FDA: Clinicians Should Not Prescribe High-Dose Acetaminophen Products — Physician’s First Watch

Medical News |
January 16, 2014

FDA: Clinicians Should Not Prescribe High-Dose Acetaminophen Products

By Kristin J. Kelley

Healthcare professionals should not prescribe combination drugs that contain more than 325 mg of acetaminophen per tablet or capsule, the FDA advised on Tuesday in an effort to reduce patient risk for liver injury from accidental overdose.

Nearly half of acetaminophen-related liver failure cases in the U.S. are caused by accidental overdose from prescription combination drugs, the agency said. In particular, severe liver injury has occurred in three common scenarios, when patients:

  • took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period;

  • took more than one acetaminophen-containing product at the same time;

  • drank alcohol while taking acetaminophen products.

Moreover, according to FDA data, the benefits of taking more than the recommended dose do not outweigh the added risks.

In 2011, the FDA asked manufacturers to limit acetaminophen doses to no more than 325 mg per pill by January 14, 2014, but some products are still on the market.

Reader Comments (11)

jafar Physician, Emergency Medicine, iran

It's very good, poisoning with acetaminophen will be reduced.

MBBS, PhD Physician, Family Medicine/General Practice

In rural as well as metropolitan India, practicing doctors are often guided by the "tradition of medical culture". This culture has taught us about previous, often high, dosages of paracetamol. It may be difficult to overcome this trend. Moreover, there must remain specific alternatives to paracetamol to control pain and fever. If these are not clearly stated, I'm afraid, new guideline may not be properly followed.

Emmanuel Tigalya

FDA should also provide guidance on alternative agents where patients rely on acetaminophen to manage pain on a daily basis.

alfredo casaliba Physician, Nephrology, hospital

Already known but very good


That's very important & useful info to reduse liver transplant

Gustavo Adrián Isacaz Physician, Internal Medicine

In the case of acetaminophen, less is better.

Ronald K Rogers MD Physician, Psychiatry, Retired

I agree 100%


does this apply only to combinations or to plain acetaminophen as well?

Junior Destine MD Medical Student, Family Medicine/General Practice, Clinical & Herbal Innovation Inc

I am really happy about the fact that this is being prevented now!..

Benjamin B Okel, MD

That's very important info that has not been sufficiently emphasized.
Thank you.

Marc Tanenbaum, MD Physician, Pediatrics/Adolescent Medicine

I have long thought that the FDA should prohibit acetaminophen from being included in pediatric liquid combination products for cough and cold medications for the same reason.

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