A review on safety of metoclopramide in children
Bibliographic record
Abstract
Objective To evaluate the safety of metoclopramide in children. Methods Reports on clinical studies involving metoclopramide treament in children were searched at PubMed, Embase, Cochrane Library, CNKI, VIP, and Wanfang Database from inception to September 2014. Adverse drug reaction information bulletins and pharmacovigilance information related to metoclopramide were searched from China Food and Drug Administration (CFDA), US FDA, Health Canada, and European Medicines Agency (EMA). The relationship between the adverse reactions and metoclopramide were evaluated using evaluation criteria of WHO and the characteristics of adverse reactions were descriptively analyzed. Results A total of 54 articles in accordance with inclusion criteria were entered in this study. No RCT was included. A total of 646 cases of adverse reactions were reported in the 54 articles. Of them, 42 cases of adverse reactions in the 29 case reports were reported and 604 cases in the 25 case series reports were reported. In the 646 children, 352 cases were males and 284 were females with ages from 2 months to 18 years old, of them, 174 cases (26.9%) were 14 years. Among the 42 cases of adverse reactions, 29 cases had extrapyramidal reactions; 4 cases had gynecomastia; 2 cases had nausea syndrome and apnoea, respectively; 1 case had hyperaldosteronism, skin rashes, blood pressure increase, and circulatory failure, respectively; 39 cases were cured, 2 cases were improved but sequelae remained, and 1 case was transferred to other hospital for treatment. All adverse reactions among the 604 cases of adverse drug reactions in the 25 case series reports were extrapyramidal reactions, all patients were cured without sequela. It was reported that 16 cases of 58 cases with adverse reactions in 2008 CFDA Bulletins were children. In 2011 and 2009, the FDA and Health Canada warned that long-term or large doses of metoclopramide could cause tardive dyskinesia. In 2013, the EMA recommended that metoclopramide was limited to short-term use (≤5 d), should not be applied to children under 1 year of age and only as second-line drugs for the prevention of nausea and vomiting in chemotherapy and postoperative treatments in children >1 year of age. Conclusion The risks of extrapyramidal reactions and other serious adverse reactions existed in children with conventional dose of metoclopramide. Key words: Metoclopramide; Child; Safety
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.009 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.006 | 0.006 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".