PMID- 33727616
OWN - NLM
STAT- MEDLINE
DCOM- 20211215
LR  - 20211215
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 11
IP  - 1
DP  - 2021 Mar 16
TI  - Concomitant drugs associated with increased mortality for MDMA users reported in 
      a drug safety surveillance database.
PG  - 5997
LID - 10.1038/s41598-021-85389-x [doi]
LID - 5997
AB  - 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.
FAU - Cohen, Isaac V
AU  - Cohen IV
AD  - Clinical PharMacology and Therapeutics Postdoctoral Training Program, University 
      of California San Francisco, San Francisco, CA, USA.
FAU - Makunts, Tigran
AU  - Makunts T
AD  - Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California 
      San Diego, La Jolla, CA, USA.
AD  - Oak Ridge Institute of Science and Education, Clinical Pharmacology and Machine 
      Learning Fellowship At the Center for Drug Evaluation and Research, United States 
      Food and Drug Administration, Silver Spring, MD, USA.
FAU - Abagyan, Ruben
AU  - Abagyan R
AD  - Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California 
      San Diego, La Jolla, CA, USA. rabagyan@health.ucsd.edu.
FAU - Thomas, Kelan
AU  - Thomas K
AD  - College of Pharmacy, Touro University California, Vallejo, CA, USA.
LA  - eng
GR  - R35 GM131881/GM/NIGMS NIH HHS/United States
PT  - Journal Article
DEP - 20210316
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 0 (Antidepressive Agents)
RN  - 0 (Serotonin Agents)
RN  - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Antidepressive Agents/adverse effects/therapeutic use
MH  - Cause of Death
MH  - Databases, Factual
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/mortality
MH  - Health Care Surveys
MH  - Humans
MH  - Mortality
MH  - Multivariate Analysis
MH  - N-Methyl-3,4-methylenedioxyamphetamine/*adverse effects/therapeutic use
MH  - Odds Ratio
MH  - Public Health Surveillance
MH  - Serotonin Agents/adverse effects/therapeutic use
MH  - Stress Disorders, Post-Traumatic/complications/epidemiology/mortality/therapy
MH  - United States/epidemiology
MH  - United States Food and Drug Administration
PMC - PMC7966744
COIS- I.V.C. is an unpaid trainee and K.T. is an unpaid volunteer at MAPS Public 
      Benefit Corporation who have not received any financial compensation related to 
      this paper or other projects. All other authors declare no conflict of financial 
      or non-financial interests.
EDAT- 2021/03/18 06:00
MHDA- 2021/12/16 06:00
PMCR- 2021/03/16
CRDT- 2021/03/17 06:29
PHST- 2020/08/03 00:00 [received]
PHST- 2021/02/25 00:00 [accepted]
PHST- 2021/03/17 06:29 [entrez]
PHST- 2021/03/18 06:00 [pubmed]
PHST- 2021/12/16 06:00 [medline]
PHST- 2021/03/16 00:00 [pmc-release]
AID - 10.1038/s41598-021-85389-x [pii]
AID - 85389 [pii]
AID - 10.1038/s41598-021-85389-x [doi]
PST - epublish
SO  - Sci Rep. 2021 Mar 16;11(1):5997. doi: 10.1038/s41598-021-85389-x.