What FDA recommendations are aimed at reducing the incidence of acetaminophen–induced hepatotoxicity?

Updated: Jan 17, 2020
  • Author: Susan E Farrell, MD; Chief Editor: Michael A Miller, MD  more...
  • Print

In June 2009, the FDA announced requirements for nonprescription and prescription medications to provide new information regarding acetaminophen–induced hepatotoxicity. [15, 16, 17] The FDA addressed the possibility of removing acetaminophen from some popular analgesic combination products (eg, hydrocodone-acetaminophen [Vicodin]) and/or lowering the maximum cited daily dose of acetaminophen. The following concerns were also addressed:

  • Safe daily dose for healthy individuals (all ages: children and adults)
  • Safe daily dose for patients with chronic liver disease
  • Safe daily dose for patients who concurrently drink alcohol
  • Appropriate dose needed for efficacy
  • Package size restrictions
  • Current formulations of acetaminophen-narcotic combination drugs

In January 2011, the FDA asked manufacturers of prescription acetaminophen combination products to limit the maximum amount of APAP in these products to 325 mg per tablet, capsule, or other dosage unit. [6] And in January 2014, the FDA issued a statement advising doctors to stop prescribing combination prescription pain relievers that contain more than 325 mg of acetaminophen per tablet, capsule, or other dosage unit. [7, 8]

In addition, in May 2011 an industry-wide transition to one standard concentration of 160 mg/5 mL for all single-ingredient OTC pediatric liquid acetaminophen products was announced. [18] Previously, mainly two concentrations of OTC APAP formulations were available: 80 mg/0.8 mL (Infant Concentrated Drops) and 160 mg/5 mL (Children's Liquid Suspension or Syrup). The move to a single standard concentration was intended to minimize confusion of administration of acetaminophen preparations by caregivers. However, some household may still have bottles of the older 80 mg/0.8 mL concentration.

The hope is that establishing these formulation changes will help reduce the occurrence of acetaminophen overdosing for both children and adults and decrease the number of acute ingestions that cause hepatotoxicity, leading to acute liver failure. [6]

Did this answer your question?
Additional feedback? (Optional)
Thank you for your feedback!