathy was approximately:
- 0.02% at 20 mg./day
- 0.08% at 40 mg./day
- 0.53% at 80 mg./day
Additionally, the FDA analyzed results of the SEARCH trial, which evaluated the number of cardiovascular events in 6,031 patients taking the 80 mg. dose of Zocor compared to 6,033 patients taking 20 mg. of Zocor. The cumulative results showed a significantly higher percentage of myopathy in the 80 mg. group.
Zocor Kidney Failure
Kidney failure (also commonly referred to as renal failure) is the sudden loss of the ability of the kidneys to remove waste and concentrate urine without losing electrolytes. The disease can occur from an acute situation, chronic problems or from medications like Zocor. Signs and symptoms of Zocor-induced kidney failure include:
- weight loss
- nocturnal urination
- more or less frequent urination habits
- bone damage
- muscle cramps
- abnormal heart rhythms
- muscle paralysis
- swelling of the legs, ankles, feet or hands
- low blood pressure
Rhabdomyolysis refers to the rapid breakdown of skeletal muscle, which results in the release of muscle fiber contents (myoglobin) into the blood stream. Myoglobin is harmful to the kidneys and often results in severe kidney damage and / or kidney failure. The diagnosis of rhabdomyolysis is typically identified with the help of blood tests and urinalysis. Signs and symptoms of Zocor-induced rhabdomyolysis depend on the severity of the condition, and may include:
- muscle pain
- tenderness, weakness or swelling of the affected muscles
- low blood pressure
- abnormal heart rate and rhythm
Zocor FDA Press Release
On June 8, 2011, the U.S. Food & Drug Administration (FDA) issued a press release recommending limiting the use of the highest approved dose of Zocor (simvastatin 80 mg) because of an increased risk of muscle damage. Patients taking the 80 mg dose have an increased risk of myopathy and other dangerous side effects compared to patients taking lower doses of the 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.”
The FDA is requiring changes to Zocor labels to include new information about drug interactions and dose limitations. The administration is recommending that Zocor 80 mg should not be started in new patients, including patients already taking lower doses of the drug.
Do I have a Zocor Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zocor lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.