Öz
Aim: The present study aims to evaluate the potential risk of ocular adverse events with vortioxetine use by analyzing real-world adverse events reported in the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) database.
Material and Method: The OpenVigil 2.1-MedDRA-v24 disproportionality analysis software package, including the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) algorithms, was used to determine the potential risk of ocular adverse events associated with vortioxetine and to determine signal strength. Ocular adverse event reports related to the generic name vortioxetine as the primary suspect in the FAERS database between 16 May 2014 and 30 September 2024 were included in this study. Risk signal strength for ROR and PRR were classified as low, medium and strong in line with the signal intensity.
Results: Twenty-nine ‘preferred terms’ with 3 or more reports were included in this study. Given the results of the disproportionality analysis, 5 adverse events with potential positive signals were found. These were halo vision (ROR=8.205, PRR=8.202; medium signal), angle-closure glaucoma (ROR=5.646, PRR=5.642; medium signal), blepharospasm (ROR=3.408, PRR=3.406; weak signal), oculogyric crisis (ROR=2.394, PRR=2.393; weak signal), and blurred vision (ROR=2.023, PRR=2.011; weak signal).
Conclusion: The disproportionality analysis conducted on the FAERS database revealed possible adverse events associated with vortioxetine in eye disorders and not documented in the drug’s package insert (except for angle-closure glaucoma). In conclusion, these findings indicate that continued post-marketing surveillance plays a decisive role in signaling potential new ocular adverse drug events.
Anahtar Kelimeler
Vortioxetine adverse event eye disorders disproportionality analysis
Etik Beyan
This research did not require ethics committee approval since the authors had no knowledge of data collection or the participants in the present study.
Kaynakça
- Bang-Andersen B, Ruhland T, Jørgensen M, et al. Discovery of 1- [2- (2,4-Dimethylphenylsulfanyl) phenyl] piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder. J Med Chem. 2011;54:3206-21.
- Cipriani A, Furukawa TA, Salanti G, et al. Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis. Lancet. 2018;391:1357-66.
- Lam RW, Kennedy SH, Adams C, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2023 Update on Clinical Guidelines for Management of Major Depressive Disorder in Adults: Réseau canadien pour les traitements de l’humeur et de l’anxiété (CANMAT) 2023: Mise à jour des lignes directrices cliniques pour la prise en charge du trouble dépressif majeur chez les adultes. Can J Psychiatry. 2024;69:641-87.
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- Salagre E, Grande I, Solé B, et al. Vortioxetina: una nueva alternativa en el trastorno depresivo mayor. Rev Psiquiatr Salud Ment. 2018;11:48-59.
- Carvalho AF, Sharma MS, Brunoni AR, et al. The safety, tolerability and risks associated with the use of newer generation antidepressant drugs: a critical review of the literature. Psychother Psychosom. 2016;85:270-88.
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- Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) Public Dashboard. https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard access date 06.01.2025.
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- Davis SE, Zabotka L, Desai RJ, et al. Use of electronic health record data for drug safety signal identification: a scoping review. Drug Saf. 2023;46:725-42.
- Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001;10:483-6.
- van Puijenbroek EP, Bate A, Leufkens HGM, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002;11:3-10.
- Böhm R, von Hehn L, Herdegen T, et al. OpenVigil FDA – inspection of U.S. American adverse drug events pharmacovigilance data and novel clinical applications. PLoS One. 2016;11:e0157753.
- Pan Y, Wang Y, Zheng Y, et al. A disproportionality analysis of FDA adverse event reporting system (FAERS) events for ticagrelor. Front Pharmacol. 2024;15:1251961.
- Pula JH, Kao AM, Kattah JC. Neuro-ophthalmologic side-effects of systemic medications. Curr Opin Ophthalmol. 2013;24:540-9.
- Richa S, Yazbek JC. Ocular adverse effects of common psychotropic agents. CNS Drugs. 2010;24:501-26.
- Aftab OM, Khan H, Khouri AS. Blind spots in therapy: unveiling drug-induced angle-closure glaucoma through a national analysis. Ophthalmol Glaucoma. 2024;7:485-90.
- Wu A, Khawaja AP, Pasquale LR, Stein JD. A review of systemic medications that may modulate the risk of glaucoma. Eye (Lond). 2020;34:12-28.
