Simvastatin, a widely-prescribed cholesterol-lowering ingredient found in many popular FDA-approved ‘statin’ medications, has recently been linked to severe muscle damage, myopathy, rhabdomyolysis, and kidney failure. In response to numerous reports of these types of side effects in simvastatin users, the FDA has recommended limiting the highest approved dose of the drug to 40 mg. per day in most patients. The simvastatin lawyers at Schmidt & Clark, LLP, are currently offering free, no-obligation consultations to individuals injured by simvastatin side effects.
Simvastatin belongs to a class of drugs known as ‘HMG CoA reductase inhibitors’ which are designed to reduce levels of ‘bad’ cholesterol (low-density lipoprotein, or ‘LDL’) and triglycerides in the blood, while simultaneously increasing levels of ‘good’ cholesterol (high-density lipoprotein, or ‘HDL’). In addition to being prescribed to patients with cholesterol problems, simvastatin is also commonly used to reduce the risk of stroke and heart attack in individuals with diabetes, coronary artery disease (CAD), and other serious health conditions. Medications whose active ingredients contain simvastatin include:
Side Effects of Simvastatin
Despite being found in a wide variety of best-selling cholesterol medications, simvastatin has recently been linked to a number of serious, potentially life-threatening side effects including:
- muscle damage
- kidney damage
- kidney failure
Simvastatin FDA Warning
In June 2011, the U.S. Food & Drug Administration (FDA) issued a press release announcing that two simvastatin-containing drugs, Zocor and Vytorin, would have their warning labels updated to include information about the increased risk of myopathy (muscle damage), and its more severe form, rhabdomyolysis, associated with the highest dose of the drug. According to the FDA, patients at greatest risk for developing these conditions are those who take the 80 mg. dose daily during their first year of treatment. Additionally, myopathy and rhabdomyolysis may also be linked to patients who take simvastatin in combination with other medications, and that in some individuals, a genetic predisposition may exist.
Simvastatin & Rhabdomyolysis
Rhabdomyolysis is a severe form of muscle damage characterized by the rapid breakdown of skeletal muscle. As the muscle cells deteriorate, cellular byproducts and a protein called myoglobin are released into the bloodstream. When this occurs, the kidneys may be damaged as they attempt to filter the excessive amount of myoglobin out the patient’s system, leaving that person at risk for developing kidney injuries such as tubular necrosis, kidney failure, and even death. Signs and symptoms of simvastatin-induced rhabdomyolysis may include (but are not limited to):
- Dark, red, or cola-colored urine
- Overall or general weakness
- Myalgia (muscle pain)
- Muscle tenderness
- Weakness of the effected muscles