PMID- 35140642
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220308
IS  - 1664-0640 (Print)
IS  - 1664-0640 (Electronic)
IS  - 1664-0640 (Linking)
VI  - 12
DP  - 2021
TI  - Reported Cases of Serotonin Syndrome in MDMA Users in FAERS Database.
PG  - 824288
LID - 10.3389/fpsyt.2021.824288 [doi]
LID - 824288
AB  - 3,4-Methylenedioxymethamphetamine (MDMA), is investigated as a treatment for 
      post-traumatic stress disorder and other anxiety-related conditions in multiple 
      placebo-controlled and open label studies. MDMA-assisted therapy is projected for 
      approval by the United States Food and Drug Administration (FDA) and other 
      regulatory agencies worldwide within the next few years. MDMA is a monoamine 
      releaser and uptake inhibitor affecting serotonin, potentially increasing the 
      risk of serotonin syndrome (SS). No instances of SS have occurred in clinical 
      trials. The relatively small number of patients in controlled trials warranted a 
      survey of FDA Adverse Event Reporting System data for the occurrence of SS in a 
      larger database. We found 20 SS cases in people exposed to MDMA, all of which had 
      also taken one or more substances with serotonergic properties in addition to 
      MDMA, including amphetamines, stimulants, and opioids. There were no cases of SS 
      associated with MDMA where MDMA was the sole reported compound taken.
CI  - Copyright (c) 2022 Makunts, Jerome, Abagyan and de Boer.
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 - Jerome, Lisa
AU  - Jerome L
AD  - MAPS Public Benefit Corporation, San Jose, CA, 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.
FAU - de Boer, Alberdina
AU  - de Boer A
AD  - MAPS Public Benefit Corporation, San Jose, CA, United States.
LA  - eng
GR  - R35 GM131881/GM/NIGMS NIH HHS/United States
PT  - Journal Article
DEP - 20220124
PL  - Switzerland
TA  - Front Psychiatry
JT  - Frontiers in psychiatry
JID - 101545006
PMC - PMC8820588
OTO - NOTNLM
OT  - FAERS database
OT  - MDMA (3, 4- methylenedioxymethamphetamine)
OT  - case reports [publication type]
OT  - serotonin syndrome
OT  - surveillance system
COIS- The authors 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- 2022/02/11 06:00
MHDA- 2022/02/11 06:01
PMCR- 2022/01/24
CRDT- 2022/02/10 05:35
PHST- 2021/11/29 00:00 [received]
PHST- 2021/12/28 00:00 [accepted]
PHST- 2022/02/10 05:35 [entrez]
PHST- 2022/02/11 06:00 [pubmed]
PHST- 2022/02/11 06:01 [medline]
PHST- 2022/01/24 00:00 [pmc-release]
AID - 10.3389/fpsyt.2021.824288 [doi]
PST - epublish
SO  - Front Psychiatry. 2022 Jan 24;12:824288. doi: 10.3389/fpsyt.2021.824288. 
      eCollection 2021.