Ceftriaxone-Associated Biliary and Cardiopulmonary Adverse Events in Neonates: A Systematic Review of the Literature
Abstract
Background Ceftriaxone is a third-generation cephalosporin with broad-spectrum activity against both Gram-positive and Gram-negative bacteria. Despite its effectiveness, its use for the treatment of infections in neonatal patients has been limited because of concern about its potential toxicity. Objective Our aim was to review the literature for an association between ceftriaxone and cardiopulmonary events, hyperbilirubinemia, and pseudolithiasis among neonates. Methods We searched PubMed and EMBASE and included studies that evaluated ceftriaxone safety in neonates. Study bias was evaluated in the following domains: exposure measurement, outcome measurement, attrition, generalizability, confounding, statistical analysis, and reporting. Results We included nine studies regarding ceftriaxone side effects, primarily spontaneous reports, published case reports, and small case series. Reports of bilirubin displacement attributed to ceftriaxone included increases in serum bilirubin necessitating antibiotic change in a subset of infants after administration of ceftriaxone. One study described self-resolving biliary sludge after ceftriaxone administration in six of 80 infants. Cardiopulmonary adverse events included a report of eight cardiopulmonary events related to concomitant ceftriaxone-calcium infusion, including seven infant deaths. Additional cardiopulmonary events reported included perinatal asphyxia, pulmonary hypertension, and thrombocytosis. However, the available literatu…
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Ceftriaxone has the potential for physical binding to calcium salts when each is given intravenously.
“Fewer are likely to be familiar with the potential for physical binding of ceftriaxone to calcium salts when each is given intravenously [182] or that hydration status, which is for example commonly impaired in acute medical admissions [183], can affect drug enrichment [184].”
From ESPEN guideline on nutritional support for polymorbid medical inpatients (2023) · cites this paper as [182]
Cites
Vandenbroucke, J. P., von Elm, E., Altman, D. G., Gøtzsche, P. C., Mulrow, C. D., Pocock, S. J., Poole, C., Schlesselman, J. J., Egger, M., & Initiative, F. T. S. (2007) · PLoS Medicine · doi:10.1371/journal.pmed.0040297 · Cited by 8,613 · see citing works
Vandenbroucke, J. P., von Elm, E., Altman, D. G., Gøtzsche, P. C., Mulrow, C. D., Pocock, S. J., Poole, C., Schlesselman, J. J., & Egger, M. (2007) · Epidemiology · doi:10.1097/ede.0b013e3181577511 · Cited by 2,779 · see citing works
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ESPEN guidelines on nutritional support for polymorbid internal medicine patients
Gomes, F., Schuetz, P., Bounoure, L., Austin, P., Ballesteros-Pomar, M., Cederholm, T., Fletcher, J., Laviano, A., Norman, K., Poulia, K.-A., et al. (2018) · Clinical Nutrition · doi:10.1016/j.clnu.2017.06.025 · Cited by 363 · see citing works
ESPEN guideline on nutritional support for polymorbid medical inpatients
Wunderle, C., Gomes, F., Schuetz, P., Stumpf, F., Austin, P., Ballesteros-Pomar, M. D., Cederholm, T., Fletcher, J., Laviano, A., Norman, K., et al. (2023) · Clinical Nutrition · doi:10.1016/j.clnu.2023.06.023 · Cited by 105 · see citing works
“Fewer are likely to be familiar with the potential for physical binding of ceftriaxone to calcium salts when each is given intravenously [182] or that hydration status, which is for example commonly impaired in acute medical admissions [183], can affect drug enrichment [184].”
Background
- Authors
- Donnelly, P. C., Sutich, R. M., Easton, R., Adejumo, O. A., Lee, T. A., & Logan, L. K.
- Affiliations
- American Academy of Orthopaedic Surgeons (US)
- University of Illinois Chicago (US)
- Rush University Medical Center (US)
- Corresponding author
- Logan, Latania K.
- Venue
- Pediatric Drugs
- Published
- 2016-10-07
- Volume
- 19
- Issue
- 1
- Pages
- 21-34
- ISSN
- 1174-5878 (ISSN-L)
- 1179-2019
- OpenAlex
- W2528830994
- Cited by
- 46
- References
- 2
- Citations by year
- 2026: 5 · 2025: 5 · 2024: 7 · 2023: 6 · 2022: 3 · 2021: 3 · 2020: 6 · 2019: 1 · 2018: 3 · 2017: 5 · 2016: 1 · 2015: 1
- FWCI
- 0.52
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Pediatric Drugs (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of Allergy and Infectious Diseases (K08AI112506)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Pharmacology › Antibiotics Pharmacokinetics and Efficacy
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Neonatal Health and Biochemistry
- Keywords
- ceftriaxone, neonates, drug adverse events, hyperbilirubinemia, pseudolithiasis, biliary sludge, calcium infusion, drug safety, cephalosporins
- MeSH terms
- Anti-Bacterial Agents, Bilirubin, Ceftriaxone, Humans, Infant, Newborn, Administration, Intravenous
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