Abbott Laboratories‘ popular cholesterol lowering drug Simcor has been linked to an increased risk for a number of serious and potentially fatal muscle conditions. In June 2011, the U.S. Food & Drug Administration (FDA) issued a press release warning the public about the side effects of Simcor, stating that the medication had been linked to rhabdomyolysis, myopathy and kidney damage. As a result of the abnormally high health risks associated with Simcor, users may be entitled to compensation for their injuries by filing a Simcor lawsuit.
Simcor Update 3/1/12: The U.S. Food & Drug Administration (FDA) issued a press release today informing healthcare professionals of updates to the prescribing information concerning adverse interactions between protease inhibitors and certain statin medications. When these two types of drugs are taken together, they may raise the blood levels of statins and increase the risk of a severe muscle injury known as myopathy.
Simcor Update 2/28/12: The U.S. Food & Drug Administration (FDA) issued a press release today stating that it will be requiring all statin drugs to carry a new warning about the increased risk of elevated blood sugar and possible transient memory and cognition problems. The label changes will apply to atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), lovastatin extended-release (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor).
What’s the problem?
Manufactured and marketed by Abbott Laboratories, Simcor (niacin and simvastatin) is an FDA-approved medication used to lower cholesterol and triglycerides (types of fat) in the blood. Simcor is intended to be used along with a balanced diet to lower levels of total cholesterol and ‘bad’ cholesterol (low-density lipoprotein, LDL), and to increase levels of ‘good’ cholesterol (high-density lipoprotein, HDL) in the body.
Niacin is a B vitamin that occurs naturally in plants and animals, and is also found in a variety of multiple vitamins and nutritional supplements. Simvastatin is a statin drug that reduces levels of LDL and triglycerides in the blood, while increasing levels of HDL. In addition to Simcor, other medications in the statin class include Zocor, Vytorin, Crestor, Lipitor, Lescol, Mevacor, Altoprev, Livalo, Pravachol, Advicor, and Simlup.
Simcor Side Effects
High doses of Simcor have recently been linked to the following potentially life-threatening side effects:
- muscle damage
- kidney damage
- kidney failure (also known as renal failure)
Rhabdomyolysis is a rare but serious condition where damaged muscle tissue releases the protein myoglobin into the bloodstream, which may cause severe kidney injuries and even death. Compensation may be available for individuals diagnosed with Simcor-induced rhabdomyolysis, whose symptoms may include:
- muscle pain
- tenderness, weakness or swelling of the affected muscles
- low blood pressure
- abnormal heart rate and rhythm
According to information recently published by the FDA, nearly five out of every 100,000 patients treated with an 80-mg dose of Simcor or other medication containing simvastatin may be hospitalized with rhabdomyolysis, most often within the first year of treatment. As a result of manufacturers’ negligence in failing to warn the public and medical communities about this risk, millions of people have been prescribed a drug containing 80mg. doses of simvastatin. If you or someone you know has been diagnosed with rhabdomyolysis after taking high doses of Simcor, you may be entitled to compensation by filing a lawsuit.
Simcor Kidney Failure
The term ‘kidney failure’ refers to the sudden loss of the ability of the kidneys to remove waste and concentrate urine without losing electrolytes. Kidney failure can occur from an acute situation, chronic problems or from high doses of statin medications like Simcor. Signs and symptoms of Simcor-induced kidney failure may include (but are not limited to):
- weight loss
- nocturnal urination
- more or less frequent urination habits
- bone damage
- muscle cramps
- abnormal heart rhythms
- muscle paralysis
- swelling of the legs, ankles, feet or hands
- low blood pressure
FDA Warning on Simcor
In June 2011, the FDA issued a press release recommending new safety criteria for high doses of simvastatin, a key ingredient in Simcor:
“The FDA has revised the drug labels for simvastatin and Vytorin to include the new 80 mg dosing restrictions. The agency also revised the labels for simvastatin, Vytorin and Simcor to include new dosing recommendations when these drugs are used with certain medications that interact to increase the level of simvastatin in the body, which can increase the risk for myopathy. Patients who are unable to adequately lower their level of LDL-C on simvastatin 40 mg should not be given the higher 80 mg dose of simvastatin; instead, they should be placed on an alternative LDL-C-lowering treatment(s).”
The administration’s recommendation was prompted by a comprehensive review of data from the Adverse Event Reporting System (AERS), one of the FDA’s most important tools for tracking the safety of drugs once they are on the market. Although the FDA has decided not to issue a recall for simvastatin-containing medications, the agency has stated that it is continuing to monitor data to determine if the labeling changes are successful in limiting the use of 80mg. simvastatin. Doctors should not prescribe Simcor in new patients, including patients already taking lower doses of the drug. Only individuals who have been taking the 80mg. dose for more than a year should continue using it, because the risk of side effects is greatest during the first 12 months.