For a whole we were monitoring events wondering whether the problems with Zocor would rise justify litigation. We did not rush to that conclusion. We are still not taking Zocor cases. But that could change. Because it now appears clear that these have merit because the evidence that a side effect of Zocor elevates the risk of developing myopathy - particularly when the 80 mg dose of Zocor is prescribed - has reached a critical mass.What is Zocor Used For?
Zocor is a drug that is used to treat patients with hypercholesterolemia who are at high risk of developing atherosclerotic vascular disease. It is made of simvastatin. According to the FDA, about 2.1 million people in the U.S. were prescribed a medication that contained 80-mg simvastatin in year 2010. The 80-mg dose is very effective: LDL cholesterol is decreased by an additional 6% over a 40 mg dose. It important to keep in mind that no one is suggesting that this drug does not help many paitents.
Why not just take Lipitor? Doctors often prescribe Zocor for a reason that is compelling to patients: it is cheaper than Lipitor. But some may have paid a more costly "price" by going with Zocor. (Now, there are diabetes problems - and concerns about cataracts - associated with Lipitor as well.)What is the Connection Between Zocor and Statin-Associated Muscle Injury?
In a letter dated June 8, 2011, Merck announced a change in the prescribing information for Zocor. Changes were made due to concerns about statin-associated muscle injury, specifically the increased risk of myopathy when using the 80 mg dose of simvastatin (Zocor). Merck’s letter had the FDA’s stamp of approval.
What led to the issuance of the letter was the outcome of a clinical study. The SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) clinical trial found that there was a markedly higher risk of patients developing myopathy and rhabdomyolosis when taking a dosage of 80 mg a day of simvastatin. Specifically, the occurrence of myopathy in patients taking 80 mg/day of simvastatin was approximately 0.9% when compared with 0.02% for patients taking 20 mg/day, and the occurrence of rhabdomyolysis in patients taking 80 mg/day was approximately 0.4% versus 0% for patients on 20 mg/day. Myopathy, including rhabdomyolysis, was most likely to occur during the first year of using Zocor.
Myopathy is a muscular disease which causes muscular weakness. A specific type of myopathy is rhabdomyolysis. When a patient has rhabdomyolysis, skeletal muscle rapidly breaks down. If the resulting broken down muscle enters the bloodstream, acute kidney failure may occur. Muscle pain, muscle fatigue that cannot be attributed to other causes, muscle tenderness and elevated muscle enzyme levels in the blood (creatine kinase) are all indicators of myopathy. If there is also fatigue and the patient’s urine is dark or red urine, the patient may have rhabdomyolysis.
Simvastatin is no longer to be prescribed to new patients. The study findings and Merck’s release of new prescribing guidelines were not a great surprise to plaintiffs' lawyers nor to many doctors, however. Many health care providers have, over the past few years, noted the muscle pain experienced by patients taking Zocor. As a result, health care providers began prescribing other statin drugs for their patients so as to avoid the muscle pain associated with simvastatin when taken at high doses.What Did Merck Do Wrong to Warrant Zocor Lawsuits Being Filed?
This is the ultimate question in the Zoloft lawsuits: Did Merck do something wrong - something negligent - to warrant a claim? The evidence is still accumulating. But we think the answer to this question is that Merck did do something wrong. What?
First, there were two large studies were conducted concerning the effects of Zocor prior to its marketing. However, the findings of both studies may be flawed due to the exclusion of a number of test subjects. One study was the “Scandinavian Simvastatin Survival Study” ("the 4S Study") which was published in the Lancet in 1994. The 4S study looked at cholesterol lowering in patients with coronary heart disease.
The second was the 2002 Heart Protection Study that evaluated the safety and efficacy of cholesterol lowering drugs on heart disease. Approximately 20,000 people were involved. Of that total, about 33% ended up being excluded from the study for failing to comply with the study protocols. Those excluded included subjects who experienced problems with the medication and who did not continue its use. An active drug compliance test was used during the study, and some contend that such practices slant study results and thus bring into question the study’s conclusions.
The problem is that some of those individuals excluded may have not complied with study protocols due to the side effects they were experiencing, which could have included myopathy symptoms. In fact, Dr. Beatrice Golomb, a professor at the University of California - San Diego Medical School continues to explore the effects of statins on cognitive and neurological function, primarily because the studies mentioned previously selectively excluded those individuals most susceptible to these side effects.
Zocor is a fat-soluble statin that can easily enter the inside of the muscle cells. Statins reduce the cholesterol the body produces so that the body takes any cholesterol needed from food. According to the Mayo Clinic, statins may affect not only the production of cholesterol by the liver, but also affect enzymes in the cells of muscle that produce muscle growth, which in turn may cause muscle aches.
Prior to marketing and selling Zocor, there should have been further investigation - our lawyers contend - of how statins affected the individuals who were excluded from the statin studies, including what side effects they suffered. This drug should not have been marketed and sold without first exploring this possible problem and without some type of warning about the potential risk of myopathy.What Has Been Done Recently Regarding the Side Effects of Zocor?
Along with the new prescribing guidelines regarding use of the 80 mg dose of Zocor, there is also an augmented list of contraindications with the use of Zocor. Merck’s June 8 letter lists certain drugs that are now contraindicated with the use of Zocor. These drugs include itraconazole, ketoconazole and posaconazole (anti-fungal medications); HIV protease inhibitors; erythromycin, clarithromycin and telithromycin (antibiotics): nefazodone (antidepressant), Gemfibrozil (a cholesterol drug), cyclosporine (an anti-rejection drug used for organ transplant patients), and danazol (a treatment for endometriosis). The use of certain other drugs with Zocor is dosage dependent. With Amiodarone (an an antiarrhythmic medication), Verapamil and Diltiazem (used to treat high blood pressure and angina), Zocor should only be used at a dose of 10 mg per day. Amlodipine (another high blood pressure and angina medication) and Ranolazine (an angina medication) can only be used with a dosage of 20 mg per day or less of Zocor.
The FDA states that patients taking Zocor who are experiencing muscle pain and other symptoms of myopathy should contact their health care providers. 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.How Are Current Lawsuits Based Upon Zocor Side Effects Faring?
Concerns about the dangers of this drug are increasing. Our lawyers will continue to monitor both FDA and Merck statements regarding Zocor and also continue looking at reports of injuries due to the use of Zocor. The alteration of Zocor’s prescribing guidelines is a major indicator that there are some serious problems that are finally being acknowledged by both Merck and the FDA.
There are numerous indicators of many claims on the horizon, including the plethora of information about Zocor on the internet and a growing bank of information showing the detrimental effects of Zocor. Litigation would not likely be a class action lawsuit in the strict legal sense, but the sheer number of cases may require that they all be consolidated so that all of the central fact finding would be handled by one judge.2013 Zocor Update
Earlier this year, Health Canada advised of a new warning with Zocor about the increased blood sugar levels and the risk of diabetes. Why? Health Canada concluded that the risk of diabetes appears to be mainly in patients with pre-existing risk factors for diabetes”.