- Kirkham J, Seitz D. Evidence of ocular side effects of SSRIs and new warnings. Evidence Based Mental Health. 2017;20:27.
- Tripathi RC, Tripathi BJ, Haggerty C. Drug-induced glaucomas. Drug Saf. 2003;26:749-67.
- Huillard O, Bakalian S, Levy C, et al. Ocular adverse events of molecularly targeted agents approved in solid tumours: a systematic review. Eur J Cancer. 2014;50:638-48.
- Zhou Q, Li X, Yang D, et al . A comprehensive review and meta-analysis of neurological side effects related to second-generation antidepressants in individuals with major depressive disorder. Behavioural Brain Research. 2023;447:114431.
- Mao K, Chen P, Sun H, et al. Ocular adverse events associated with antibody-drug conjugates in oncology: a pharmacovigilance study based on FDA adverse event reporting system (FAERS). Front Pharmacol. 2024;15:1425617.
- Syed MF, Rehmani A, Yang M. Ocular side effects of common systemic medications and systemic side effects of ocular medications. Med Clin North Am. 2021;105:425-44.
- Mu C, Chen L. Characteristics of eye disorders induced by atypical antipsychotics: a real-world study from 2016 to 2022 based on food and drug administration adverse event reporting system. Front Psychiatry. 2024;15:1322939.
- Yuko Emoto. Twelve cases of drug-induced blepharospasm improved within 2 months of psychotropic cessation. Drug Healthc Patient Saf. 2011;3:9-14.
- Mahal P, Suthar N, Nebhinani N. Spotlight on oculogyric crisis: a review. Indian J Psychol Med. 2021;43:5-9.
- Zhu H, Qu Y, Du Z, et al. Mining and analysis of adverse event signals of Cariprazine based on the real-world data of FAERS database. J Affect Disord. 2024;347:45-50.
- U. S. Food and Drug Aadministration (FDA). Takeda Pharmaceuticals America, Inc. 2021 Trintellix® Full Prescription Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s021s022lbl.pdf access date 05.01.2025.
- Food and Drug Administration (FDA). Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER). https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=381 access date 05.01.2025.
Öz
Kaynakça
- Bang-Andersen B, Ruhland T, Jørgensen M, et al. Discovery of 1- [2- (2,4-Dimethylphenylsulfanyl) phenyl] piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder. J Med Chem. 2011;54:3206-21.
- Cipriani A, Furukawa TA, Salanti G, et al. Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis. Lancet. 2018;391:1357-66.
- Lam RW, Kennedy SH, Adams C, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2023 Update on Clinical Guidelines for Management of Major Depressive Disorder in Adults: Réseau canadien pour les traitements de l’humeur et de l’anxiété (CANMAT) 2023: Mise à jour des lignes directrices cliniques pour la prise en charge du trouble dépressif majeur chez les adultes. Can J Psychiatry. 2024;69:641-87.
- Tran BX, Ha GH, Vu GT, et al. Indices of change, expectations, and popularity of biological treatments for major depressive disorder between 1988 and 2017: a scientometric analysis. Int J Environ Res Public Health. 2019;16:2255.
- Salagre E, Grande I, Solé B, et al. Vortioxetina: una nueva alternativa en el trastorno depresivo mayor. Rev Psiquiatr Salud Ment. 2018;11:48-59.
- Carvalho AF, Sharma MS, Brunoni AR, et al. The safety, tolerability and risks associated with the use of newer generation antidepressant drugs: a critical review of the literature. Psychother Psychosom. 2016;85:270-88.
- Kommu S, Carter C, Whitfield P. Adverse drug reactions. 2024 Jan 10. In: StatPearls [Internet].
- Wu SN, Huang C, Wang YQ, et al. Adverse events of topical ocular prostaglandin medications for glaucoma treatment: a pharmacovigilance study based on the FAERS database. Ther Adv Drug Saf. 2024;15:20420986241285930.
- Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) Public Dashboard. https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard access date 06.01.2025.
- Salvo F, Raschi E, Moretti U, et al. Pharmacological prioritisation of signals of disproportionate reporting: proposal of an algorithm and pilot evaluation. Eur J Clin Pharmacol. 2014;70:617-25.
- Davis SE, Zabotka L, Desai RJ, et al. Use of electronic health record data for drug safety signal identification: a scoping review. Drug Saf. 2023;46:725-42.
- Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001;10:483-6.
- van Puijenbroek EP, Bate A, Leufkens HGM, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002;11:3-10.
- Böhm R, von Hehn L, Herdegen T, et al. OpenVigil FDA – inspection of U.S. American adverse drug events pharmacovigilance data and novel clinical applications. PLoS One. 2016;11:e0157753.
- Pan Y, Wang Y, Zheng Y, et al. A disproportionality analysis of FDA adverse event reporting system (FAERS) events for ticagrelor. Front Pharmacol. 2024;15:1251961.
- Pula JH, Kao AM, Kattah JC. Neuro-ophthalmologic side-effects of systemic medications. Curr Opin Ophthalmol. 2013;24:540-9.
- Richa S, Yazbek JC. Ocular adverse effects of common psychotropic agents. CNS Drugs. 2010;24:501-26.
- Aftab OM, Khan H, Khouri AS. Blind spots in therapy: unveiling drug-induced angle-closure glaucoma through a national analysis. Ophthalmol Glaucoma. 2024;7:485-90.
- Wu A, Khawaja AP, Pasquale LR, Stein JD. A review of systemic medications that may modulate the risk of glaucoma. Eye (Lond). 2020;34:12-28.
- Kirkham J, Seitz D. Evidence of ocular side effects of SSRIs and new warnings. Evidence Based Mental Health. 2017;20:27.
- Tripathi RC, Tripathi BJ, Haggerty C. Drug-induced glaucomas. Drug Saf. 2003;26:749-67.
- Huillard O, Bakalian S, Levy C, et al. Ocular adverse events of molecularly targeted agents approved in solid tumours: a systematic review. Eur J Cancer. 2014;50:638-48.
- Zhou Q, Li X, Yang D, et al . A comprehensive review and meta-analysis of neurological side effects related to second-generation antidepressants in individuals with major depressive disorder. Behavioural Brain Research. 2023;447:114431.
- Mao K, Chen P, Sun H, et al. Ocular adverse events associated with antibody-drug conjugates in oncology: a pharmacovigilance study based on FDA adverse event reporting system (FAERS). Front Pharmacol. 2024;15:1425617.
- Syed MF, Rehmani A, Yang M. Ocular side effects of common systemic medications and systemic side effects of ocular medications. Med Clin North Am. 2021;105:425-44.
- Mu C, Chen L. Characteristics of eye disorders induced by atypical antipsychotics: a real-world study from 2016 to 2022 based on food and drug administration adverse event reporting system. Front Psychiatry. 2024;15:1322939.
- Yuko Emoto. Twelve cases of drug-induced blepharospasm improved within 2 months of psychotropic cessation. Drug Healthc Patient Saf. 2011;3:9-14.
- Mahal P, Suthar N, Nebhinani N. Spotlight on oculogyric crisis: a review. Indian J Psychol Med. 2021;43:5-9.
- Zhu H, Qu Y, Du Z, et al. Mining and analysis of adverse event signals of Cariprazine based on the real-world data of FAERS database. J Affect Disord. 2024;347:45-50.
- U. S. Food and Drug Aadministration (FDA). Takeda Pharmaceuticals America, Inc. 2021 Trintellix® Full Prescription Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s021s022lbl.pdf access date 05.01.2025.
- Food and Drug Administration (FDA). Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER). https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=381 access date 05.01.2025.
Ayrıntılar
| Birincil Dil | İngilizce |
|---|---|
| Konular | Klinik Farmakoloji ve Terapötikler |
| Bölüm | Özgün Makaleler |
| Yazarlar | |
| Yayımlanma Tarihi | 9 Mayıs 2025 |
| Gönderilme Tarihi | 17 Şubat 2025 |
| Kabul Tarihi | 18 Nisan 2025 |
| Yayımlandığı Sayı | Yıl 2025 Cilt: 7 Sayı: 2 |
Chief Editors
Assoc. Prof. Zülal Öner
İzmir Bakırçay University, Department of Anatomy, İzmir, Türkiye
Assoc. Prof. Deniz Şenol
Düzce University, Department of Anatomy, Düzce, Türkiye
Editors
Assoc. Prof. Serkan Öner
İzmir Bakırçay University, Department of Radiology, İzmir, Türkiye
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