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New Statin Risks Added to Prescribing Information

Tuesday witnessed the addition of several new and important safety alerts to the prescribing information of cholesterol reducing medications. Otherwise known as statins, these prescription medications are intended to reduce the life-threatening side effects associated with excessive cholesterol and plaque buildup. However, the recent addition of new risks has caused healthcare officials to reevaluate their stance on statins. Though still believed to exhibit a favorable risk/benefit profile, statin use should be exercised with caution due to the risk of liver injury, diabetes, muscle damage, and decreased cognitive ability.

Statins belong to a group of drugs known as HMG-CoA reductase inhibitors. These unique drugs have the inherent ability to reduces the levels of “bad” cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while simultaneously increasing the levels of “good” cholesterol (high-density lipoprotein, or HDL). Each of which are vital in the management of cholesterol levels. Along with diet and exercise, statins can slow down the progression of atherosclerosis, the progressive buildup of plaque in the arteries over time, as part of a treatment plan in adults to lower cholesterol levels. As a result statins may assist in the prevention of stroke, heart attack, and other heart complications.

However, a recent U.S. Food and Drug Administration (FDA) Consumer Update has alerted the public of new risks affiliated with the use of statins. Federal health officials on Tuesday added new safety alerts to the prescribing information for statins, citing rare risks of memory loss, diabetes, muscle pain, and liver injury.

According to the recent report, while rare, severe liver injuries have been associated with the use of statin medications. While statins operate in the liver to reduce the production of cholesterol, a waxy substance that can form plaque on the walls of the arteries, they may have additional adverse effects. While the mechanism of action responsible for these ailments remains ambiguous, healthcare providers believe severe injuries may result from statin use. Signs and symptoms associated with such an injury may include: unusual fatigue, loss of appetite, right upper abdominal discomfort, dark urine or yellowing of the skin or whites of the eyes.

The Consumer Update also marks the first time the FDA has officially linked the use of statins to the development of cognitive complications. According to the notice, the FDA has been investigating reports of cognitive impairment from statin use for several years. Included in the reports were instances of memory loss, forgetfulness and confusion following statin use. In general, cognitive impairment was not serious and was found to be reversible after a shortly discontinuing the drugs.

Further compounding the recent risks associated with statins, are studies that suggest that they may coincide with the development of Type 2 diabetes. Through their distinct mechanism of action, statins may exhibit a propensity for the increase o of blood sugar levels. Therefore, these spiked levels in blood sugar may affect the body’s ability to use insulin. In the event that this happens, serious health problems may occur if diabetes regulation is neglected.

The last risk added to the prescribing information for statins was an increased potential for muscle damage. Some drugs interact with statins in a way that increases the risk of muscle injury called myopathy, characterized by unexplained muscle weakness or pain. Often times, myopathy will affect the heart, resulting in cardiomyopathy. Cardiomyopathy is characterized by a distinct weakening of the heart muscles. The deterioration of heart strength may prohibit the circulation of blood throughout the circulatory system, resulting in severe, life-threatening complications.

This new information should not scare people off statins, says Amy G. Egan, M.D., M.P.H., deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products (DMEP). “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.”

Last year witnessed approximately 21 million Americans receive a statin prescription. Subsequently, the rate in which healthcare providers have been prescribing these medications has been subject to debate. Many feel that statins are over-prescribed. Dr. Sidney M. Wolfe, director of Public Citizen’s health research group, agrees with the notion that statin medications are too often prescribed to those who do not necessarily need them. Accordingly, Wolfe acknowledges that the new FDA Consumer Report should provided more reasons for otherwise healthy people with cholesterol levels less than 240 to not take these drugs.

While the decision on whether or not to take cholesterol lowering medications involves an intricate mix of factors like age, family history and blood pressure, many healthcare officials believe that those with a total cholesterol level around 200 would benefit from the use of statins.

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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