Simvacor (simvastatin) is a international brand-name of simvastatin (sold as Zocor in the United States), a medication that is used to lower cholesterol levels and reduce a person’s risk of heart attack, stroke, and other coronary events. Unfortunately, Simvacor and other statins have been associated with an increased risk of muscle disease, myopathy, rhabdomyolysis, or kidney failure in severe cases. This risk is greatest for people taking high-dose Simvacor (80-mg) or combining Simvacor with amiodarone and certain other medications.
What is Simvacor?
Simvacor (simvastatin) is a medication that belongs to the statin class of drugs, which lower levels of Low-Density Lipoprotein (LDL) cholesterol (or, “bad” cholesterol) by blocking an enzyme in the liver. Studies have shown statin therapy significantly reduces cardiovascular events, and higher doses of statins further reduce this risk.
Simvacor and Muscle Injury
One of the most serious risks associated with Simvacor and other statins is muscle injury. In mild cases, this condition is called myopathy, and it is characterized by the breakdown of muscle fibers. If the disease is not treated promptly, it can progress to rhabdomyolysis, which can be life-threatening. Rhabdomyolysis occurs when deteriorating muscle fibers release protein into the bloodstream, which can severely damage the kidneys.
Symptoms of rhabdomyolysis include:
- Muscle pain, tenderness, cramping, or swelling
- Weakness, especially in the arms or legs
- Elevated levels of the muscle enzyme creatine kinase
- Dark or cola-colored urine
- And more
Simvacor and FDA Warnings
Simvacor and other statins are among the most popular, widely-used medications in existence. Although they are only supposed to be used as a last resort after diet, exercise, and lifestyle changes have failed to lower cholesterol, many people take statins as a prophylactic for cardiovascular disease.
The FDA has attempted to raise awareness about the risks of long-term, high-dose statin use by publishing several safety communications. In June 2011, the FDA issued a Drug Safety Warning to announce that they would restrict the use of high-dose, 80-mg Simvacor to 40-mg because of the risk of muscle injury.
A few months later, in December 2011, the FDA published another Safety Communication to advise limiting simvastatin to 20-mg per day when combined with amiodarone, a popular medication used to control irregular heart rhythm.
Simvacor and Diabetes
In June 2011, a study published in the Journal of the American Medical Association associated the use of statins with an excess risk of developing type-2 diabetes. The researchers conducted a meta-analysis of 13 randomized placebo-controlled studies, and found a 9% increased risk of diabetes over a 4-year period compared to patients treated with a placebo or no drug.