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Drug therapy
Safety of ceftriaxone in paediatrics: a systematic review
  1. Linan Zeng1,2,
  2. Chao Wang3,
  3. Min Jiang4,
  4. Kexin Chen4,
  5. Haiqin Zhong4,
  6. Zhe Chen1,2,
  7. Liang Huang1,2,
  8. Hailong Li1,2,
  9. Lingli Zhang1,2,
  10. Imti Choonara5
  1. 1 Department of Pharmacy/Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China
  2. 2 Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China
  3. 3 Department of Pharmacy, Tianjin First Central Hospital, Tianjin, China
  4. 4 West China School of Pharmacy, Sichuan University, Chengdu, China
  5. 5 Academic Division of Child Health, Derbyshire Childrens Hospital, Derby, UK
  1. Correspondence to Professor Lingli Zhang, Department of Pharmacy/Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China; zhanglingli{at}scu.edu.cn

Abstract

Objective To determine the safety of ceftriaxone in paediatric patients and systematically evaluate the categories and incidences of adverse drug reactions (ADRs) of ceftriaxone in paediatric patients.

Methods We performed a systematic search in Medline, PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, International Pharmaceutical Abstracts and bibliographies of relevant articles up to December 2018 for all types of studies that assessed the safety of ceftriaxone in paediatric patients aged ≤18 years.

Results 112 studies met the inclusion criteria involving 5717 paediatric patients who received ceftriaxone and reported 1136 ADRs. The most frequent ADRs reported in prospective studies were gastrointestinal (GI) disorders (37.4 %, 292/780), followed by hepatobiliary disorders (24.6%, 192/780). Serious ADRs leading to withdrawal or discontinuation of ceftriaxone were reported in 86 paediatric patients. Immune haemolytic anaemia (34.9%, 30/86) and biliary pseudolithiasis (26.7%, 23/86) were the two major causes. Haemolytic anaemia following intravenous ceftriaxone led to death in 11 children whose primary disease was sickle cell disease. Almost all biliary pseudolithiasis are reversible. However, the incidence was high affecting one in five paediatric patients (20.7%).

Conclusions GI ADRs are the most common toxicity of ceftriaxone in paediatric patients. Immune haemolytic anaemia and biliary pseudolithiasis are the most serious ADRs and the major reasons for discontinuation of ceftriaxone. Immune haemolytic anaemia is more likely in children with sickle cell disease and may cause death. Ceftriaxone should be used with caution in children with sickle cell disease.

Trial registration number CRD42017055428

  • evidence based medicine
  • infectious diseases
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/archdischild-2019-317950

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    Footnotes

    • Contributors LNZ, IC and LLZ drafted the initial protocol; CW, MJ, KC, HZ, ZC and LH screened the literature and abstracted the data; LNZ and HL solved the discrepancy from the literature screening and data abstraction; LNZ drafted the initial paper; IC and LLZ revised the paper; and all the authors approved the final version.

    • Funding This study was funded by Key Program of Science and Technology Agency, Sichuan Province (No. 2017JY0067).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available in a public, open access repository. Data are available on reasonable request. Data may be obtained from a third party and are not publicly available. All data relevant to the study are included in the article or uploaded as supplementary information. Data of the individual studies are available on reasonable request.