Zocor® (Simvastatin) Side Effects
If you or someone you love has suffered a serious side effect of Zocor®, you might be eligible for compensation. To learn more, contact our Zocor® side effect attorneys for a free review of your case.
Update about the Risks of 80mg Zocor®
The U.S. Food and Drug Administration (FDA) issued a safety announcement in June 2011 warning that 80 mg daily of Zocor® is an unsafe dosage and that new patients should not be started on a dose that high.
Only patients who have tolerated the medication at the 80 mg level for a year or more without any damaging side effects to the muscles should remain on the drug at that dose. The FDA warns that new patients should not be started on the 80 mg dose.
The FDA also warned that certain drugs which increased the amount of Zocor® retained in the body also should not be used in combination with Zocor®. In addition, certain patients who have a genetic predisposition to the toxic effects of Zocor® should not take the drug.
Because of these findings, the FDA is altering the drug label to reflect this new information
"Our overall goal is to get doctors to not start patients on 80 mg of simvastatin," said Eric Colman, M.D., deputy director of the FDA's Division of Metabolism and Endocrinology Products.
Possible Side Effects of Zocor®
Zocor®, like any medication, has side effects. Some of these side effects are more serious than others. The medication is a prescription drug to lower "bad" or LDL (low-density lipoprotein) cholesterol in the blood along with a proper diet and exercise. It also is meant to lower the risk of heart attack, stroke and death due to cardiovascular disease.
The most common and less serious side effects of Zocor® include:
- Upper respiratory infections
- Mild stomach pain
The more serious side effects occur less often and include:
Myopathy is a muscle disorder characterized by unexplained pain in the muscles. Rhabdomyolysis is a more serious condition progressing from myopathy and muscle pain to muscle tissue breakdown which can lead to kidney damage and death.
Rhabdomyolysis is a more serious condition that occurs when muscle exposed to some trauma or injury (including drugs) breaks down and releases myoglobin (the contents of muscle fibers) into the bloodstream. Myoglobin is further broken down into other substances, some of which may be harmful.
Myoglobin may block some structures of the kidneys, leading to acute tubular necrosis or kidney failure and death. The kidney contains these essential tubular structures that die after exposure to myoglobin.
In controlled clinical studies conducted before the drug was allowed on the market, 2,423 patients were studied with an average length of follow-up of about 18 months. The most common adverse reactions leading to dropping out of the studies were gastrointestinal disorders (0.5 percent), muscle ache (0.1 percent) and joint pain (0.1 percent).
In a clinical trial involving 12,064 patients with a history of heart attack, the incidence of myopathy in patients taking 80 mg of Zocor® daily was compared to the incidence of patients taking 20 mg a day. The results showed that:
- Patients on 80 mg/day had a 0.9percent incidence of myopathy
- Patients on 20 mg/day had a 0.2 percent incidence of myopathy
The incidence of rhabdomyolysis in patients taking 80 mg/day was about 0.4 percent compared to a 0.0 percent incidence in patients taking 20 mg/day.
Zocor®'s medication label warns that approximately 1 percent of patients taking Zocor® in clinical trials showed elevated liver enzymes over time. If you have active liver disease or your liver enzymes remain elevated after repeated tests for the substances, you should not take Zocor®.
If you or someone you love has suffered a serious side effect of Zocor® such as myopathy or rhabdomyolysis and have developed kidney or liver problems, you might be eligible to file a lawsuit that would seek damages. To schedule a free review of your case, please contact our Zocor® lawyers today.