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Chang CC, Chen YJ, Chen YA, Liao YC. Acute Hepatitis Due to Agomelatine Use in Elderly Women with Depression: Case Series. CLINICAL PSYCHOPHARMACOLOGY AND NEUROSCIENCE 2021; 19:789-792. [PMID: 34690134 PMCID: PMC8553533 DOI: 10.9758/cpn.2021.19.4.789] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 12/08/2020] [Revised: 01/31/2021] [Accepted: 02/01/2021] [Indexed: 12/24/2022]
Abstract
Although agomelatine may be associated with an increased risk of hepatotoxicity, the incidence rate of acute hepatitis seemed divergent between clinical trials and daily practice. Whether aging or gender is a risk factor in developing hepatotoxicity due to agomelatine is not clear. We present 3 older female cases with acute hepatitis occurring due to highly probable idiosyncratic drug-induced liver injury caused by agomelatine. From these cases, regular surveillance on liver function in the older women taking antidepressants would be of benefits.
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Affiliation(s)
- Cheng-Chen Chang
- Department of Psychiatry, Changhua Christian Hospital, Changhua, Taiwan
- School of Medicine, Chung Shan Medical University, Taichung, Taiwan
| | - Yen-Jen Chen
- Department of Psychiatry, Changhua Christian Hospital, Changhua, Taiwan
| | - Yu-An Chen
- Department of Psychiatry, Changhua Christian Hospital, Changhua, Taiwan
| | - Yi-Cheng Liao
- Department of Psychiatry, Changhua Christian Hospital, Changhua, Taiwan
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Abstract
INTRODUCTION Agomelatine is an antidepressant with unique pharmacological actions; it is both a melatonin agonist and selective serotonin antagonist. Both actions combined are necessary for antidepressant efficacy. Effects on melatonin receptors enable resynchronisation of disrupted circadian rhythms with beneficial effects on sleep patterns. Areas covered: The issue of use of an antidepressant for depression co-morbid with somatic disorders is covered by the authors. A review of the literature from 2000 to August 2018 was undertaken using Scopus and Web of Science with the key words: agomelatine, depression, medical illness. Depression in Parkinson's disease, cardiovascular illness and type II diabetes is reviewed with evidence of efficacy. Bipolar depression and seasonal affective disorder may also react favourably. Agomelatine may have specific efficacy on symptoms of anhedonia. Expert opinion: Despite approval in some major jurisdictions, the drug has failed to gain registration in the United States. A defining issue may be questions about longer term efficacy: unequivocal effectiveness in placebo-controlled relapse prevention studies has not always been demonstrated. Continuation studies suggest maintenance of clinical responsiveness. A major disadvantage of the drug is its' potential hepatotoxicity and the need for repeated clinical laboratory tests.
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Affiliation(s)
- Trevor R Norman
- a Department of Psychiatry , University of Melbourne, Austin Hospital , Heidelberg , Australia
| | - James S Olver
- a Department of Psychiatry , University of Melbourne, Austin Hospital , Heidelberg , Australia
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Wang SM, Han C, Bahk WM, Lee SJ, Patkar AA, Masand PS, Pae CU. Addressing the Side Effects of Contemporary Antidepressant Drugs: A Comprehensive Review. Chonnam Med J 2018; 54:101-112. [PMID: 29854675 PMCID: PMC5972123 DOI: 10.4068/cmj.2018.54.2.101] [Citation(s) in RCA: 165] [Impact Index Per Article: 23.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/12/2018] [Revised: 05/09/2018] [Accepted: 05/10/2018] [Indexed: 01/19/2023] Open
Abstract
Randomized trials have shown that selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) have better safety profiles than classical tricyclic antidepressants (TCAs). However, an increasing number of studies, including meta-analyses, naturalistic studies, and longer-term studies suggested that SSRIs and SNRIs are no less safe than TCAs. We focused on comparing the common side effects of TCAs with those of newer generation antidepressants including SSRIs, SNRIs, mirtazapine, and bupropion. The main purpose was to investigate safety profile differences among drug classes rather than the individual antidepressants, so studies containing comparison data on drug groups were prioritized. In terms of safety after overdose, the common belief on newer generation antidepressants having fewer side effects than TCAs appears to be true. TCAs were also associated with higher drop-out rates, lower tolerability, and higher cardiac side-effects. However, evidence regarding side effects including dry mouth, gastrointestinal side effects, hepatotoxicity, seizure, and weight has been inconsistent, some studies demonstrated the superiority of SSRIs and SNRIs over TCAs, while others found the opposite. Some other side effects such as sexual dysfunction, bleeding, and hyponatremia were more prominent with either SSRIs or SNRIs.
