scholarly journals Concomitant drugs associated with increased mortality for MDMA users reported in a drug safety surveillance database

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Isaac V. Cohen ◽  
Tigran Makunts ◽  
Ruben Abagyan ◽  
Kelan Thomas

Abstract3,4-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.

Drug Safety ◽  
2017 ◽  
Vol 41 (1) ◽  
pp. 125-137 ◽  
Author(s):  
Yu Yang ◽  
Xiaofeng Zhou ◽  
Shuangqing Gao ◽  
Hongbo Lin ◽  
Yanming Xie ◽  
...  

Author(s):  
Homero Contreras-Salinas ◽  
Leopoldo Martín Baiza-Durán ◽  
Mariana Barajas-Hernández ◽  
Alan Omar Vázquez-Álvarez ◽  
Lourdes Yolotzin Rodríguez-Herrera

(1) Background: drugs provide a significant benefit; however, their use implies an intrinsic potential danger, with the possibility to cause unwanted effects. These effects are known as adverse drug reactions (ADRs). Post-marketing drug safety surveillance detects unknown risks that have not been identified in clinical trials and it is necessary to monitor marketed medications under real-life practice. Due to the scarce information about fixed combination of ciprofloxacin 0.3% / dexamethasone 0.1% (SDO), we performed a drug safety surveillance study. (2) Methods: A prospective non-controlled drug safety surveillance study was conducted in Peruvian population. A total of 236 patients prescribed SDO were included derivates from 12 sites. Patients' standardized information was collected through two phone calls, including demographics, medical history, prescribing patterns of SDO, concomitant medication, and ADRs in detail. The ADRs were classified by causality and severity, followed by outcome measures to identify new risk. (3) Results: 236 patients prescribed with SDO participated in the study and 220 were included. A total of 82 ADRs/220 patients were reported after the use of SDO, presenting a ratio 0.37 ADR/patient. The most frequent ADR with SDO administration was eye irritation (30%). The totality of the ADR was classified as non-serious, and the 97.5% (n=80) was classified as mild and 2.5% as moderate (n=2). No cases under the severe category were identified. (4) Conclusion: No new risks were found in the population where this study was conducted.


2019 ◽  
Vol 7 ◽  
pp. S46 ◽  
Author(s):  
Yohanna Kambai Avong ◽  
Bolajoko Jatau ◽  
Gbenga Ayodele Kayode ◽  
Blessing Ukpabi ◽  
Eunice Bosede Avong ◽  
...  

2006 ◽  
Vol 15 (9) ◽  
pp. 675-682 ◽  
Author(s):  
Willemijn M. Meijer ◽  
Martina C. Cornel ◽  
Helen Dolk ◽  
Hermien E. K. de Walle ◽  
Nicola C. Armstrong ◽  
...  

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