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The Association Between Dextromethorphan/Bupropion with Alcohol and Substance Misuse: Reports to the Food and Drug Administration Adverse Event Reporting System (FAERS)

Published online by Cambridge University Press:  23 October 2024

Angela T.H. Kwan Open the ORCID record for Angela T.H. Kwan [Opens in a new window]  and
Roger S. McIntyre Open the ORCID record for Roger S. McIntyre [Opens in a new window]
Angela T.H. Kwan
Affiliation:
Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada Brain and Cognition Discovery Foundation, Toronto, Ontario, Canada
Roger S. McIntyre*
Affiliation:
Department of Psychiatry, University of Toronto, Toronto, ON, Canada
*
Corresponding author: Roger S. McIntyre; Email: [email protected]
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Abstract

Objective

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.

Methods

We 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.

Results

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 “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.

Conclusion

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.

Keywords

Dextromethorphan/bupropion (DXM/BUP)antidepressantsdepressionabusesubstance abuse disorder (SUD)comorbiditytoxicity
Type
Original Research
Information
CNS Spectrums , Volume 29 , Issue 5 , October 2024 , pp. 407 - 411
Copyright
© The Author(s), 2024. Published by Cambridge University Press

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Footnotes

This article has been updated since it was originally published. A notice detailing this has been published.

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