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Affiliation(s)
- Sheng-Min Wang
- Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Korea.,International Health Care Center, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Changsu Han
- Department of Psychiatry, Korea University, College of Medicine, Seoul, Korea
| | - Won-Myoung Bahk
- Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Korea
| | - Soo-Jung Lee
- Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Korea
| | - Ashwin A Patkar
- Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA
| | | | - Chi-Un Pae
- Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Korea.,Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.,Cell Death Disease Research Center, College of Medicine, The Catholic University of Korea, Seoul, Korea
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Billioti de Gage S, Collin C, Le-Tri T, Pariente A, Bégaud B, Verdoux H, Dray-Spira R, Zureik M. Antidepressants and Hepatotoxicity: A Cohort Study among 5 Million Individuals Registered in the French National Health Insurance Database. CNS Drugs 2018; 32:673-684. [PMID: 29959758 PMCID: PMC6061298 DOI: 10.1007/s40263-018-0537-1] [Citation(s) in RCA: 30] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/28/2023]
Abstract
BACKGROUND Hepatotoxicity may be a concern when prescribing antidepressants. Nevertheless, this risk remains poorly understood for serotonin and noradrenaline reuptake inhibitors (SNRIs: venlafaxine, milnacipran, duloxetine) and 'other antidepressants' (mianserin, mirtazapine, tianeptine and agomelatine), particularly in comparison with selective serotonin reuptake inhibitors (SSRIs: fluoxetine, citalopram, paroxetine, sertraline, fluvoxamine, escitalopram), which are by far the most commonly prescribed antidepressants. OBJECTIVE We quantified the risk of serious liver injury associated with new use of SNRIs and 'other antidepressants' compared with SSRIs in real-life practice. METHODS Based on the French national health insurance database, this cohort study included 4,966,825 individuals aged 25 years and older with a first reimbursement of SSRIs, SNRIs or 'other antidepressants' between January 2010 and June 2015. We compared the risk of serious liver injury within the 6 months following antidepressant initiation according to antidepressant class, with SSRIs as the reference, using an inverse probability-of-treatment-weighted Cox proportional hazard model adjusted for demographic characteristics and risk factors of liver injury. RESULTS We identified 382 serious liver injuries overall (none for milnacipran initiators). Age and gender standardized incidence rates per 100,000 person-years were 19.2 for SSRIs, 22.2 for venlafaxine, 12.6 for duloxetine, 21.5 for mianserin, 32.8 for mirtazapine, 31.6 for tianeptine and 24.6 for agomelatine initiators. Initiation of antidepressants of interest versus SSRIs was not associated with an increased risk of serious liver injury [adjusted hazard ratios (95% confidence interval): venlafaxine 1.17 (0.83-1.64), duloxetine 0.54 (0.28-1.02), mianserin 0.90 (0.58-1.41), mirtazapine 1.17 (0.67-2.02), tianeptine 1.35 (0.82-2.23) and agomelatine 1.07 (0.51-2.23)]. This finding was confirmed by the results of an additional study using a case-time-control design. CONCLUSION These results do not provide evidence of an increased risk of serious liver injury following initiation of SNRIs or 'other antidepressants' compared with SSRIs in real-life practice. This could reflect an inherent lack of difference in risk between the drug classes, or the fact that individuals with higher susceptibility to drug-induced liver injury are not prescribed drugs considered to be more hepatotoxic.
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Affiliation(s)
- Sophie Billioti de Gage
- Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), 143-147 Blvd Anatole France, 93285 Saint-Denis, France ,0000 0001 2106 639Xgrid.412041.2University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219, 33000 Bordeaux, France
| | - Cédric Collin
- Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), 143-147 Blvd Anatole France, 93285 Saint-Denis, France
| | - Thien Le-Tri
- Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), 143-147 Blvd Anatole France, 93285 Saint-Denis, France
| | - Antoine Pariente
- 0000 0001 2106 639Xgrid.412041.2University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219, 33000 Bordeaux, France
| | - Bernard Bégaud
- 0000 0001 2106 639Xgrid.412041.2University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219, 33000 Bordeaux, France
| | - Hélène Verdoux
- 0000 0001 2106 639Xgrid.412041.2University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219, 33000 Bordeaux, France ,Pôle UNIVA (UNIVersitaire de psychiatrie Adulte), Centre Hospitalier Charles Perrens, 33000 Bordeaux, France
| | - Rosemary Dray-Spira
- Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), 143-147 Blvd Anatole France, 93285 Saint-Denis, France
| | - Mahmoud Zureik
- Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), 143-147 Blvd Anatole France, 93285, Saint-Denis, France. .,University of Versailles Saint-Quentin-en-Yvelines, 78180, Montigny-Le-Bretonneux, France.
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Telles-Correia D, Barbosa A, Cortez-Pinto H, Campos C, Rocha NBF, Machado S. Psychotropic drugs and liver disease: A critical review of pharmacokinetics and liver toxicity. World J Gastrointest Pharmacol Ther 2017; 8:26-38. [PMID: 28217372 PMCID: PMC5292604 DOI: 10.4292/wjgpt.v8.i1.26] [Citation(s) in RCA: 68] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2016] [Revised: 11/02/2016] [Accepted: 11/16/2016] [Indexed: 02/06/2023] Open
Abstract
The liver is the organ by which the majority of substances are metabolized, including psychotropic drugs. There are several pharmacokinetic changes in end-stage liver disease that can interfere with the metabolization of psychotropic drugs. This fact is particularly true in drugs with extensive first-pass metabolism, highly protein bound drugs and drugs depending on phase I hepatic metabolic reactions. Psychopharmacological agents are also associated with a risk of hepatotoxicity. The evidence is insufficient for definite conclusions regarding the prevalence and severity of psychiatric drug-induced liver injury. High-risk psychotropics are not advised when there is pre-existing liver disease, and after starting a psychotropic agent in a patient with hepatic impairment, frequent liver function/lesion monitoring is advised. The authors carefully review the pharmacokinetic disturbances induced by end-stage liver disease and the potential of psychopharmacological agents for liver toxicity.
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