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

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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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Acknowledgments

The assistance of Ms. Elizabeth Uleryk, Library Scientist, with the literature search and the administrative assistance of Ms. Sandra Cabral are gratefully acknowledged.

Author information

Authors and Affiliations

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

    Melissa Lau Moon Lin, Jacqueline Flank & L. Lee Dupuis

  2. Pediatric Oncology Group of Ontario, Toronto, ON, Canada

    Paula D. Robinson

  3. Department of Pharmacy, The Hospital for Sick Children, Toronto, ON, Canada

    Jacqueline Flank & L. Lee Dupuis

  4. Division of Haematology/Oncology, Department of Paediatrics, The Hospital for Sick Children, Toronto, ON, Canada

    Lillian Sung

  5. Research Institute, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada

    Lillian Sung & L. Lee Dupuis

Authors
  1. Melissa Lau Moon Lin
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Correspondence to L. Lee Dupuis.

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Funding

Support of the Pediatric Oncology Group of Ontario to conduct the study and to prepare the manuscript is acknowledged. The funder did not influence the interpretation of the results of this work.

Conflict of interest

Melissa Lau Moon Lin, Paula D. Robinson, Jacqueline Flank, Lillian Sung, and L. Lee Dupuis have no conflicts of interest that are directly relevant to the content of this study.

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Lau Moon Lin, M., Robinson, P.D., Flank, J. et al. The Safety of Prochlorperazine in Children: A Systematic Review and Meta-Analysis. Drug Saf 39, 509–516 (2016). https://doi.org/10.1007/s40264-016-0398-9

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