High doses of the popular cholesterol-lowering drug Simcor have been linked to an increased risk of serious and potentially life-threatening side effects including severe muscle problems, kidney damage and rhabdomyolysis.
Simcor Lawsuit Overview
Manufactured and marketed by Abbott Laboratories, Simcor is an FDA-approved prescription medication designed to assist in the proper regulation of dangerously high cholesterol levels. Simcor is composed of simvastatin, a statin drug that reduces levels of ‘bad’ cholesterol (low-density, or LDL) and triglycerides in the blood, and Niacin, which is used to increase ‘good‘ cholesterol (high-density lipoprotein, or HDL) and lower triglyceride levels. According to the Centers for Disease Control and Prevention (CDC), statins like Simcor are some of the most commonly prescribed medications for adults 20 and over. However, while studies have shown that statins can lower the risk of having a heart attack or dying from heart disease, high doses of Simcor may also be responsible for a number of severe, life-threatening side effects in certain users.
What’s the problem with Simcor?
In June 2011, the U.S. Food & Drug Administration (FDA) issued a press release stating that the highest approved dose of Simcor – 80 milligrams – had been associated with an elevated risk of the following side effects:
- muscle damage
- kidney damage
- kidney failure
In its announcement, the FDA recommended that no new patients should begin taking the 80mg. dose of Simcor. This is because the risk of side effects is highest during the first 12 months of treatment with the 80mg. dose. Therefore, the administration is recommending that the highest dose only be used in patients who have been taking it for more than one year and have not experienced any problems.
The FDA also implemented updated contraindications and dose limitations for when Simcor is taken with certain other medications. According to the release, “The changes to the label for simvastatin-containing medications are based on the FDA’s review of the results of the seven-year Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine clinical trial, other clinical trial data, and analyses of adverse events submitted to the FDA’s Adverse Event Reporting System.”
Simcor and Rhabdomyolysis
Rhabdomyolysis is a rare but extremely serious medical condition characterized by the breakdown of muscle fibers, which results in the release of an iron and oxygen-binding protein known as myoglobin into the bloodstream. Myoglobin is toxic to the kidneys, thus rhabdomyolysis may often lead to acute kidney damage and even kidney failure. Signs and symptoms of Simcor-induced rhabdomyolysis may include:
- abnormal urine color (dark, red, or cola colored)
- general weakness
- muscle stiffness or aching (myalgia)
- muscle tenderness
- weakness of the affected muscles
Additional symptoms that may be associated with rhabdomyolysis include:
- joint pain
- unintentional weight gain
Fortunately, most cases of rhabdomyolysis are treatable and patients typically recover quickly if caught in its early stages. However, if left untreated, Simcor-induced rhabdomyolysis may lead to acute kidney failure in 30-40% of patients. Proactive hydration, which may involve diuretics and the intravenous administration of fluids, may prevent complications by rapidly eliminating myoglobin from the bloodstream. In the most severe cases, a patient with rhabdomyolysis may have to undergo emergency dialysis.