A systematic comparison of hepatobiliary adverse drug reactions in FDA and EMA drug labeling reveals discrepancies.
Adverse drug reactions
Contraindication
Drug labeling
Drug-induced liver injury
EMA
FDA
LiverTox
Warnings and precautions
Journal
Drug discovery today
ISSN: 1878-5832
Titre abrégé: Drug Discov Today
Pays: England
ID NLM: 9604391
Informations de publication
Date de publication:
01 2022
01 2022
Historique:
received:
12
05
2021
revised:
20
07
2021
accepted:
20
09
2021
pubmed:
5
10
2021
medline:
16
3
2022
entrez:
4
10
2021
Statut:
ppublish
Résumé
Drug labeling informs physicians and patients on the safe and effective use of medication. However, recent studies suggested discrepancies in labeling of the same drug between different regulatory agencies. Here, we evaluated the hepatic safety information in labeling for 549 medications approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Limited discrepancies were found regarding risk for hepatic adverse drug reactions (ADRs) (8.7% in hepatic ADR warnings and 21.3% in contraindication for liver disease), while caution should be exercised over drugs with inconsistencies in contraindications for liver disease and evidence for hepatotoxicity (4.9%). Most discrepancies were attributable to less-severe hepatic events and low-frequency hepatic ADR reports and had limited implication on clinical outcomes.
Identifiants
pubmed: 34607018
pii: S1359-6446(21)00403-7
doi: 10.1016/j.drudis.2021.09.009
pii:
doi:
Types de publication
Journal Article
Research Support, U.S. Gov't, P.H.S.
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
337-346Informations de copyright
Published by Elsevier Ltd.
Déclaration de conflit d'intérêts
Competing interests The authors have no conflicts to disclose.