The Association Between Dextromethorphan/Bupropion with Alcohol and Substance Misuse: Reports to the Food and Drug Administration Adverse Event Reporting System (FAERS)
Angela T.H. Kwan, Roger S. McIntyre
CNS Spectrums October 1, 2024 DOI: 10.1017/s1092852924000415 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Observational pharmacovigilance study using spontaneous adverse event reports Peer reviewed |
|---|---|
| Population | Spontaneous adverse event reports submitted to the FDA Adverse Event Reporting System |
| Interventions | Dextromethorphan/bupropion Dextromethorphan Acetaminophen |
| Key findings | In FDA Adverse Event Reporting System data since August 2022, dextromethorphan had a significant reporting odds ratio for drug abuse, whereas dextromethorphan/bupropion showed no significant reporting odds ratio for any alcohol or substance misuse category evaluated. The authors state this absence of misuse reports accords with pre-approval evidence of no abuse liability and the drug's non-scheduling by the DEA. |
Abstract
AbstractObjectiveDextromethorphan/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.MethodsWe evaluated spontaneous reports of terms such as “alcohol problem, alcoholism, alcohol abuse, substance dependence, substance use disorder (SUD), substance abuse, drug dependence, drug use disorder and drug abuse” in the FDA Adverse Event Reporting System (FAERS). The FAERS is a spontaneous reporting database of adverse events submitted to the FDA.ResultsWe 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 “drug abuse.” 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.ConclusionThe 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.