FDA May Consider Ban of High-Dose Zocor Because of Side Effects

The U.S. Food & Drug Administration (FDA) is currently reviewing data on the side effects of the anti-cholesterol medication Zocor (simvistatin) and will consider “withdrawal of high-dose simvastatin from the market,” according to comments from the FDA scientists published in the latest issue of the New England Journal of Medicine.

On March 19, 2010, FDA issued a “safety communication” to patients and health care professionals concerning its review of safety data for Zocor and other so-called “statins” suggesting that the highest approved dose of Zocor was related to an increased risk of certain types of muscle damage.

Muscle injury, also called myopathy, is a known side effect with all statin medications. Patients with myopathy generally have muscle pain, tenderness or weakness, and an elevation of a muscle enzyme in the blood (creatine kinase). The most serious form of myopathy is called rhabdomyolysis. It occurs when a protein (myoglobin) is released as muscle fibers break down. Myoglobin can damage the kidneys. Patients with rhabdomyolysis may have dark or red urine and fatigue, in addition to their muscle symptoms. Damage to the kidneys from rhabdomyolysis can be so severe that patients may develop kidney failure, which can be fatal.

Since its initial safety alert in 2010, FDA has completed a “comprehensive review” of data from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) clinical trial, other large clinical trials of high-dose statins, and the agency’s Adverse Event Reporting System (AERS). In the recent New England Journal article, FDA summarized the newest study which found that myopathy developed in 52 patients in the 80-mg group (0.9%) but in only 1 patient in the 20-mg group (0.02%). Rhabdomyolysis developed in 22 patients in the 80-mg group (0.4%) but in no patients in the 20-mg group. Statistically, the data indicated that the incidence of myopathy was approximately 3 times as high with the 80-mg dose of simvastatin as with the highest approved doses of two similar drugs, rosuvastatin and atorvastatin. The FDA also conducted analyses of U.S. rhabdomyolysis reports of statin drugs associated and with an outcome of death, from the date of initial marketing approval of each statin through January 1, 2010. This analysis showed that the rates of reported fatal rhabdomyolysis were higher with 80 mg of Zocor than with 80 mg of atorvastatin or with 20 mg and 40 mg of rosuvastatin.

Based on the current available data, “the FDA recommends that the 80-mg dose of simvastatin be used only in patients who have been taking this dose “chronically” (e.g., for 12 months or more) without signs or symptoms of clinically significant muscle toxicity. For these patients, the agency believes that the cardiovascular benefits of high-dose simvastatin outweigh the low absolute risk of myopathy. Patients who require a greater reduction in LDL cholesterol than can be achieved with 40 mg of simvastatin should be given an alternative LDL cholesterol–lowering therapy (e.g., a statin with greater potency that poses a lower risk of myopathy, such as atorvastatin or rosuvastatin).”

The FDA indicated that it will closely monitor prescription-use data over the next year to determine whether the safety-labeling changes and the communication outreach are having their intended effects of limiting new initiation of high-dose Zocor therapy and guiding appropriate use of concomitant medications with Zocor. According to FDA officials, “if evidence indicates that these measures are not effective, the agency will consider additional regulatory action, including withdrawal of high-dose Zocor from the market.”

Do I Have a Zocor Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Zocor lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by Zocor, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.