Our lawyers are reviewing potential Zocor class action lawsuits. Actually, the Zocor lawsuits would not be a class action in a legal sense of the definition. But the cases might get consolidated for discovery which means all of the central fact finding would be in one venue under one judge.
We started providing comprehensive information on potential Zocor lawsuits last year. This month, the FDA upped the ante, providing fresh fodder for Zocor lawsuits. In a June 8, 2011 letter, the FDA said:
Important Drug Warning. The FDA has reviewed this letter and agrees with its contents.
Merck announced that the prescribing information for Zocor had been changed due to concerns about statin-associated muscle injury, specifically the increased risk of myopathy when using the 80 mg dose of simvastatin (Zocor).
Clearly, for plaintiffs’ lawyers and many doctors, this is old news. Many physicians have already switched patients to other statin drugs, having already noted the muscle pain problems patients were experiencing over the past few years.
What exactly is Zocor? Zocor is made of simvastatin and is also sold in generic form. Zocor is prescribed to treat patients with significantly increased risks of atherosclerotic vascular disease due to hypercholesterolemia. The FDA reports that the 80-mg dose lowers the LDL cholesterol by an additional 6% over simvastatin 40 mg, and that an estimated 2.1 million patients in the U.S. were prescribed a product containing 80-mg simvastatin in year 2010.
Some may wonder why the new Zocor prescribing information is such a big deal. The changes were brought about by the SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) clinical trial, which found that myopathy in patients on simvastatin 80 mg/day was approximately 0.9% compared with 0.02% for patients on 20 mg/day. The incidence of rhabdomyolysis in patients on 80 mg/day was approximately 0.4% compared with 0% for patients on 20 mg/day. The incidence of myopathy, including rhabdomyolysis, was highest during the first year and then notably decreased during the subsequent years of treatment.
Myopathy is a disease that causes muscular weakness. Rhabdomyolysis is a very specific type of myopathy, in which there is a rapid break down of skeletal muscle due to muscle tissue injury. The broken down material can be released into the bloodstream and may cause acute kidney failure. Signs and symptoms for myopathy include unexplained muscle fatigue, muscle pain, tenderness and an elevation of a muscle enzyme in the blood (creatine kinase). Rhabdomyolysis is often characterized by fatigue and dark or red urine, in addition to the symptoms of myopathy.
Study findings specifically mention that there is an increased risk of myopathy, including rhabdomyolysis, when simvastatin 80 mg is compared with other statin therapies that have similar or greater LDL-C–lowering efficacy and with lower doses of simvastatin. Simvastatin is no longer to be prescribed to new patients.
Beyond just the concern about the 80 mg dose, Zocor now has an updated and expanded list of contraindications, which are listed in both the letter and at the Simvastatin website (http://www.simvastatininfocenter.com/). Some drugs are strictly contraindicated with the use of Zocor. The use of other drugs with Zocor is dosage dependent. On the website, Merck urges patients taking Zocor to: “Tell your doctor right away if you experience unexplained muscle pain, tenderness, or weakness.”
Patients are further urged to consult with their doctor if they believe they are affected by the prescribing changes, and should not stop taking the drug until they have conferred with their doctor.
It seems that awareness of the potential dangers of Zocor is ratcheting up. We’ll continue to track the increased Zocor injury risks. The fact that prescribing guidelines have been altered is significant, but there is still a chance of a Zocor recall or withdrawal.
If you think you have a potential Zocor lawsuit, call 800-553-8082 or get a free on-line consultation here.