Concomitant drugs associated with increased mortality for MDMA users reported in a drug safety surveillance database
Isaac Cohen, Tigran Makunts, Ruben Abagyan, Kelan Thomas
Scientific Reports March 16, 2021 DOI: 10.1038/s41598-021-85389-x (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Retrospective pharmacovigilance study Peer reviewed |
|---|---|
| Population | MDMA users in FDA drug safety surveillance database |
| Intervention | MDMA |
| Topics | MDMA |
| Keywords | Drug Olanzapine Pharmacology Bupropion Sertraline Venlafaxine Serotonin syndrome |
| Citations | 30 |
| Key points | Several drug classes and specific medications, including bupropion, sertraline, venlafaxine, citalopram, and olanzapine, were associated with increased odds of death among MDMA users. |
Abstract
Abstract 3,4-Methylenedioxymethamphetamine (MDMA) is currently being evaluated by the Food and Drug Administration (FDA) for the treatment of post-traumatic stress disorder (PTSD). If MDMA is FDA-approved it will be important to understand what medications may pose a risk of drug–drug interactions. The goal of this study was to evaluate the risks due to MDMA ingestion alone or in combination with other common medications and drugs of abuse using the FDA drug safety surveillance data. To date, nearly one thousand reports of MDMA use have been reported to the FDA. The majority of these reports include covariates such as co-ingested substances and demographic parameters. Univariate and multivariate logistic regression was employed to uncover the contributing factors to the reported risk of death among MDMA users. Several drug classes (MDMA metabolites or analogs, anesthetics, muscle relaxants, amphetamines and stimulants, benzodiazepines, ethanol, opioids), four antidepressants (bupropion, sertraline, venlafaxine and citalopram) and olanzapine demonstrated increased odds ratios for the reported risk of death. Future drug–drug interaction clinical trials should evaluate if any of the other drug–drug interactions described in our results actually pose a risk of morbidity or mortality in controlled medical settings.
Comparable studies
Other observational and cohort studies on MDMA, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Subjective Reports of the Effects of MDMA in a Clinical Setting Individuals who took MDMA in a clinical setting | 1986 | Observational study | |
| Memory impairment in abstinent MDMA ("Ecstasy") users Abstinent MDMA users | 1998 | Observational cohort | |
| Impaired cognitive performance in drug free users of recreational ecstasy (MDMA) Otherwise healthy young people | 2000 | Observational | |
| The Psychological and Physiological Effects of MDMA on Normal Volunteers Older, more educated, drug-experienced individuals | 1986 | Observational cohort | |
| Cognitive performance in recreational users of MDMA or 'ecstasy': evidence for memory deficits Young people who were regular or novice MDMA users, or non-users | 1998 | Observational cohort | n = 30 |
Citations in the library
Cited by 17
- Drug-drug interactions between psychiatric medications and MDMA or psilocybin: a systematic review Psychopharmacology March 7, 2022
- Reported Cases of Serotonin Syndrome in MDMA Users in FAERS Database Frontiers in Psychiatry January 24, 2022
- First drug-checking study at an electronic festival and fentanyl detection in the central region of Mexico Harm Reduction Journal December 10, 2023
- The entactogen 3,4-methylenedioxymethamphetamine (MDMA; ecstasy) as a treatment aid in psychotherapy and its safety concerns. Archives of Toxicology August 1, 2024
- History, pharmacology and therapeutic mechanisms of 3,4‐methylenedioxymethamphetamine (MDMA) British Journal of Pharmacology October 21, 2025
and 12 more in the library
Cites 9
- The serotonin uptake inhibitor citalopram reduces acute cardiovascular and vegetative effects of 3, 4-methylenedioxymethamphetamine (‘Ecstasy’) in healthy volunteers Journal of Psychopharmacology May 1, 2000
- Safety pharmacology of acute MDMA administration in healthy subjects Journal of Psychopharmacology February 21, 2017
- Pharmacokinetic and pharmacodynamic effects of methylphenidate and MDMA administered alone or in combination The International Journal of Neuropsychopharmacology October 8, 2013
- Who is ‘Molly’? MDMA adulterants by product name and the impact of harm-reduction services at raves Journal of Psychopharmacology July 10, 2017
- CYP2D6 function moderates the pharmacokinetics and pharmacodynamics of 3,4-methylene-dioxymethamphetamine in a controlled study in healthy individuals Pharmacogenetics and Genomics June 2, 2016
and 4 more in the library