PMID- 37275981
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230610
IS  - 1664-0640 (Print)
IS  - 1664-0640 (Electronic)
IS  - 1664-0640 (Linking)
VI  - 14
DP  - 2023
TI  - Concomitant medications associated with ischemic, hypertensive, and arrhythmic 
      events in MDMA users in FDA adverse event reporting system.
PG  - 1149766
LID - 10.3389/fpsyt.2023.1149766 [doi]
LID - 1149766
AB  - 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.
CI  - Copyright (c) 2023 Makunts, Dahill, Jerome, de Boer and Abagyan.
FAU - Makunts, Tigran
AU  - Makunts T
AD  - MAPS Public Benefit Corporation, San Jose, CA, United States.
AD  - Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, 
      San Diego, San Diego, CA, United States.
FAU - Dahill, Diane
AU  - Dahill D
AD  - MAPS Public Benefit Corporation, San Jose, CA, United States.
FAU - Jerome, Lisa
AU  - Jerome L
AD  - MAPS Public Benefit Corporation, San Jose, CA, United States.
FAU - de Boer, Alberdina
AU  - de Boer A
AD  - Tulip Medical Consulting LLC, Port Townsend, WA, United States.
FAU - Abagyan, Ruben
AU  - Abagyan R
AD  - Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, 
      San Diego, San Diego, CA, United States.
LA  - eng
GR  - R35 GM131881/GM/NIGMS NIH HHS/United States
PT  - Journal Article
DEP - 20230518
PL  - Switzerland
TA  - Front Psychiatry
JT  - Frontiers in psychiatry
JID - 101545006
PMC - PMC10233020
OTO - NOTNLM
OT  - 3,4-methylenedioxymethamphetamine
OT  - MDMA
OT  - adverse events
OT  - arrhythmia
OT  - cardiovascular
OT  - hypertension
OT  - schaemia
COIS- TM, DD, and LJ were employed by MAPS Public Benefit Corporation. AB was employed 
      by Tulip Medical Consulting LLC. The remaining author declare that the research 
      was conducted in the absence of any commercial or financial relationships that 
      could be construed as a potential conflict of interest.
EDAT- 2023/06/05 19:10
MHDA- 2023/06/05 19:11
PMCR- 2023/05/18
CRDT- 2023/06/05 12:25
PHST- 2023/01/23 00:00 [received]
PHST- 2023/04/18 00:00 [accepted]
PHST- 2023/06/05 19:11 [medline]
PHST- 2023/06/05 19:10 [pubmed]
PHST- 2023/06/05 12:25 [entrez]
PHST- 2023/05/18 00:00 [pmc-release]
AID - 10.3389/fpsyt.2023.1149766 [doi]
PST - epublish
SO  - Front Psychiatry. 2023 May 18;14:1149766. doi: 10.3389/fpsyt.2023.1149766. 
      eCollection 2023.