{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,25]],"date-time":"2026-04-25T04:36:45Z","timestamp":1777091805579,"version":"3.51.4"},"reference-count":27,"publisher":"Cambridge University Press (CUP)","issue":"5","license":[{"start":{"date-parts":[[2024,10,23]],"date-time":"2024-10-23T00:00:00Z","timestamp":1729641600000},"content-version":"unspecified","delay-in-days":22,"URL":"https:\/\/www.cambridge.org\/core\/terms"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["CNS Spectr."],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec id=\"S1092852924000415_sec1\"><jats:title>Objective<\/jats:title><jats:p>Dextromethorphan\/bupropion (DXM\/BUP) received Food and Drug Administration (FDA) approval for the treatment of adults with major depressive disorder (MDD) in August 2022. This combination is not known to have abuse liability and is not currently scheduled by the Drug Enforcement Administration (DEA). Notwithstanding, dextromethorphan is a drug of abuse. Herein, we sought to determine whether DXM\/BUP has alcohol and\/or substance misuse liability.<\/jats:p><\/jats:sec><jats:sec id=\"S1092852924000415_sec2\" sec-type=\"methods\"><jats:title>Methods<\/jats:title><jats:p>We evaluated spontaneous reports of terms such as \u201calcohol problem, alcoholism, alcohol abuse, substance dependence, substance use disorder (SUD), substance abuse, drug dependence, drug use disorder and drug abuse\u201d in the FDA Adverse Event Reporting System (FAERS). The FAERS is a spontaneous reporting database of adverse events submitted to the FDA.<\/jats:p><\/jats:sec><jats:sec id=\"S1092852924000415_sec3\" sec-type=\"results\"><jats:title>Results<\/jats:title><jats:p>We performed a comparative assessment of the alcohol and\/or substance misuse liability of DXM\/BUP since its market authorization in August 2022, using acetaminophen as the control. Dextromethorphan served as the upper-bound reference point. Our findings showed that, since August 2022, dextromethorphan had a significant reporting odds ratio (ROR) for \u201cdrug abuse.\u201d In contrast, DXM\/BUP did not have a significant ROR for any of the categories of alcohol and\/or substance misuse evaluated. Limitations of our findings derive largely from the limitations of the FAERS and its data capture method.<\/jats:p><\/jats:sec><jats:sec id=\"S1092852924000415_sec4\" sec-type=\"conclusions\"><jats:title>Conclusion<\/jats:title><jats:p>The absence of alcohol or substance misuse reported to the FAERS with DXM\/BUP accords with the lack of evidence of abuse liability prior to FDA approval and its non-scheduling by the DEA.<\/jats:p><\/jats:sec>","DOI":"10.1017\/s1092852924000415","type":"journal-article","created":{"date-parts":[[2024,10,23]],"date-time":"2024-10-23T03:30:11Z","timestamp":1729654211000},"page":"407-411","source":"Crossref","is-referenced-by-count":4,"title":["The Association Between Dextromethorphan\/Bupropion with Alcohol and Substance Misuse: Reports to the Food and Drug Administration Adverse Event Reporting System (FAERS)"],"prefix":"10.1017","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4013-1112","authenticated-orcid":false,"given":"Angela T.H.","family":"Kwan","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4733-2523","authenticated-orcid":false,"given":"Roger S.","family":"McIntyre","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"56","published-online":{"date-parts":[[2024,10,23]]},"reference":[{"key":"S1092852924000415_r11","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0000000000001387"},{"key":"S1092852924000415_r16","doi-asserted-by":"publisher","DOI":"10.1007\/s13181-019-00706-1"},{"key":"S1092852924000415_r15","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajem.2019.10.001"},{"key":"S1092852924000415_r1","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-023-01032-5"},{"key":"S1092852924000415_r8","doi-asserted-by":"publisher","DOI":"10.1254\/jphs.11008FP"},{"key":"S1092852924000415_r9","doi-asserted-by":"publisher","DOI":"10.1017\/S109285291900155X"},{"key":"S1092852924000415_r4","doi-asserted-by":"publisher","DOI":"10.1002\/wps.21120"},{"key":"S1092852924000415_r5","doi-asserted-by":"publisher","DOI":"10.1080\/03602532.2020.1758712"},{"key":"S1092852924000415_r12","doi-asserted-by":"publisher","DOI":"10.1016\/j.bcp.2016.11.007"},{"key":"S1092852924000415_r17","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1923"},{"key":"S1092852924000415_r18","doi-asserted-by":"publisher","DOI":"10.1016\/j.pbb.2020.172919"},{"key":"S1092852924000415_r19","unstructured":"19. Center for Drug Evaluation, Research. Drug Approvals and Databases. U.S. Food and Drug Administration. Published December 20, 2023. Accessed January 14, 2024. https:\/\/www.fda.gov\/drugs\/development-approval-process-drugs\/drug-approvals-and-databases"},{"key":"S1092852924000415_r20","article-title":"The association between glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and suicidality: reports to the Food and Drug Administration Adverse Event Reporting System (FAERS)","author":"McIntyre","journal-title":"Expert Opin Drug Saf"},{"key":"S1092852924000415_r22","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15581"},{"key":"S1092852924000415_r23","doi-asserted-by":"publisher","DOI":"10.1111\/add.15735"},{"key":"S1092852924000415_r24","doi-asserted-by":"publisher","DOI":"10.1177\/00048674211054740"},{"key":"S1092852924000415_r14","doi-asserted-by":"publisher","DOI":"10.1080\/15563650.2017.1416124"},{"key":"S1092852924000415_r26","unstructured":"26. Center for Drug Evaluation, Research. FDA Adverse Event Reporting System (FAERS) Public Dashboard. U.S. Food and Drug Administration. Published December 7, 2023. Accessed January 14, 2024. https:\/\/www.fda.gov\/drugs\/questions-and-answers-fdas-adverse-event-reporting-system-faers\/fda-adverse-event-reporting-system-faers-public-dashboard"},{"key":"S1092852924000415_r13","doi-asserted-by":"publisher","DOI":"10.5812\/aapm.20990"},{"key":"S1092852924000415_r25","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2020.12.043"},{"key":"S1092852924000415_r7","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0089985"},{"key":"S1092852924000415_r6","doi-asserted-by":"publisher","DOI":"10.1021\/acschemneuro.3c00088"},{"key":"S1092852924000415_r3","unstructured":"3. ClinicalTrials.Gov. Accessed January 14, 2024. https:\/\/clinicaltrials.gov\/search?intr=Bupropion%20dextromethorphan"},{"key":"S1092852924000415_r21","volume-title":"Odds Ratio","author":"Tenny","year":"2023"},{"key":"S1092852924000415_r27","doi-asserted-by":"publisher","DOI":"10.1186\/s12982-015-0037-4"},{"key":"S1092852924000415_r10","volume-title":"Bupropion","author":"Huecker","year":"2023"},{"key":"S1092852924000415_r2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.21m14345"}],"container-title":["CNS Spectrums"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1092852924000415","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,10]],"date-time":"2025-01-10T04:24:22Z","timestamp":1736483062000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1092852924000415\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10]]},"references-count":27,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,10]]}},"alternative-id":["S1092852924000415"],"URL":"https:\/\/doi.org\/10.1017\/s1092852924000415","relation":{},"ISSN":["1092-8529","2165-6509"],"issn-type":[{"value":"1092-8529","type":"print"},{"value":"2165-6509","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10]]}}}