On June 8, 2011, the U.S. Food & Drug Administration (FDA) warned the public and medical communities about the risk of myopathy, kidney damage and rhabdomyolysis associated with the cholesterol drug Zocor. Doctors and patients are being advised to carefully weigh the risks vs. benefits of taking Zocor before prescribing. The Defective Drug Lawyers at Schmidt & Clark, LLP are currently investigating potential lawsuits on behalf of individuals who have been diagnosed with any of these life-threatening medical conditions.
What is Zocor?
Manufactured and marketed by Merck & Co., Zocor (generic: simvastatin) is an FDA-approved cholesterol lowering medication that belongs to the statin family of drugs. Zocor is designed to work by lowering production of cholesterol in the body. It reduces low-density lipoprotein (LDL) – often referred to as bad cholesterol – and total cholesterol in the blood, which can prevent heart attacks, strokes and vascular disease. Zocor also increases high-density lipoprotein (HDL), or ‘good cholesterol.’ Raising HDL cholesterol levels – like lowering LDL cholesterol – may slow coronary artery disease. Yet despite its effectiveness at lowering cholesterol, Zocor has unfortunately been linked to kidney damage, myopathy, rhabdomyolysis and other serious side effects.
The highest approved dose of Zocor – 80 milligrams – has been shown to increase the risk of myopathy, which is a form of muscle damage. In full-blown myopathy, the muscle fibers no longer function correctly, which results in muscular weakness. The signs and symptoms of myopathy will vary depending on the type of disorder and cause, but in general will include:
Treatment for myopathy depends on the severity and condition of the disease. Options may include drug therapy, such as immunosuppressives, physical therapy, bracing to support weakened muscles, and surgery. For severe cases of Zocor-induced myopathy, supportive or symptomatic treatment may be the only beneficial course of action for treatment.
“The FDA has completed its review of the safety of high-dose simvastatin and is making label changes to reduce the risk of statin-associated muscle injury,” said Eric Colman, M.D., deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “We want to ensure that patients and health care professionals are aware of the new labeling changes to simvastatin, including the increased risk of myopathy when using the 80 mg dose of simvastatin.”
The most serious form of myopathy is called rhabdomyolysis, a condition that can damage the kidneys and lead to total kidney failure. Rhabdomyolysis results from a breakdown of muscle fibers and release of their contents into the bloodstream. Signs and symptoms of rhabdomyolysis may be hard to pinpoint because the course of the disease varies from patient to patient. Additionally, symptoms may occur in one area of the body or affect the entire body. The following are common signs and symptoms of rhabdomyolysis:
- painful, swollen, bruised, or tender areas of the body
- muscle weakness or trouble moving arms or legs
- general feeling of illness
- muscle weakness
- trouble moving the arms or legs
- general feeling of illness
- lack of consciousness
- dark colored urine
Rhabdomyolysis is a rare but extremely serious medical condition. Hospitalized rhabdomyolysis occurs in 4.9 people out of every 100,000 people exposed to the 80 mg. dose of simvastatin for one full year (the average incidence for hospitalized rhabdomyolysis for simvastatin is 4.4 people out of every 100,000 people).
“We believe that the 80-milligram dose should be taken off the market completely,” says Dr. Michael Carome, deputy director of the Health Research Group for Public Citizen. Carome notes that high doses don’t seem to be much more effective than lower doses. “But the more you take, the greater the risk,” he says.
Zocor Kidney Damage
In rhabdomyolysis, skeletal muscle begins to deteriorate rapidly, releasing myoglobin and other substances which are harmful to the kidneys. If left untreated, rhabdomyolysis can lead to kidney damage that can potentially result in acute kidney failure. When this occurs, the kidneys are no longer able to remove waste and concentrate urine without losing electrolytes. Symptoms of Zocor-induced kidney failure may include:
- bruising easily
- changes in mental state / mood
- decreased appetite
- decreased sensation in the hands or feet
- hand tremors
- high blood pressure
- metallic taste in the mouth
- persistent hiccups
- prolonged bleeding
- swelling of the ankle, foot or leg
- changes in urination patterns
Zocor FDA Warning
On June 8, 2011, the FDA announced that it was requiring new safety label changes for all medications containing simvastatin because the 80 milligram dose has been associated with the side effects listed above. The risk for myopathy, rhabdomyolysis and kidney injury was greatest during the first 12 months of use. FDA is recommending that 80 mg. doses of Zocor only be used in patients who have been taking it for longer than a year and have not experienced any muscle toxicity.
“The changes to the label for simvastatin-containing medications are based on the FDA’s review of the results of the seven-year Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine clinical trial, other clinical trial data, and analyses of adverse events submitted to the FDA’s Adverse Event Reporting System. All showed that patients taking simvastatin 80 mg daily had an increased risk of muscle injury compared to patients taking lower doses of simvastatin or other statin drugs. The risk of muscle injury is highest during the first year of treatment with the 80 mg dose of simvastatin, is often the result of interactions with certain other medicines, and is frequently associated with a genetic predisposition for simvastatin-related muscle injury.”