The safety of olanzapine in young children: a systematic review and meta-analysis
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Published on: November 21, 2013
Jacqueline Flank1, Lillian Sung, Christopher C Dvorak
1Department 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@sickkids.ca.
Insights
Olanzapine use in children under 13 for chemotherapy-induced nausea and vomiting (CINV) shows mostly minor side effects like weight gain and sedation. These findings support further trials for CINV prevention in pediatric patients.
Area of Science:
- Pediatric pharmacology
- Oncology supportive care
- Clinical toxicology
Background:
- Olanzapine is commonly prescribed for psychiatric conditions in children.
- Its potential use for chemotherapy-induced nausea and vomiting (CINV) in pediatric patients warrants safety evaluation.
- This review assesses olanzapine's safety profile in children under 13 for CINV prevention.
Purpose of the Study:
- To review the safety of olanzapine in children younger than 13 years.
- To determine if safety concerns preclude its use for CINV prevention in this age group.
Main Methods:
- Comprehensive electronic searches across major biomedical databases (MEDLINE, EMBASE, Cochrane, Web of Science, Scopus).
- Inclusion of all English-language studies reporting adverse effects of olanzapine in children under 13.
- Synthesis of adverse outcomes from prospective studies.
Main Results:
- 47 studies (17 prospective) involving 387 children were analyzed.
- Common adverse events included weight gain (78%) and sedation (48%).
- Other reported events: extrapyramidal symptoms (9%), ECG abnormalities (14%), elevated liver function tests (7%), and blood glucose abnormalities (4%). No deaths were reported.
Conclusions:
- Most olanzapine-associated adverse events in children under 13 are of minor clinical significance.
- The safety profile appears acceptable for exploring olanzapine in CINV prevention trials.
- Further research is needed to confirm efficacy and safety in pediatric CINV management.
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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