Managing and maintaining a healthy cholesterol level begins with a healthy lifestyle. However, Simcor (niacin and simvastatin) is a prescription cholesterol medication intended to help people who are, otherwise, unable to do so on their own. Unfortunately, the prolonged use of Simcor may coincide with severe, life-threatening side effects. Patients who undergo a strict regimen of Simcor may increase their risk of developing kidney failure, muscle damage, myopathy and in the most severe circumstances, rhabdomyolysis.
If you or a loved one has been injured by Simcor, you should contact our lawyersimmediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Simcor Lawsuit Overview
Simcor, a product of Abbott Laboratories, gained the approval of the U.S. Food and Drug Administration (FDA) on February 15, 2008. It is a relatively new prescription drug that belongs to a unique group of medications that assist in the proper regulation of dangerously high cholesterol levels. Other popular prescription cholesterol medications include Zocor and Vytorin, each of which utilize a unique active ingredient known as simvastatin.
Simcor is comprised of two main active ingredients. The first of which, is known as simvastatin. Simvastatin resides in a group of medications known as HMG CoA reductase inhibitors (statins). As a statin, simvastatin reduces levels of “bad” cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of “good” cholesterol (high-density lipoprotein, or HDL). The second active ingredient found in Simcor is niacin. An ingredient that is widely used to increase HDL and lower triglyceride levels. Niacin, in association with simvastatin, may help regulate cholesterol levels in patients.
Unfortunately, the use of prescription cholesterol medications like Simcor may not demonstrate a favorable risk-benefit profile. Recent studies suggest that simvastatin may be responsible for severe, life-threatening complications. Patients who use Simcor may increase their risk of developing catastrophic side effects such as kidney failure, muscle damage, myopathy and rhabdomyolysis. Due to the severity of rhabdomyolysis, patients may contact a Simcor lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Simcor lawsuit.
Simcor Side Effects
The side effects listed below have been linked to the use of Simcor:
- Rhabdomyolysis
- Muscle damage, pain, tenderness, or weakness
- Myopathy
- Kidney failure
- Dark red urine
- Lack of energy
- Fever
- Flushing
- Blisters
- Rash
- Difficulty breathing
- Joint pain
Due to the severity of these side effects, patients may contact a Simcor lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Simcor lawsuit.
Simcor Rhabdomyolysis
Simcor complications have recently been linked to musclular injuries that may result in a serious problem known as rhabdomyolysis. Simcor rhabdomyolysis is characterized by the breakdown of muscle fibers that releases myoglobin into the bloodstream. Accordingly, dead muscle fibers can cause excessive amounts of fluid to transfer from the blood into the muscles. If such an event happens, the fluid volume of the body may be significantly lowered, leading to shock and low blood flow to the kidneys. An event such as this can prove to be hazardous to a kidney.
Renal failure, or kidney failure as it is known, occurs when the kidney is unable to remove excess and harmful myoglobin compounds. As a result, the kidney fails to operate properly and poses a potentially fatal threat to the patient. Due to the severity of rhabdomyolysis, patients may contact a Simcor lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Simcor lawsuit.
FDA Simcor Warning
In June 2011, the FDA issued a Safety Alert regarding the use of statins like Simcor. Any patient on a strict Simcor regimen needs to be advised of an increased risk of myopathy, a complication that could potentially lead to rhabdomyolysis. The risk of myopathy and rhabdomyolysis is significantly increased in the presence of increased statin activity in the blood. Simvastatin is metabolized by the cytochrome P450 isoform 3A4. Certain drugs which inhibit this metabolic pathway can raise the plasma levels of simvastatin and may increase the risk of myopathy.
The following clinical trial illustrates the dangers associated with taking Simcor:
In a clinical trial in which 12,064 patients with a history of myocardial infarction were treated with simvastatin (mean follow-up 6.7 years), the incidence of myopathy (defined as unexplained muscle weakness or pain with a serum creatine kinase [CK] >10 times upper limit of normal [ULN]) in patients on 80 mg/day was approximately 0.9% compared with 0.02% for patients on 20 mg/day. The incidence of rhabdomyolysis(defined as myopathy with a CK >40 times ULN) 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.
Do I Have a Simcor Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Simcor lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Simcor, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.