The Zocor cholesterol drug, a member of the class of drugs known as statins, is prescribed to many people with high cholesterol when diet and exercise are inadequate. Since 2002, the FDA has issued warnings about Zocor liver damage and increased Zocor myopathy (muscle damage) associated with statins. A recent Zocor SEARCH study shows that higher doses of the Zocor drug (simvastatin) can cause an increased risk of muscle damage and Zocor toxicity. The Zocor study reported muscle damage in nearly one percent of patients taking an 80 milligram dose of Zocor. The FDA has warned that the risk of Zocor side effects is also increased when Zocor simvastatin is combined with certain other drugs.
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The previous Zocor FDA warning in March 2010 is part of an ongoing investigation into Zocor and other cholesterol drug side effects. (An extensive list of Zocor side effects and precautions can be found online.)
Zocor Side Effects
Some additional Zocor warnings include:
- Do not use these medicines if you have liver disease
- Do not use these medicines if you are pregnant or nursing
- Use these medicines with caution if you are also taking Gemfibrozil, Amiodarone, Verapamil, or blood thinners (anticoagulants)
- People who use some HIV medicines, birth control pills (oral contraceptives), Nefazodone, and niacin should talk to their doctor about the specific risks of using statins
- Drinking large amounts of grapefruit juice every day may affect the medicine
If you are starting therapy with simvastatin, or had your dose of Zocor increased, you should contact a health professional immediately if you have experienced symptoms of fever, dark urine, and any unexplained muscle injury, such as muscle cramps, pain, tenderness, stiffness or spasm. You might also consider speaking with an experienced personal injury attorney.
Rhabdomyolysis is treatable and patients can recover if the disease is caught in its early stages. But if the disease is left untreated, acute kidney failure develops in 30-40 percent of patients.
In 2002, the FDA issued its first warning about the risk of rhabdomyolysis to healthcare professionals not to administer more than 20 mg/day of simvastatin to patients receiving heart drugs containing amiodarone such as Cordarone and Pacerone. But in August 2008, the FDA issued another warning because it continued to receive reports of the muscle disease in patients taking both simvastatin and amiodarone. The agency reported that 52 more patients had developed rhabdomyolysis while taking simvastatin and amiodarone between the 2002 original warning and 2008. The FDA first linked Zocor (simvastatin) and another drug, Cardizem (diltiazem, used to treat chest pain or angina), to myopathy in mid-2009 and issued a statement saying it was evaluating the issue to determine if simvastatin labeling, which includes myopathy, is adequate.
Clinical trial data reviewed from SEARCH--the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine—includes new Zocor warnings, prompting the FDA to request that the simvastatin sponsor change the product labeling: healthcare professionals are instructed to avoid prescribing simvastatin doses greater than 40 mg daily when patients are taking the medication diltiazem, due to an increased risk for myopathy.
"Statins kill people—lots of people—and they wound many, many more," Langsjoen writes. He goes on to note that during his time as a doctor he has witnessed "a frightening increase in heart failure secondary to statin usage, 'statin cardiomyopathy'." He further warns about an epidemic caused at least partly by the use of statins.
The concern, according to the petition written by Dr. Julian Whitaker is that Zocor and other statins are linked to a depletion of coenzyme Q10 levels in patients. Depletion of coenzyme Q10 is linked to negative cardiac effects in humans, including congestive heart failure.
Zocor and Liver Disease
Patients who have liver disease are discouraged from using Zocor.
Zocor Side Effects Legal HelpIf you or a loved one have suffered side effects from Zocor, you may qualify for damages or remedies that may be awarded in a possible class action lawsuit. Please click the link below to submit your complaint and we will have a lawyer review your Zocor complaint.
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