Zocor (simvastatin) Myopathy and Rhabdomyolysis Risks
On June 8, 2011, the FDA announced that the cholesterol-lowering medications, Zocor (simvastatin) and Vytorin (ezetimibe plus simvastatin), are required to add new safety information to the products’ labeling alerting health care professionals and patients of the increased risk for myopathy (muscle injury) and its more serious form, rhabdomyolysis, associated with daily use of the 80 mg dose of simvastatin. Patients are at greatest risk for developing simvastatin-associated myopathy during their first year taking the medication. In addition, myopathy may be associated with taking simvastatin in combination with other medications and in some patients, a genetic predisposition may exist.
The FDA’s safety recommendations include: only those patients who have taken the daily dose of 80 mg simvastatin for more than a year without experiencing signs of muscle toxicity should be allowed to continue the 80 mg dose; doctors should not write new prescriptions for the 80 mg dose of simvastatin; and that new contraindications and dose limitations for simvastatin, when taken in combination with other medications, should be added to the label.
Zocor (simvastatin)
Zocor (simvastatin) belongs to a group of drugs called statins, which are prescribed to lower the amount of “bad cholesterol” (low-density lipoprotein cholesterol or LDL-C) in the blood. Simvastatin is marketed as Zocor (Merck & Co.); in combination with ezetimibe as Vytorin (Merck & Co./Schering Plough), and in combination with niacin as Simcor (Abbott Labs). Generic simvastatin is marketed by multiple generic manufacturers, including Teva Pharmaceuticals, Ranbaxy Laboratories, and Dr. Reddy’s Laboratories.
Symptoms and Diagnosis of Rhabdomyolysis (Rhabdo)
Rhabdomyolysis (or rhabdo for short) is a potentially life-threatening myopathy characterized by the rapid breakdown of skeletal muscle. As the muscle cells breakdown, cellular by-products, including a protein called myoglobin, are released into the bloodstream. Faced with excessive amounts of circulating myoglobin, the kidneys act to “filter out” the myoglobin putting the patient at risk for developing kidney injury, e.g., acute tubular necrosis; kidney failure; and death. Compartment Syndrome, characterized by swelling and increased pressure in the muscle compartments of the arms and legs, is another serious rhabdo complication. Compartment Syndrome can lead to muscle and nerve damage and tissue death.
While there are multiple risk factors, the association between statin use and myopathy, including rhabdomyolysis, is well documented.
According to the National Institutes of Health, NIH, rhabdo symptoms may include:
- Dark, red, or cola-colored urine
- Overall or general weakness
- Myalgia (muscle pain)
- Muscle tenderness
- Weakness of the effected muscles
- Additional rhabdomyolysis symptoms may include fatigue, joint pain, seizures, and unintentional weight gain.
Diagnosis of rhabdomyolysis can be confirmed by your doctor. In addition to documenting your rhabdo symptoms, your doctor can order blood and urine testing to look for:
- Increased CK (creatine kinase), also referred to as CPK (creatine phosphokinase),
- blood levels
- Positive serum myoglobin test
- Elevated levels of serum potassium
- Positive urine myoglobin test
- Additional urinalysis testing
The entire FDA Zocor/simvastatin safety update may be found by selecting Zocor Labeling Change.
Obtain a Free Zocor Lawsuit Case Evaluation
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