Zocor Warning Issued by FDA

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Recently, the FDA issued a warning to doctors and patients regarding high doses of Zocor. According to the FDA, high doses of Zocor and other versions of the cholesterol lowering drug simvastatin may cause an increased risk of muscle damage and potentially deadly kidney damage.

After a seven year study, the FDA found the 80 milligram dose of Zocor should only be continued in patients who have been taken that dose for more than a year without injury. They also advised that no new prescriptions should be written at that dosage.

This new warning from the FDA follows their March 2010 statement that they were looking in to the issue of Zocor use. Here is that initial warning.

What is Zocor?

FDA Warns about Increased Risk of Muscle Injury with Zocor

Highest approved dose of cholesterol-lowering medication could cause harm to muscles

The U.S. Food and Drug Administration today warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg. Although muscle injury (called myopathy) is a known side effect with all statins, today’s warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug. Rhabdomyolysis is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and sometimes death.

“Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available,” said Eric Colman, M.D., Deputy Director of FDA’s Division of Metabolism and Endocrinology Products (DMEP). “It’s important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy.”

Simvastatin is sold as a single-ingredient generic medication and as the brand-name Zocor. It also is sold in combination with ezetimibe as Vytorin, and in combination with niacin as Simcor.

FDA’s review of new information on the risk of muscle injury is derived from clinical trials, observational studies, adverse event reports, and prescription use data. The agency also is reviewing data from the SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) trial, which evaluated major cardiovascular events, such as heart attack, revascularization and cardiovascular death, in patients taking 80 mg compared to 20 mg of simvastatin. SEARCH also included data on muscle injury in patients taking simvastatin.

FDA is committed to informing the public about its ongoing safety review of drugs and will update the public as soon as the review of simvastatin is complete.

source: fda.gov

Zocor Side Effects

Most patients tolerate treatment with ZOCOR well; however, like all prescription drugs, ZOCOR can cause side effects, and some of them can be serious. Side effects that do occur are usually mild and short-lived.

Click here for a list of Zocor Side Effects

If you, or someone you care about, has had heart problems related to taking ZOCOR, you should contact our law firm for a free evaluation by:

• Contact our Attorneys so we can evaluate your claim
• Calling toll free 1-855-TELLROBERT. Our phones answer 24 hours a day 7 days a week

Our law firm will evaluate your claim free of charge and advise you on your legal rights to collect compensation. There is no obligation to use our services, and "YOU PAY NO FEE UNLESS THERE IS MONEY FROM YOUR CASE".

Let personal injury attorneys at Robert J. Fenstersheib & Associates represent you in the Zocor Lawsuit.