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Cited by 33Drug-Induced Hepatotoxicity and ProtectionPharmacovigilance and Adverse Drug ReactionsPoisoning and overdose treatments

Hepatotoxicity Related to Agomelatine and Other New Antidepressants: A Case/Noncase Approach With Information From the Portuguese, French, Spanish, and Italian Pharmacovigilance Systems

Montastruc, François, Scotto, Stefania, Vaz, Ines Ribeiro, Guerra, Leonor Nogueira, Escudero, Antonio, Sáinz, María, Falomir, Teresa, Bagheri, Haleh +4 more·2014·Journal of Clinical Psychopharmacology
DOI 10.1097/jcp.0000000000000094
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Abstract

Antidepressants have been associated with a low incidence of idiosyncratic hepatic injury. Some of them, nefazodone or amineptine, were observed to induce severe hepatic injury and withdrawn from the market. Recently, some cases of this severe condition have been reported in association with agomelatine use. Therefore, the objective of this study is to learn the risk of hepatic damage with agomelatine as compared with other new antidepressants. We took data from the Spanish, French, Italian, and Portuguese pharmacovigilance system databases. A case/noncase approach to assess the strength of the association between whichever antidepressant and hepatotoxicity was performed; cases were defined as reports of hepatotoxicity; noncases were reports of all reactions other than hepatotoxicity. Exposure was the recording of a new antidepressant in a report, whether or not it was suspected of causing the reaction. During the period surveyed, 3300 cases of hepatotoxicity were collected for the antidepressants assessed. They represent 10.3% of all cases collected for these drugs; the corresponding figure for all drugs was 6.0%. Meanwhile, 63 cases of hepatotoxicity associated with agomelatine were collected since its introduction until the end of the period studied; they account for a percentage of 14.6. Agomelatine was statistically associated with hepatotoxicity in Spain [reporting odds ratio (ROR), 4.9 (95% confidence interval [CI], 2.4-9.7)], France (ROR, 2.4 [95% CI, 1.5-3.7]), and Italy (ROR, 5.1 [95% CI, 1.7-14.0]). Current results support the idea of agomelatine to be related to a higher hepatotoxicity risk. Physicians should consider early discontinuation if the condition is suspected; health authorities should promptly explore the best regulatory actions to be taken.

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Authors
Montastruc, F., Scotto, S., Vaz, I. R., Guerra, L. N., Escudero, A., Sáinz, M., Falomir, T., Bagheri, H., Herdeiro, M. T., Venegoni, M., Montastruc, J. L., & Carvajal, A.
Affiliations
  • Universidad de Valladolid (ES)
  • Regione Lombardia (IT)
  • Infarmed (PT)
  • Inserm (FR)
Corresponding author
  • Montastruc, François
  • Bagheri, Haleh
  • Montastruc, Jean Louis
ORCID
Venue
Journal of Clinical Psychopharmacology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2014-06
Volume
34
Issue
3
Pages
327-330
ISSN
0271-0749 (ISSN-L)
DOI
10.1097/jcp.0000000000000094
OpenAlex
W1997078856
Cited by
33
References
21
Citations by year
2026: 1 · 2025: 2 · 2023: 1 · 2022: 1 · 2020: 3 · 2019: 6 · 2018: 1 · 2017: 7 · 2016: 2 · 2015: 7 · 2014: 2
FWCI
6.87
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Clinical Psychopharmacology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Emergency Medicine › Poisoning and overdose treatments
Keywords
agomelatine, hepatotoxicity, drug-induced liver injury, antidepressants, pharmacovigilance, adverse drug reactions, drug safety, reporting odds ratio
MeSH terms
Acetamides, Antidepressive Agents, France, Humans, Italy, Naphthalenes, Portugal, Spain, Incidence, Databases, Factual, Adverse Drug Reaction Reporting Systems, Chemical and Drug Induced Liver Injury, Pharmacovigilance

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