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

Metoclopramide is recommended for adults with breakthrough or refractory chemotherapy-induced nausea and vomiting (CINV) and for CINV prophylaxis in children. The drug regulatory agencies of Canada and the EU have revised the labelling of metoclopramide to contraindicate its use in children aged <1 year and to caution against its use in children aged <5 years and its duration of use beyond 5 days.

This review describes the safety of metoclopramide in children when given for any indication.

We conducted electronic searches in MEDLINE and Embase as of 9 March 2015. All studies in English reporting adverse effects associated with the use of metoclopramide in children (aged ≤18 years) were included. Adverse effects that had a cumulative incidence of at least 1 % and were reported in prospective studies were synthesized.

A total of 108 (57 prospective) studies involving 2699 patients (2745 metoclopramide courses) were included. The most common adverse effects reported in prospective studies of metoclopramide in children were extrapyramidal symptoms (EPS; 9 %, 95 % confidence interval [CI] 5-17), diarrhea (6 %, 95 % CI 4-9), and sedation (multiple-dose studies: 6 %, 95 % CI 3-12). Dysrhythmia, respiratory distress/arrest, neuroleptic malignant syndrome, and tardive dyskinesia were rarely associated with metoclopramide use.

The definitions of adverse effects reported in the included studies were heterogeneous, and the risk of bias in most studies was moderate.

The most commonly reported adverse effects associated with the use of metoclopramide in children-EPS, diarrhea, and sedation-were reversible and of no long-term significance. Adverse effects that were life threatening or slow to resolve were rarely associated with its use in children.