FDA Warns More Than 325 mg Per Dose of Acetaminophen May Cause Liver Damage

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Acetaminophen Liver Damage

The U.S. Food and Drug Administration (FDA) started to recommend that healthcare professionals stop prescribing painkillers that contain more than 325 milligrams per dose of acetaminophen because of reports of severe liver damage.

Acetaminophen is often used in pain medications with opioids such as oxycodone (Percocet), hydrocodone (Vicodin) and codeine (Tylenol with Codeine). These are called combination drugs.

The FDA says no data show that taking more than that amount provides enough benefit to outweigh the risk of liver damage.

“Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much,” the FDA said in a statement Tuesday.

“There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider,” said Dr. Sandra Kweder, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, said in 2011. “The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period.”

Mildred Frantz, M.D., who runs a private medical practice in New Jersey, told HealthLine, “Most patients don’t know that prescription medicines like Percocet or Vicodin contain acetaminophen, as do many cough and cold medicines,” she explained. “It’s very easy for a patient to take multiple medications during the day that contain the same ingredient, leading to an overdose. And if a patient combines those medications with even a minimal amount of alcohol, it can lead to irreparable damage to the liver.”

The FDA encourages patients to:

  • Carefully read all labels for prescription and OTC medications and ask if their prescription medicine contains acetaminophen.
  • Don’t take more than one acetaminophen-containing product at one time and that includes OTC medications.
  • Don’t take more than the maximum daily amount of 4 grams, or 4,000 milligrams, of acetaminophen a day.
  • Avoid drinking alcohol while taking acetaminophen.
  • Stop taking acetaminophen and seek medical help immediately if you experience allergic reactions such as rash, itching, swelling of the face and/or difficulty breathing.
  • Seek medical help right away if you think you have taken more than the directed dosage of acetaminophen.

The warning does not apply to over-the-counter drugs such as Tylenol, which contains acetaminophen. The FDA said it will address over-the-counter products in another regulatory action.

FDA pain relievers may cause liver damage

The U.S. Food and Drug Administration (FDA) started to recommend that healthcare professionals stop prescribing painkillers that contain more than 325 milligrams per dose of acetaminophen because of reports of severe liver damage.

FDA warns of acetaminophen liver damage

The Food and Drug Administration is asking doctors to stop prescribing acetaminophen that has more than 325mg per dose.

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