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Sipos M, Farcas A, Leucuta DC, et al. Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly. Pharmaceuticals (Basel). 2021;14(5)doi: 10.3390/ph14050441.
Sipos, M., Farcas, A., Leucuta, D. C., Bucsa, C., Huruba, M., & Mogosan, C. (2021). Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly. Pharmaceuticals (Basel, Switzerland), 14(5), . https://doi.org/10.3390/ph14050441
Sipos, Mariana, et al. "Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly." Pharmaceuticals (Basel, Switzerland) vol. 14,5 (2021). doi: https://doi.org/10.3390/ph14050441
Sipos M, Farcas A, Leucuta DC, Bucsa C, Huruba M, Mogosan C. Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly. Pharmaceuticals (Basel). 2021 May 07;14(5). doi: 10.3390/ph14050441. PMID: 34067178; PMCID: PMC8151124.
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Pharmaceuticals (Basel). 2021 May 07;14(5). doi: 10.3390/ph14050441.

Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly.

Pharmaceuticals (Basel, Switzerland)

Mariana Sipos, Andreea Farcas, Daniel Corneliu Leucuta, Camelia Bucsa, Madalina Huruba, Cristina Mogosan

Affiliations

  1. Department of Pharmacology, Physiology and Physiopathology, Faculty of Pharmacy, "Iuliu Ha?ieganu" University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania.
  2. Drug Information Research Center, "Iuliu Hatieganu" University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania.
  3. Department of Medical Informatics and Biostatistics, "Iuliu Hatieganu" University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania.

PMID: 34067178 PMCID: PMC8151124 DOI: 10.3390/ph14050441

Abstract

BACKGROUND: The objective of this study was to characterize individual case safety reports (ICSRs) and adverse drug reactions (ADRs) related to second-generation cephalosporins and resulting in hepatobiliary disorders, in VigiBase, WHO global database.

METHODS: All second-generation cephalosporins hepatobiliary ADRs reported up to July 2019 were included. Characteristic of cephalosporins and ADRs, aside from disproportionality data were evaluated.

RESULTS: A total of 1343 ICSRs containing 1585 ADRs were analyzed. Cefuroxime was suspected to have caused hepatobiliary disorders in most cases-in 38% of adults and in 35% of elderly. Abnormal hepatic function was the most frequent ADR, followed by jaundice and hepatitis. For 49% of the ADRs reported in the elderly and 51% in the adult population, the outcome was favorable, with fatal outcome for 2% of the adults and 10% of the elderly. Higher proportional reporting ration (PRR) values were reported in the elderly for cefotetan-associated jaundice, cefuroxime-associated acute hepatitis and hepatitis cholestatic as well as for cefotiam and cefmetazole-associated liver disorder.

CONCLUSION: Hepatobiliary ADRs were reported for 2nd generation cephalosporins, with over 50% of cases in adults, without gender differences. Cholestatic hepatitis was predominately reported in the elderly and this category was more prone to specific hepatic reactions.

Keywords: VigiBase; adverse drug reaction; cephalosporins; hepatotoxicity

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