Post-market safety profile and suicide/self-injury risk signals of dextromethorphan/bupropion: a real-world pharmacovigilance study.
Background: Dextromethorphan/bupropion (D/B) is an innovative pharmacological treatment for major depressive disorder. Nevertheless, the current evidence regarding the safety profile of D/B is predominantly derived from clinical trials, thus hindering the timely updating of adverse event (AE) data f...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 81; no. 7; pp. 1029 - 1042 |
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| Autores principales: | , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Jul2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=185843084&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 185843084 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Jul2025 vid: 81 iid: 7 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 185843084 184645957 185843084 185843084 10.1007/s00228-025-03841-7 185843084 ppf: 1029 ppct: 13 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Post-market safety profile and suicide/self-injury risk signals of dextromethorphan/bupropion: a real-world pharmacovigilance study. aug: au: Yuan, Lingjing He, Jianping Li, Xiangyu affil: https://ror.org/0269fty31 Shaoxing Second Hospital, Shaoxing, Zhejiang, China sug: subj: Suicide Psychosocial Factors Self-Injurious Behavior Chemically Induced Self-Injurious Behavior Epidemiology Dextromethorphan Adverse Effects Bupropion Adverse Effects Product Surveillance United States Food and Drug Administration Adverse Drug Event Data Mining Human Funding Source Male Female Child Adolescence Adult Middle Age Aged Aged, 80 and Over Descriptive Statistics Confidence Intervals Odds Ratio Mental Disorders Nervous System Diseases Age Factors Age of Onset Drug Labeling Panic Disorder Ketamine Adverse Effects Drug Combinations Resource Databases Child: 6-12 years Adolescent: 13-18 years Adult: 19-44 years Middle Aged: 45-64 years Aged: 65+ years Aged, 80 & over Male Female ab: Background: Dextromethorphan/bupropion (D/B) is an innovative pharmacological treatment for major depressive disorder. Nevertheless, the current evidence regarding the safety profile of D/B is predominantly derived from clinical trials, thus hindering the timely updating of adverse event (AE) data for this medication. Therefore, this study conducted data mining and analysis of AE signals (especially for suicide/self-injury) associated with D/B using the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods: This study used the disproportionality method to systematically evaluate the associations between D/B and potential AEs and compared these AEs with AEs related to bupropion and esketamine by using data from the FAERS collected between the third quarter of 2022 and the second quarter of 2024. Results: A total of 2451 AE reports identifying D/B as the "primary suspect" were collected. From these reports, 81 preferred terms and 24 system organ classifications were identified, with a predominant focus on psychiatric disorders (22.07%) and nervous system disorders (18.77%). These AEs were mostly found in individuals aged 18–44 years. The median time to onset for D/B-related AEs was determined to be 2 days. Nearly 20 novel AEs identified during the labelling process were detected, such as a sensation of inebriation and panic attacks. Importantly, the risk signals for suicide/self-injury associated with D/B were significantly lower than those associated with bupropion and esketamine. However, these signals cannot be ignored in view of their serious consequences. Conclusion: Psychiatric and nervous system disorders, such as suicidal/self-injurious behaviours, require careful monitoring in clinical applications. It is imperative to conduct traditional pharmacoepidemiological research to evaluate whether D/B is linked to an increased risk of dissociative disorders in the future. Moreover, health care professionals should remain vigilant for AE signals not listed in package inserts. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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