Simvacor Lawsuit

The cholesterol-lowering drug Simvacor (simvastatin) is an international version of Zocor. The drug is used to reduce LDL cholesterol and thereby reduce the risk of heart attack, stroke, and coronary diseases. Unfortunately, the FDA has published multiple warnings about the risk of muscle disease, myopathy, rhabdomyolysis, kidney failure, and death in severe cases. These life-threatening side effects are most likely for people who take high doses of Simvacor (80-mg) or combine Simvacor with other medications, such as amiodarone.

Simvacor Overview

The active ingredient in Simvacor is simvastatin, which is sold under the brand-name Zocor in the United States. Simvacor is an international brand-name for simvastatin, sold primarily in Eastern Europe, Israel, South Africa, and parts of Asia.

Simvacor belongs to a class of drugs called statins, which include some of the most widely-used drugs in existence. Statin therapy has been associated with a reduced risk of cardiovascular events, including heart attack and stroke. The drugs work by inhibiting an enzyme the liver needs to create Low-Density Lipoprotein (LDL) or “bad” cholesterol.

Simvacor and Muscle Injury, Myopathy, Rhabdomyolysis

Simvacor is associated with a risk of a degenerative muscle disease called myopathy. If the condition is not treated, muscle fibers can rapidly break down and release protein into the bloodstream. This protein (called myoglobin) can cause progressive damage to the kidneys, and a severe disease called rhabdomyolysis. In severe cases, rhabdomyolysis can cause kidney failure and even death.

Symptoms of rhabdomyolysis include:

• Muscle pain, cramping, tenderness
• Muscle weakness (especially in the legs or arms)
• Blood has elevated levels of creatine kinase, a muscle enzyme
• Urine is reduced
• Dark-colored urine
• Fatigue
• And more

Simvacor and FDA Warnings

The U.S. Food and Drug Administration (FDA) has published multiple warnings about the risks associated with Simvacor and other drugs containing simvastatin. Many people take statins as a prophylactic against coronary diseases, when in fact they are only supposed to be used after diet, exercise, and lifestyle changes fail to lower cholesterol naturally.

• June 2011 Drug Safety Warning: Due to the increased risk of rhabdomyolysis and muscle injury, the FDA restricts use of high-dose, 80-mg simvastatin to 40-mg doses.
• December 2011 Safety Communication: FDA further restricts simvastatin to 20-mg doses when it is combined with amiodarone (a drug used to treat life-threatening irregular heart rhythm)

Simvacor and Type-2 Diabetes

Researchers have associated the use of Simvacor and other statins with an increased risk of type-2 diabetes, a chronic metabolic disorder. The study, published in the Journal of the American Medical Association, aggregated data from 13 placebo-controlled studies and found statins were associated with a 9% increased risk of type-2 diabetes over a 4-year period, compared to a placebo. The results from the study highlight the importance of using statins only have diet, exercise, and lifestyle changes have failed to reduce cholesterol levels.