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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Zocor Simvastatin
Zocor, a synthetic statin developed by Merck & Co., was the company's best-selling drug and the second most popular drug worldwide, with sales of $4.3 billion in 2005, the year Merck's patent expired. Simvastatin is an ingredient in Merck & Co's Zocor and Abbott Laboratories Inc's Simcor, and is now sold generically. Zocor was also combined with Zetia as Merck and Schering-Plough Corp's Vytorin— which faced over one hundred Vytorin-Zetia class action lawsuits involving consumer fraud. (Vytorin has been shown to provide no medical benefits over cheaper generic alternatives and its marketing of the medication was investigated by the US Department of Justice.) The Zetia/Vytorin issue has been ongoing with Merck, and a Vytorin-Zetia settlement has been reached.
Zocor Warning
 In June 2011, the US FDA announced a simvastatin warning update, alerting patients to the risk of muscle injury (myopathy) when simvastatin was used at the highest doses (80 mg) and especially within the first 12 months of taking the medication. According to the FDA, no new patients should be put on the 80 mg dose and patients currently on that dose should only continue if they have used simvastatin for more than a year without muscle pain. The warning also applies to Vytorin.
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
More serious Zocor side effects can include myopathy (muscle pain and tenderness), rhabdomyolysis (a breakdown of muscle cells), cardiomyopathy (a decrease in heart muscle function), and liver disease. Zocor or simvastatin side effects can also include gas, dizziness, constipation, headache, diarrhea, or upset stomach.
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
Consult your physician to discuss the full range of Zocor side effects.
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.
Zocor Myopathy
The use of statins is associated with a condition known as statin myopathy, in which the patient experiences muscle pain and tenderness. This condition is reportedly linked to the dose size, meaning the higher the Zocor (simvastatin) dose, the higher the likelihood of experiencing muscle pain. In extreme cases, the muscle cells can break down (a condition known as rhabdomyolysis) and release myoglobin (a protein) into the patient's bloodstream, which can cause damage to the kidneys as the kidneys try to filter the protein out of the bloodstream.
 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.
Zocor Cardiomyopathy
Cardiomyopathy is a life-threatening condition in which the patient's heart muscle does not function properly. Patients who develop cardiomyopathy can experience arrhythmia or sudden cardiac death. According to a 2002 paper by Peter H. Langsjoen, MD (written as the introduction of a petition requesting stronger warnings about statins sent to the FDA), statin side effects can be deadly.
"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
According to information from the Mayo Clinic, statin use can occasionally cause an increase in liver enzymes. In some patients, that increase may be severe and, if not treated, can result in permanent liver damage. Patients are advised to have a blood test six weeks after beginning treatment with a statin, such as Zocor, to ensure their liver is functioning normally. The increase in liver enzymes can often be reversed by discontinuing the medication.
Patients who have liver disease are discouraged from using Zocor.
Zocor Side Effects Legal Help
If 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.
Last updated on Jun-28-11 |
ZOCOR ARTICLES AND INTERVIEWS
FDA Takes Tougher Stand on Zocor 20 Years After Initial Approval
 Washington, DC: The announcement earlier this month by the US Food and Drug Administration (FDA) with regard to serious Zocor side effects has prompted critics to wonder what cumulative damage the 80mg dose of Zocor (simvastatin) has wreaked in the 20 years since its approval by he FDA in 1991 [READ MORE]
Zocor and Simvastatin Hit with New FDA Restrictions
 Washington, DC: Thirteen years after high-dose Zocor was approved by the US Food and Drug Administration (FDA) as a drug whose benefits outweighed its risks, the health regulator has slapped new restrictions on the drug over concern for the onset of myopathy [READ MORE]
FDA Announces Safety Changes for Simvastatin
 Washington, DC: The US Food and Drug Administration (FDA) has announced a change in the safety label for simvastatin (sold under the brand-name Zocor) because high-dose simvastatin has been linked to an increased risk of myopathy. The FDA recommends that 80 mg simvastatin, the highest dose approved by the FDA, only be used in patients who have already taken the dose for 12 months or more and have not developed muscle toxicity. Furthermore, the 80 mg simvastatin dose should not be prescribed to new patients [READ MORE]
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