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FDA Orders New Warning on Statins

Written by Ankin Law Office

Cholesterol-fighting statins, such as Lipitor, Lescol, Pravachol, Crestor, Mevacor, Altoprev, Livalo and Zocor , will soon be required to include additional warnings on the product’s label.  The U.S. Food and Drug Administration (FDA) announced last month that it plans to add language regarding the risk of diabetes to the “warnings and precautions” sections of the labels of statin drugs.

Statins have been used for years by millions of people with clogged arteries and high cholesterol.  Statins work by lowering the levels of LDL, or “bad cholersterol,” thereby reducing the risk of heart attack, stroke, and cardiovascular disease.  Sales of statins in the U.S. in 2010 were approximately $18.8 million, making them the third best-selling class of drugs in the U.S.

The FDA’s decision came as a result of concerns that patients taking cholesterol-fighting statins may face a “small increased risk” of increased blood sugar levels and diabetes.  The FDA also plans to require statin labels to include information about patients experiencing memory loss and confusion.  This side effect was classified as an “adverse reaction,” however, and not placed in the more serious “warnings and precautions” category.

The FDA also announced that it will no longer require statin labels to include a warning related to liver injury.  The drugs previously required routine testing of liver enzymes, but the FDA will now recommend only one test when a patient first begins taking statins.

“We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol,” Dr. Mary Parks of the FDA’s Center for Drug Evaluation and Research said in a written statement.

According to this article, the benefits of statins outweigh their potential harm and patients should continue to consider statins to be a safe and effective treatment option for managing cardiovascular risk.  Patients should report any side effects that they experience to their physician, however.

Drug manufacturers are under an obligation to ensure that the drugs they are providing to patients are safe and effective, including providing the appropriate and necessary warnings on the drugs’ label.  If the drug manufacturer fails to provide a safe and effective product, or fails to include the necessary warning labels on the product, and a consumer is injured as a result, the drug manufacturer may be entitled to compensation in a personal injury or product liability lawsuit. The skilled Chicago unsafe pharmaceutical drug attorneys at Ankin Law Offices, LLC have considerable experience representing clients in a wide variety of personal injury and product liability lawsuits.

Source: “FDA adds diabetes, memory loss warnings to statin labels: Cause for concern?,” CBS News

Categories: Product Liability