Zocor is a drug that was created by Merck and first came on the market in 1992. It is now available as a generic under many different names. As a statin, Zocor is a medication used to lower the levels of so-called bad cholesterol in the blood and raise levels of good cholesterol to help prevent heart attacks and strokes in patients vulnerable to them.
Millions of people have taken Zocor since 1992, and many have experienced few side effects and several benefits. However, there are some people who have suffered from the serious and debilitating side effects that, although rare, are certainly possible. Safety warnings have been issued about some of these, like a serious disease called rhabdomyolysis, but they came only after many people were already affected. Lawsuits have been filed against Merck because of Zocor and because of the claim that the company knew about the risks, but failed to communicate them.
What is Zocor?
Zocor is the brand name for the drug created, developed, and sold by Merck that goes by the generic name of simvastatin. The U.S. Food and Drug Administration (FDA) first approved Zocor in 1991 and Merck brought it out to the marketplace in 1992. As a cholesterol-lowering drug, Zocor had wide appeal.
Merck marketed this new drug heavily and used some advertising that was considered misleading. In 1997 the FDA sent a letter to Merck warning that some of their marketing materials for Zocor misled patients and doctors by mispresenting the results of clinical trials. In spite of the misleading marketing, which was in violation of FDA rules, Merck found Zocor to be a big seller.
Uses for Zocor
Zocor is indicated and approved to lower LDL, or bad, cholesterol as well as triglycerides and to raise HDL, or good, cholesterol. It is prescribed in order to reduce the risk of death in patients who have congenital heart defects or who are vulnerable to strokes, heart attacks, and other coronary events. It is also used in patients with certain genetic conditions, such as those that make it impossible to remove cholesterol from the body naturally.
Zocor is supposed to be used as an adjunctive therapy. That means it is not considered to be a single cure for any of the above conditions. It is to be used along with lifestyle changes that promote healthy cholesterol levels, like a healthy diet, exercise, and weight loss.
Along with these lifestyle changes, Zocor is effective at reducing the risk of death in certain patients. The accumulation of bad cholesterol and triglycerides in the arteries slows down the flow of blood and oxygen to the heart, brain, and other parts of the body. This can lead to heart attacks, strokes, and other conditions. By reducing cholesterol, the risk of dying can also be reduced.
Zocor, or simvastatin, belongs to a class of drugs called HMG-CoA reductase inhibitors, more commonly called statins. Statins reduce bad cholesterol and triglycerides in the blood by slowing down the body's production of these substances. They block the action of an enzyme in the liver, which is crucial for making cholesterol. The first statins were approved in 1987, so simvastatin is among the earliest of these drugs.
According to clinical trials and reports of adverse events, the most common side effects of taking simvastatin are upper respiratory infections, abdominal pain, nausea, constipation, and headaches. Some people may experience mild memory loss or confusion. Although rare, a serious allergic reaction is also possible. Signs of this reaction include itchy skin, a rash, hives, swelling in the face and throat, wheezing, and trouble breathing. An allergic reaction should be treated as an emergency medical situation or it can be fatal.
Myopathy and Rhabdomyolysis and Larger Doses
Most of the common side effects of taking Zocor are not serious and many patients tolerate this medication well and receive benefits from it. However, there are some less common but very serious possible side effects that can be devastating and which were not immediately communicated to patients and doctors.
One of these is a condition called myopathy, a type of muscle injury that leads to weakness and muscle pain. The FDA announced this risk in 2011, and stated that the drug can cause myopathy when taken at the 80 milligram dose. The FDA recommended that this dose should only be used in patients who have been taking it already and have not experienced any myopathy.
The risk of myopathy is also increased when simvastatin is taken with certain other medications. Although rare, patients taking Zocor also have an increased risk of developing a very serious type of myopathy called rhabdomyolysis. This condition, if left untreated, can lead to kidney damage and is ultimately fatal. Patients taking Zocor should be aware of the signs of myopathy, which include darkened urine, muscle pain and weakness, fatigue, and decreased urination, and should seek immediate medical attention.
The FDA has made other announcements regarding possible safety risks of statins like Zocor. These are not common, but they are possible and can be very serious. One of these is injury to the liver. Symptoms like fatigue, appetite loss, darkened urine, a yellow coloring of the eyes or skin, and pain or discomfort in the upper right abdominal area could signal liver damage and should be reported immediately. The FDA suggests that all patients be given liver enzyme tests before being given a statin.
The FDA has received a number of reports of mental and cognitive effects of Zocor and other statins. These include memory loss, confusion, forgetfulness, and a fuzzy sort of feeling when it comes to thinking or concentrating. In investigating these reports the FDA found that incidents are not common and the side effects seem to go away after a few weeks of going off the drug.
Statin use has been found to increase the risk of patients developing type 2 diabetes, which is a condition characterized by high levels of sugar in the blood. The risk has been found to be low and the FDA has stated that the benefits of drugs like Zocor outweigh the risks. On the other hand, people who do develop diabetes are at risk for a number of health conditions like vision problems, heart disease, and nerve damage.
Many lawsuits have been filed against Merck because of Zocor. Most accuse the company of not communicating the risks of the medication. Plaintiffs in these cases claim that Merck knew about risks and did not adequately warn patients and their doctors. They also accuse the company of unethical marketing practices, promoting Zocor as more effective and less risky than it really is. The FDA has already accused Merck of this latter charge and so these lawsuits may have some merit.
If you or someone you care about took Zocor and suffered any of the serious side effects, such as myopathy, liver damage, diabetes, or memory loss, you too may have a case against Merck. You could potentially recover monetary damages to help offset the damage that the drug has already done. If you feel like you have a case, and that you deserve compensation for your struggles, consult with a lawyer to help you file or join a lawsuit.
https://www.nlm.nih.gov/medlineplus/druginfo/meds/a692030.html
https://www.merck.com/product/usa/pi_circulars/z/zocor/zocor_pi.pdf
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm293330.htm
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM170610.pdf