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Safety of ibuprofen in infants younger than six months: A retrospective cohort study

Paul Walsh1, Stephen J Rothenberg2, Heejung Bang3

  • 1Pediatric Emergency Medicine, Sutter Medical Center Sacramento, Sacramento, CA, United States of America.

Plos One
|June 29, 2018
PubMed

Insights

Ibuprofen did not cause more gastrointestinal (GI) and renal adverse events (AE) when prescribed before six months of age. However, infants under six months prescribed ibuprofen experienced more GI AEs than those prescribed acetaminophen alone.

Area of Science:

  • Pediatric pharmacology
  • Drug safety in infants
  • Gastrointestinal and renal adverse events

Background:

  • Infants under six months are a vulnerable population for adverse drug events.
  • Understanding the comparative safety of ibuprofen and acetaminophen in young infants is crucial for clinical practice.

Purpose of the Study:

  • To investigate if early ibuprofen exposure (before six months) increases gastrointestinal (GI) and renal adverse events (AE) in infants.
  • To compare the incidence of GI and renal AEs between ibuprofen and acetaminophen use in infants younger than six months.

Main Methods:

  • Retrospective cohort study using California Medicaid data (2004-2010).
  • Two cohorts were analyzed: ibuprofen timing and ibuprofen vs. acetaminophen in infants <6 months.
  • Incidence rate ratios (RR) for GI and renal AEs were calculated.

Main Results:

  • No increased risk of GI or renal AEs was found when ibuprofen was first prescribed before six months of age.
  • Infants younger than six months prescribed ibuprofen showed a higher incidence of any GI AE (aRR 1.25) and moderate/severe GI AE (aRR 1.24) compared to acetaminophen alone.
  • No significant differences in severe GI or renal AEs were observed between ibuprofen and acetaminophen groups.

Conclusions:

  • Prescribing ibuprofen before six months of age was not associated with higher GI or renal adverse events compared to later prescription.
  • Ibuprofen use in infants under six months was linked to an increased risk of gastrointestinal adverse events when compared to acetaminophen monotherapy.
Abstract

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