2. Academic Validation
  3. The Safety of Prochlorperazine in Children: A Systematic Review and Meta-Analysis

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

  • Drug Saf. 2016 Jun;39(6):509-16. doi: 10.1007/s40264-016-0398-9.
Melissa Lau Moon Lin 1,  Paula D Robinson 2,  Jacqueline Flank 1 3,  Lillian Sung 4 5,  L Lee Dupuis 6 7 8
Affiliations

Affiliations

  • 1 Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.
  • 2 Pediatric Oncology Group of Ontario, Toronto, ON, Canada.
  • 3 Department of Pharmacy, The Hospital for Sick Children, Toronto, ON, Canada.
  • 4 Division of Haematology/Oncology, Department of Paediatrics, The Hospital for Sick Children, Toronto, ON, Canada.
  • 5 Research Institute, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.
  • 6 Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada. lee.dupuis@sickkids.ca.
  • 7 Department of Pharmacy, The Hospital for Sick Children, Toronto, ON, Canada. lee.dupuis@sickkids.ca.
  • 8 Research Institute, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada. lee.dupuis@sickkids.ca.
PMID: 26884326 DOI: 10.1007/s40264-016-0398-9
Abstract

Introduction: Prochlorperazine is recommended for adults with breakthrough or refractory chemotherapy-induced nausea and vomiting (CINV). The objective of this review was to describe its safety in children when given for any indication to help define its role for CINV control in children.

Methods: Electronic searches of MEDLINE, EMBASE, PsycINFO, and the Cochrane Central Register of Controlled Trials were performed as of 9 March 2015. All studies in English reporting adverse effects (AEs) associated with prochlorperazine in children (≤18 years) were included. AEs were synthesized for prospective studies.

Results: Forty-nine (15 prospective) studies evaluating the use of prochlorperazine in 758 children were included. The most commonly reported AEs in prospective studies of prochlorperazine in children were sedation (multiple-dose studies: 10 %, 95 % CI 5-21) and extrapyramidal symptoms (EPS) (single-dose studies: 9 %, 95 % CI 3-29; multiple-dose studies: 4 %, 95 % CI 1-11). Serious AEs (seizure, neuroleptic malignant syndrome, autonomic collapse, tardive dyskinesia) were rarely associated with prochlorperazine use in children. Five fatalities were reported in children receiving prochlorperazine.

Limitations: The limitations of this systematic review and meta-analysis were that the AEs reported in the included studies were heterogeneous, the prospective use of systematic clinical tools to identify AEs was rare, and the risk of bias in most prospective studies was moderate.

Conclusions: The most common AEs reported with the pediatric use of prochlorperazine are EPS and sedation. Fatalities, life-threatening, and persistent AEs have also been reported.

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