Consumer Watch Group Calls For Ban of Zocor

Zocor (simvastatin) is a synthetic statin developed by Merck that is designed to lower cholesterol. Zocor is part of a class of drugs called statins that are used to treat high LDL (bad) cholesterol. Simvastatin is also sold in generic versions, and is an active ingredient in the combination drugs Vytorin and Simcor. Muscle injury has long been recognized as one of the possible Zocor side effects, and the labels of these medications all bear warnings regarding this risk. In 2010, the U.S. Food and Drug Administration (FDA) updated the labels of high-dose simvastatin to warn of an association with muscle injuries.

The FDA now says that doctors should no longer prescribe 80 milligrams of Zocor unless a patient has already been taking the dose for a year without any apparent trouble. But not everyone agrees that the warning goes far enough. Public Citizen has placed the Zocor 80 mg doses on its “Do Not Use” list, following an FDA warning about the risk of serious and potentially life-threatening muscle injury from Zocor that was issued earlier this week. The FDA announced June 8 that it is recommending that no new patients be started on an 80 mg Zocor (simvastatin) regimen, due to the risk of high dose Zocor side effects including

Zocor Dose Matters in Patients With Side Effects

Cholesterol-lowering drugs like Zocor have been beneficial to many patients since they hit markets, lowering the risk of heart disease and stroke associated with high cholesterol levels in their bloodstream and other complications that can manifest if a patient’s cholesterol is too high. However, there may be serious Zocor side effects that can make taking the drug more risky than beneficial.

The Food and Drug Administration released a warning in early June warning against use of the highest dose (80 mg) of Zocor, as this dose has been the one most obviously associated with serious side effects including muscle damage, myopathy, and rhabdomyolysis. Muscle weakness and muscle pain have also been linked to Zocor use and can have a serious impact on a patient’s health and wellbeing.

Patients who file a Zocor lawsuit, as many have been doing, may be more successful at gaining some kind of settlement if they were taking the 80mg dose of Zocor as opposed to lower doses such as the 20mg dose. This is not to say that patients on lower doses who experienced Zocor side effects will not be eligible to file a lawsuit, but their cases may be more difficult to argue and prove, and Zocor lawyers will be more likely to be able to help plaintiffs who were taking the recently-banned high doses of Zocor because of the recent FDA warning against the prescription of this dose.

How Zocor Works and Why It Can Be Dangerous

Zocor, a synthetic statin developed by Merck, is designed to lower cholesterol. It is one of Merck's best selling drugs and the second best-selling cholesterol drug in the world. Generic Zocor is widely available and the active ingredient, simvastatin, is also contained in the drugs Vytorin and Simcor with other medications. LDL ( low-density lipoproteins ) cholesterol is responsible for a number of health problems, including high blood pressure, atherosclerosis, stroke and heart attack. This is particularly relevant to atherosclerosis. It is caused by the accumulation of cholesterol in the arteries which leads to arterial hardening and blockages. Statins are also used in cases where there is a history or risk of cardiovascular diseases, even if cholesterol levels are normal. So, why then are the number of Zocor lawsuits and other statin-based drugs on the rise?  If you've been paying attention to a Zocor lawyer, the answer is alarming.

The FDA recently issued a warning that 80mg Zocor doses increase the risk of rhabdomyolysis and other forms of myopathy. The warning applied to all drugs that contain simvastatin, the active ingredient in Zocor.

Zocor May Break Down Muscles Which Can Cause Kidney Failure

The FDA recently issued a warning that 80mg Zocor doses increase the risk of rhabdomyolysis and other muscle injuries, which can lead to renal failure. The warning applied to all drugs that contain simvastatin, the active ingredient in Zocor. In addition to generic Zocor equivalents, simvastatin is included in the combination cholesterol drugs Vytorin and Simcor. Patients taking the highest dosage of Zocor - 80 mg - during their first year of treatment face the greatest risk of muscle injury. At its most severe, Zocor muscle injury can lead to rhabdomyolysis, a disorder that can damage the kidneys and lead to kidney failure and possibly death. Approximately 5 out of 100,000 individuals suffering from Zocor rhabdomyolysis side effects who were prescribed the 80mg dose had to be hospitalized. Zocor lawyers are preparing to file lawsuits on behalf of clients injured by Zocor. 

                       

On June 8, 2011, the FDA added new warnings to the labels of Zocor and other simvastatin (cholesterol-lowering) drugs and recommended that patients not be prescribed the 80 mg dose during the first 12 months of treatment in order to mitigate the Zocor muscle injury risk. The new restrictions and warnings also apply to Vytorin and Simcor. In addition, the labels for simvastatin, Vytorin and Simcor were changed to include new dosing recommendations when these drugs are used with certain medications, such as blood pressure medicines amlodipine and diltiazem, which interact to increase the level of simvastatin in the body, which can increase the risk for myopathy. 

Rhabdomyolysis is a rare muscle condition in which the skeletal muscle is damaged and releases myoglobin into the bloodstream. When it is filtered out by the kidneys, it could cause severe kidney failure or death. During this process, the dead muscle fibers release a toxic substance known as myoglobin into the bloodstream that may harm the kidney and ultimately lead to acute kidney failure. Acute kidney failure is the sudden loss of the ability of the kidneys to remove waste and concentrate urine. Statins are among the best-selling drugs in the United States, with $14.5 billion in combined sales in 2008. It’s nearly impossible to know how many people have been exposed to these Zocor side effects.