Rhabdomyolysis Risk in Zocor Prompts FDA To Lower Dosage

Zocor (simvastatin) is a synthetic statin developed by Merck that is designed to lower cholesterol. It is one of Merck's best selling drugs and the second best-selling cholesterol drug in the world. Generic Zocor is widely available and the active ingredient, simvastatin, is also contained in the drugs Vytorin and Simcor with other medications. In June 2011, the FDA issued a warning to doctors about potential side effects of Zocor when used at high doses (80 mg), saying that the cholesterol drug may increase the risk of Zocor muscle injury or myopathy. The warning came after more than a year of FDA experts reviewing clinical trials on Zocor and other drugs containing simvastatin, which had been available to the manufacturers for some time.
In rare cases, the Zocor muscle problems may result in a condition known as rhabdomyolysis. Symptoms of rhabdomyolysis from Zocor could include: muscle cramps, pain, spasms, stiffness and tenderness. Rhabdomyolysis is a serious condition where damaged muscle tissue releases the protein myoglobin into the bloodstream, which may cause kidney damage, kidney failure or death. High doses of Zocor (simvastatin) may increase the risk of this potentially life-threatening condition. The severity of Zocor rhabdomyolysis problems often varies depending on whether kidney function is impacted. Kidney damage from Zocor rhabdomyolysis may lead to decreased urine production or the inability to urinate.
All statins have been found to carry a risk of muscle injury, known as myopathy, and rhabdomyolysis is the most severe form, potentially causing severe kidney damage, kidney failure and death. Due to these risks, the FDA has lowered the prescribed dosage amounts for Zocor to below 80mg. 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. Those suffering from the adverse effects of Zocor are advised to contact an experienced Zocor lawyer to ensure proper representation in filing a Zocor lawsuit.