Analysis of the frequency of ceftriaxone-induced encephalopathy using the Japanese Adverse Drug Event Report database.
Adverse event
Cefotaxime
Ceftriaxone
Encephalopathy
Pharmacovigilance
Journal
International journal of clinical pharmacy
ISSN: 2210-7711
Titre abrégé: Int J Clin Pharm
Pays: Netherlands
ID NLM: 101554912
Informations de publication
Date de publication:
Aug 2022
Aug 2022
Historique:
received:
20
12
2021
accepted:
20
03
2022
revised:
16
03
2022
pubmed:
23
4
2022
medline:
24
8
2022
entrez:
22
4
2022
Statut:
ppublish
Résumé
The profile of ceftriaxone-induced encephalopathy is not well understood. To identify risk factors associated with ceftriaxone-induced encephalopathy. In this observational study, anonymised patient data were retrieved from the open-access Japanese Adverse Drug Event Report database for ceftriaxone users aged 20 years or higher. Data of 256,788 individuals and 12,160 cases of encephalopathy were extracted, and 2,939 ceftriaxone users, of whom 193 had encephalopathy, were identified. A disproportionate prevalence of encephalopathy was observed among the ceftriaxone users (reported odds ratio = 1.42; 95% confidence interval [CI] = 1.23-1.65; p < 0.001). Multivariate logistic regression analysis of 2,057 ceftriaxone users showed encephalopathy was associated with female sex (odds ratio [OR] = 1.52; 95% CI, 1.05-2.19; p = 0.027), chronic kidney disease (OR = 2.32; 95% CI, 1.47-3.67; p < 0.001), a ceftriaxone dosage of > 2 g/day (OR = 2.66; 95% CI, 1.66-4.26; p < 0.001), and a treatment duration of > 14 days (OR = 1.94; 95% CI, 1.21-3.11; p = 0.006). Patients with chronic kidney disease, receiving ceftriaxone at a dosage of > 2 g/day, being treated for over 14 days, and/or females may be at an increased risk of ceftriaxone-induced encephalopathy.
Sections du résumé
BACKGROUND
BACKGROUND
The profile of ceftriaxone-induced encephalopathy is not well understood.
AIM
OBJECTIVE
To identify risk factors associated with ceftriaxone-induced encephalopathy.
METHOD
METHODS
In this observational study, anonymised patient data were retrieved from the open-access Japanese Adverse Drug Event Report database for ceftriaxone users aged 20 years or higher.
RESULTS
RESULTS
Data of 256,788 individuals and 12,160 cases of encephalopathy were extracted, and 2,939 ceftriaxone users, of whom 193 had encephalopathy, were identified. A disproportionate prevalence of encephalopathy was observed among the ceftriaxone users (reported odds ratio = 1.42; 95% confidence interval [CI] = 1.23-1.65; p < 0.001). Multivariate logistic regression analysis of 2,057 ceftriaxone users showed encephalopathy was associated with female sex (odds ratio [OR] = 1.52; 95% CI, 1.05-2.19; p = 0.027), chronic kidney disease (OR = 2.32; 95% CI, 1.47-3.67; p < 0.001), a ceftriaxone dosage of > 2 g/day (OR = 2.66; 95% CI, 1.66-4.26; p < 0.001), and a treatment duration of > 14 days (OR = 1.94; 95% CI, 1.21-3.11; p = 0.006).
CONCLUSION
CONCLUSIONS
Patients with chronic kidney disease, receiving ceftriaxone at a dosage of > 2 g/day, being treated for over 14 days, and/or females may be at an increased risk of ceftriaxone-induced encephalopathy.
Identifiants
pubmed: 35449346
doi: 10.1007/s11096-022-01406-7
pii: 10.1007/s11096-022-01406-7
doi:
Substances chimiques
Anti-Bacterial Agents
0
Ceftriaxone
75J73V1629
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1067-1071Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
Références
Hansen N. Drug-induced encephalopathy. In: Tanasescu R, editor. Miscellanea on encephalopathies - A second look. IntechOpen.ISBN 978-953-51-0558-9; 2012. p. 39–61.
Deshayes S, Coquerel A, Verdon R. Neurological adverse effects attributable to β-lactam antibiotics: a literature review. Drug Saf. 2017;40:1171–98.
doi: 10.1007/s40264-017-0578-2
Singh TD, O’Horo JC, Day CN, et al. Cefepime is associated with acute encephalopathy in critically ill patients: a retrospective case-control study. Neurocrit Care. 2020;33:695–700. https://doi.org/10.1007/s12028-020-01035-w .
doi: 10.1007/s12028-020-01035-w
Gilbert DN, Chambers HF, Eliopoulos GM, et al. The Sanford guide to antimicrobial therapy 2018. 48th ed. Sperryville, VA: Antimicrobial Therapy, Incorp. ISBN 9781944272081; 2018.
Sutter R, Rüegg S, Tschudin-Sutter S. Seizures as adverse events of antibiotic drugs: a systematic review. Neurology. 2015;85:1332–41. https://doi.org/10.1212/WNL.0000000000002023 .
doi: 10.1212/WNL.0000000000002023
Lacroix C, Bera-Jonville AP, Montastruc F, et al. Serious neurological adverse events of ceftriaxone. Antibiot (Basel). 2021;10:540. https://doi.org/10.3390/antibiotics10050540 .
doi: 10.3390/antibiotics10050540
Pharmaceuticals and Medical Devices Agency. http://www.pmda.go.jp/ . Accessed 9 Dec, 2020.
Pharmaceutical and Medical Device Regulatory Science Society of Japan. MedDRA Japanese maintenance organization. https://www.jmo.pmrj.jp/ . Accessed 23 Sep, 2021.
Bate A, Evans SJ. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf. 2009;18:427–36.
doi: 10.1002/pds.1742
Uchida H, Sakaguchi T, Hongo I, et al. A case of antibiotic-associated encephalopathy with very high blood concentrations of ceftriaxone in a low-body-weight patient on hemodialysis. Jpn J Chemother. 2021;69:433–9.
Simon N, Dussol B, Sampol E, et al. Population pharmacokinetics of ceftriaxone and pharmacodynamic considerations in haemodialysed patients. Clin Pharmacokinet. 2006;45:493–501.
doi: 10.2165/00003088-200645050-00004
Lacroix C, Kheloufi F, Montastruc F, et al. Serious central nervous system side effects of cephalosporins: a national analysis of serious reports registered in the French pharmacovigilance Database. J Neurol Sci. 2019;398:196–201.
doi: 10.1016/j.jns.2019.01.018