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FDA Consumer Report Acknowledges Additional Statin Risks

Medications of the statin classification have long been considered beneficial in the prevention of heart disease, stroke, heart attack, and similar cholesterol related ailments. The pharmacodynamics of statins exhibit a propensity for the reduction of plaque buildup, therefore reducing the risk of such adverse events. However, recent months have witnessed the statin class of drugs receive an increasing amount of scrutiny. Subsequently, the U.S. Food and Drug Administration (FDA) has released a Consumer Report detailing the expanded risks of statin medications.

According to the FDA Consumer Report, there is important new safety information regarding the cholesterol lowering medications.

Mentioned in the latest FDA report, are several risks that have been acknowledged by the agency. The first of which has found that liver injury associated with statin use is rare but can occur. Amy G. Egan, M.D., M.P.H., deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products (DMEP) explains that statins work in the liver to reduce the production of cholesterol. However, there had been signals in early clinical trials of possible liver damage tied to statin use. Symptoms of liver damage may include unusual fatigue, loss of appetite, right upper abdominal discomfort, dark urine or yellowing of the skin or whites of the eyes.

In addition to the risk of liver damage, the FDA has been investigating reports of cognitive impairment from statin use for several years. After having reviewed a database that detailed bad reactions to statin use, reports indicated memory loss, forgetfulness and confusion in all age groups.

Compounding the list of adverse reactions to statins, is the potential risk for developing diabetes. Diabetes occurs because of defects in the body’s ability to produce or use insulin—a hormone needed to convert food into energy. In the event that the pancreas neglects to create the appropriate amount of insulin or if cells do not react to the insulin correctly, blood sugar levels can spike, and in turn can lead to serious health problems. A small increased risk of raised blood sugar levels and the development of Type 2 diabetes have been reported with the use of statins.

The latest FDA report on statins also indicated a potential risk for a serious muscle injury known as myopathy. The interaction between statins and other drugs may be responsible for this adverse event. Myopathy is characterized by an unexplained weakness or pain in any muscle. Often times myopathy can affect he heart (cardiomyopathy). When this happens, the heart becomes too weak to pump blood throughout the circulatory system. Eventually, the heart becomes too weak and fails to deliver oxygenated blood, resulting in severe, life-threatening complications.

According to Egan, this new information regarding statin risks should not scare patients away. “The value of statins in preventing heart disease has been clearly established,” she says. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

The following is a comprehensive list of statins:

  • Altoprev (lovastatin extended-release)
  • Crestor (rosuvastatin)
  • Lescol (fluvastatin)
  • Lipitor (atorvastatin)
  • Livalo (pitavastatin)
  • Mevacor (lovastatin)
  • Pravachol (pravastatin)
  • Zocor (simvastatin)

Products containing statins in combination with other drugs include:

  • Advicor (lovastatin/niacin extended-release)
  • Simcor (simvastatin/niacin extended-release)
  • Vytorin (simvastatin/ezetimibe)

Do I Have a Statin 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 statin lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured by a statin, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

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