The Safety of Metoclopramide in Children: A Systematic Review and Meta-Analysis

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Melissa Lau Moon Lin1, Paula D Robinson2, Jacqueline Flank1,3

  • 1Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.

Drug Safety
|March 23, 2016
PubMed

Insights

Metoclopramide use in children commonly causes reversible side effects like extrapyramidal symptoms, diarrhea, and sedation. Serious adverse events are rare, indicating a generally favorable safety profile for pediatric use.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety and Pharmacovigilance
  • Gastroenterology

Background:

  • Metoclopramide is used for chemotherapy-induced nausea and vomiting (CINV) in adults and children.
  • Recent regulatory updates in Canada and the EU caution against metoclopramide use in young children and limit its duration.
  • Understanding the safety profile of metoclopramide in pediatric populations is crucial.

Purpose of the Study:

  • To review the safety of metoclopramide in children across all indications.
  • To synthesize reported adverse effects from available literature.

Main Methods:

  • Systematic electronic literature search (MEDLINE, Embase) up to March 2015.
  • Inclusion of all English-language studies reporting adverse effects in children (≤18 years).
  • Synthesis of adverse effects with a cumulative incidence of at least 1% from prospective studies.

Main Results:

  • 108 studies involving 2699 pediatric patients were analyzed.
  • Most common adverse effects in prospective studies: extrapyramidal symptoms (EPS) (9%), diarrhea (6%), and sedation (6%).
  • Rarely reported serious adverse events include dysrhythmia, respiratory distress, neuroleptic malignant syndrome, and tardive dyskinesia.

Conclusions:

  • Commonly reported adverse effects (EPS, diarrhea, sedation) in children are typically reversible and not of long-term significance.
  • Life-threatening or slow-to-resolve adverse effects are uncommon with metoclopramide use in pediatric patients.
  • The review supports a generally favorable safety profile for metoclopramide in children when used appropriately.
Abstract

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