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

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

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

Drug Safety
|February 18, 2016
PubMed

Insights

Prochlorperazine use in children can cause sedation and extrapyramidal symptoms (EPS). While rare, serious adverse events including fatalities have been reported, necessitating careful consideration for pediatric use.

Area of Science:

  • Pediatric Pharmacology
  • Adverse Drug Reactions
  • Systematic Review and Meta-Analysis

Background:

  • Prochlorperazine is a recommended treatment for chemotherapy-induced nausea and vomiting (CINV) in adults.
  • Its safety profile in children for various indications requires comprehensive evaluation to inform CINV management.

Purpose of the Study:

  • To systematically review and synthesize the safety data of prochlorperazine in pediatric populations.
  • To define the role of prochlorperazine for CINV control in children based on its adverse event profile.

Main Methods:

  • Conducted comprehensive electronic literature searches across multiple databases (MEDLINE, EMBASE, PsycINFO, Cochrane).
  • Included all English-language studies reporting adverse effects (AEs) of prochlorperazine in children (≤18 years).
  • Synthesized AEs from prospective studies.

Main Results:

  • Analyzed 49 studies involving 758 children.
  • Common AEs included sedation (10% in multiple-dose studies) and extrapyramidal symptoms (EPS) (9% single-dose, 4% multiple-dose).
  • Serious AEs and five fatalities were reported, though rarely associated with prochlorperazine.

Conclusions:

  • The most frequent adverse events associated with pediatric prochlorperazine use are EPS and sedation.
  • Fatalities and other severe, persistent adverse events have been documented, highlighting the need for cautious administration.
Abstract

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