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

Drug Safety volume 37, pages 791–804 (2014)Cite this article

Abstract

Background

Olanzapine is frequently prescribed in young children for psychiatric conditions. It may be an option for chemotherapy-induced nausea and vomiting (CINV) control in children. The objective of this review was to describe the safety of olanzapine in children less than 13 years of age to determine if safety concerns would be a barrier to its use for CINV prevention.

Methods

Electronic searches were performed in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science and Scopus. All studies in English reporting adverse effects associated with olanzapine use in children younger than 13 years or with a mean/median age less than 13 years were included. Adverse outcomes were synthesized for prospective studies.

Results

A total of 47 studies (17 prospective) involving 387 children aged 0.6–18 years were included; nine described olanzapine poisonings. Weight gain or sedation were reported in 78 % [95 % confidence interval (CI) 63–95] and 48 % (95 % CI 35–67), respectively. Extrapyramidal symptoms or electrocardiogram abnormalities were reported in 9 % (95 % CI 4–21) and 14 % (95 % CI 7–26), respectively. Elevation in liver function tests or blood glucose abnormalities were reported in 7 % (95 % CI 2–20) and 4 % (95 % CI 1–17), respectively. No deaths were attributed to olanzapine.

Limitations

No studies were identified with a primary focus on evaluating safety, and the adverse effects reported in the included studies were heterogeneous.

Conclusions

Most adverse events associated with olanzapine use in children less than 13 years of age are of minor clinical significance. These findings support the exploration of olanzapine for the prevention of CINV in children in future trials.

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Acknowledgments

We would like to thank Thomasin Adams-Webber (Systems and Clinical Services Librarian, The Hospital for Sick Children) for her assistance with completion of the literature search.

Funding and Conflicts of Interest

No sources of funding were used to assist in the preparation of this study. Jacqueline Flank, Lillian Sung, Christopher Dvorak, Wendy Spettigue and L. Lee Dupuis have no conflicts of interest that are directly relevant to the content of this study.

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Authors and Affiliations

  1. Department of Pharmaceutical Sciences and Department of Pharmacy, Leslie Dan Faculty of Pharmacy, University of Toronto and The Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8, Canada

    Jacqueline Flank

  2. Division of Haematology/Oncology, Research Institute and Department of Pediatrics, The Hospital for Sick Children, 686 Bay Street, Toronto, ON, M5G 0A4, Canada

    Lillian Sung

  3. Division of Pediatric Allergy, Immunology and Bone Marrow Transplantation, University of California at San Francisco, 505 Parnassus Avenue, San Francisco, CA, 94143, USA

    Christopher C. Dvorak

  4. Division of Psychiatry, Department of Pediatrics, Children’s Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada

    Wendy Spettigue

  5. Research Institute and Department of Pharmacy, The Hospital for Sick Children, Leslie Dan Faculty of Pharmacy, University of Toronto, 686 Bay Street, Toronto, ON, M5G 0A4, Canada

    L. Lee Dupuis

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  1. Jacqueline Flank
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  2. Lillian Sung
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Correspondence to Jacqueline Flank.

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Flank, J., Sung, L., Dvorak, C.C. et al. The Safety of Olanzapine in Young Children: A Systematic Review and Meta-Analysis. Drug Saf 37, 791–804 (2014). https://doi.org/10.1007/s40264-014-0219-y

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Keywords

  • Olanzapine
  • Tardive Dyskinesia
  • Neuroleptic Malignant Syndrome
  • Paediatric Cancer Patient
  • Atypical Antipsychotic Agent