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FDA Urges Warning Against Extra-Strength Acetaminophen

Four months ago, the U.S. Food and Drug Administration (FDA) issued a warning regarding the use of acetaminophen, a popular over-the-counter medication used to treat a variety of minor ailments, including headaches, muscle aches, fever, and general pain. Although acetaminophen can be found in most Americans' medicine cabinets, it is not without risks. In fact, statistics show that acetaminophen is the leading cause of acute liver failure in the Western world. It is also the second leading cause of liver failure requiring transplants in the U.S.

As a result of mounting concerns regarding acetaminophen and liver damage, the FDA again reiterated its warning on Monday April, 28th for extra strength acetaminophen, which includes medications that contain more than 325 mg of acetaminophen. The warning urges the following:

  • Physicians should stop writing prescriptions for extra-strength acetaminophen.
  • Pharmacists should stop filling prescriptions for extra-strength acetaminophen.
  • Consumers should stop taking medications that contain more than 325 mg of acetaminophen.

Federal officials have stated that the FDA no longer considers extra-strength acetaminophen products safe. Although many products have been voluntarily withdrawn from the market by manufacturers, many over-the-counter products are still available on store shelves.

The FDA issued this warning four months ago, stating that extra-strength acetaminophen showed no improvement in treatment over lower dose products, but did pose increased dangers to the liver. The FDA rarely repeats warnings, but the availability and prevalence of acetaminophen has made it difficult for the FDA to change old habits.


If you have questions regarding acetaminophen liver damage and the rights of injured consumers, The Senators (Ret.) Firmcan help. To discuss your case with a California defective drug lawyer, call 800-773-0849.


Categories: Defective Drugs
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