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Drug-Induced Liver Injury Associated With Antidepressive Psychopharmacotherapy: An Explorative Assessment Based on Quantitative Signal Detection Using Different MedDRA Terms.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Gahr, Maximilian Zeiss, René Lang, Dirk Connemann, Bernhard J. Hiemke, Christoph Schönfeldt-Lecuona, Carlos
Description	Country affiliation: Germany Author Affiliation: Gahr M ( University of Ulm, Department of Psychiatry and Psychotherapy III, Ulm, Germany.); Zeiss R ( University of Ulm, Department of Psychiatry and Psychotherapy III, Ulm, Germany.); Lang D ( University of Ulm, Department of Psychosomatic Medicine and Psychotherapy, Ulm, Germany.); Connemann BJ ( University of Ulm, Department of Psychiatry and Psychotherapy III, Ulm, Germany.); Hiemke C ( University Medical Center of Mainz, Department of Psychiatry and Psychotherapy, Mainz, Germany.); Schönfeldt-Lecuona C ( University of Ulm, Department of Psychiatry and Psychotherapy III, Ulm, Germany.)
Abstract	Drug-induced liver injury is a major problem of pharmacotherapy and is also frequent with antidepressive psychopharmacotherapy. However, there are only few studies using a consistent methodologic approach to study hepatotoxicity of a larger group of antidepress ants. We performed a quantitative signal detection analysis using data from the Uppsala Monitoring Centre from the WHO that records adverse drug reaction (ADR) data from worldwide sources; we retrieved substance- and country-specific (Australia, France, Germany, Italy, Spain, the United Kingdom, and the United States) ADR data and calculated reporting odds ratios as measures for disproportionality within a case/noncase approach. To allow for identification of agents that cause severe forms of hepatotoxic ADRs, we used 2 terms of the MedDRA ('drug-related hepatic disorders-comprehensive search' [DRHD-CS] and ' -severe events only' [DRHD-SEO]). Distribution of signals was heterogeneous throughout the different data sets, and consistent findings were present for only a few substances: agomelatine (AGM) and tianeptine as well as both positive control agents (amineptine, nefazodone) generated signals related to DRHD-CS and DRHD-SEO in all analyzed data sets. Tri- and tetracyclic antidepressants (here amitriptyline, clomipramine, mianserin, mirtazapine, trimipramine) were associated with hepatotoxicity in several data sets. Using 2 MedDRA terms did not allow for detection of agents that cause severe hepatotoxic ADR. Our results support the findings of previous, primarily literature-based, systematic analyses of hepatotoxicity related to antidepressive psychopharmacotherapy. No new safety information could be generated. Application of 2 MedDRA terms did not increase the substance-specific safety information.
File Format	HTM / HTML
ISSN	00912700
Issue Number	6
Journal	The Journal of Clinical Pharmacology
Volume Number	56
e-ISSN	15524604
Language	English
Publisher	Wiley
Publisher Date	2016-06-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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