Concomitant medications associated with ischemic, hypertensive, and arrhythmic events in MDMA users in FDA adverse event reporting system
Tigran Makunts, Diane Dahill, Lisa Jerome, Alberdina de Boer, Ruben Abagyan
Frontiers in Psychiatry May 18, 2023 DOI: 10.3389/fpsyt.2023.1149766 via OpenAlex
Summary
AI-generated from the abstractMDMA is being tested as a treatment aid for PTSD and anxiety disorders, and regulatory approval is expected soon. Its main effects involve increasing serotonin, norepinephrine, and dopamine activity, which can raise heart rate and blood pressure. Clinical trials have limited data on cardiac side effects due to small participant numbers and restricted use of other drugs. An analysis of FDA adverse event reports found 17 cardiovascular cases where people took MDMA plus other substances. All accompanying drugs—opioids, stimulants, anticholinergics, and amphetamines—are already linked to heart problems. In none of these reports was MDMA considered the primary cause.
Study at a glance
| Characteristics | Retrospective analysis of adverse event reports Peer reviewed |
|---|---|
| Sample size | 17 |
| Population | Individuals who experienced cardiovascular adverse events and had taken MDMA plus other substances, as reported to the FDA Adverse Event Reporting System |
| Topics | MDMA |
| Keywords | Concomitant Adverse effect Internal medicine Anesthesia |
| Citations | 6 |
| Key finding | All 17 cardiovascular adverse events occurred in individuals taking MDMA with other substances already associated with cardiac risks, and MDMA was never the primary suspect. |
Abstract
3,4-Methylenedioxymethamphetamine (MDMA) is currently being investigated as an adjunctive treatment to therapy for posttraumatic stress and other anxiety related disorders in clinical trials. Within the next few years MDMA-assisted therapy is projected for approval by regulatory authorities. MDMA's primary mechanism of action includes modulation of monoamine signaling by increasing release and inhibiting reuptake of serotonin, norepinephrine, and, to a lesser extent, dopamine. This pharmacology affects sympathomimetic physiology. In controlled trials, special attention has been given to cardiovascular adverse events (AEs), because transient increases in heart rate and blood pressure have been observed during the MDMA-assisted therapy sessions. Finding and quantifying the potential drivers of cardiac AEs in clinical trials is difficult since only a relatively small number of participants have been included in these studies, and a limited set of allowed concomitant drugs has been studied. In this study a more diverse set of reports from the FDA Adverse Event Reporting System was surveyed. We found 17 cases of cardiovascular AEs, in which the individuals had taken one or more substances in addition to MDMA. Interestingly, all of those concomitant medications and illicit substances, including opioids, stimulants, anticholinergics, and amphetamines, had been previously associated with cardiovascular AEs. Furthermore, in none of the reports MDMA was marked as the primary suspect.