Reported Cases of Serotonin Syndrome in MDMA Users in FAERS Database
Tigran Makunts, Lisa Jerome, Ruben Abagyan, Alberdina de Boer
Frontiers in Psychiatry January 24, 2022 DOI: 10.3389/fpsyt.2021.824288 via DOAJ
Summary
AI-generated from the abstractMDMA, also known as ecstasy, is being studied as a treatment for PTSD and anxiety, with approval expected soon. Although MDMA affects serotonin and could theoretically cause serotonin syndrome—a potentially dangerous condition—no cases have occurred in clinical trials. A review of FDA adverse event reports found 20 cases of serotonin syndrome in people who took MDMA, but all had also used other serotonergic drugs such as amphetamines, stimulants, or opioids. No cases were linked to MDMA alone. These findings suggest that serotonin syndrome from MDMA alone is rare or absent in the available data.
Study at a glance
| Characteristics | Retrospective database analysis Placebo-controlled Open-label Peer reviewed |
|---|---|
| Sample size | 20 |
| Population | People with adverse event reports involving MDMA in the FDA Adverse Event Reporting System |
| Keywords | Serotonin syndrome Faers database Surveillance system |
| Citations | 19 |
| Key finding | All 20 cases of serotonin syndrome associated with MDMA involved co-use of other serotonergic substances; no cases occurred with MDMA alone. |
Abstract
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.