Post by Admin on Jan 28, 2021 15:36:10 GMT
A recent article published in Psychotherapy and Psychosomatics examines the health risks of esketamine nasal spray for treatment-resistant depression. Through an analysis of adverse events reported to the FDA, the authors found several adverse events related to the use of esketamine nasal spray, such as dissociation, sedation, feeling drunk, completed suicide, and especially suicidal and self-injurious ideation.
“Esketamine marketing authorization triggered a vivid debate and many concerns, mainly because of the lack of convincing evidence on its efficacy and safety, including the risk of misuse and suicide. Currently, evidence on safety is almost entirely based on the development programs and approval trials,” the authors write.
“A pooled analysis on the safety profile of esketamine, based on data from the approval trials, found that it was significantly less acceptable than placebo and that the risk of dissociation was 7 times higher than placebo, with approximately one-fourth of patients treated with esketamine reporting severe dissociation during treatment.”
New Research Questions Safety of Esketamine for Depression
An analysis of FDA adverse event reports related to esketamine shows the potential for negative effects such as suicidal and self-injurious ideation.
www.madinamerica.com/2021/01/new-research-questions-safety-esketamine-depression/
Psychotherapy and Psychosomatics
Standard Research Article
Post-Marketing Safety Concerns with Esketamine: A Disproportionality Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System
www.karger.com/Article/Abstract/510703
“Esketamine marketing authorization triggered a vivid debate and many concerns, mainly because of the lack of convincing evidence on its efficacy and safety, including the risk of misuse and suicide. Currently, evidence on safety is almost entirely based on the development programs and approval trials,” the authors write.
“A pooled analysis on the safety profile of esketamine, based on data from the approval trials, found that it was significantly less acceptable than placebo and that the risk of dissociation was 7 times higher than placebo, with approximately one-fourth of patients treated with esketamine reporting severe dissociation during treatment.”
New Research Questions Safety of Esketamine for Depression
An analysis of FDA adverse event reports related to esketamine shows the potential for negative effects such as suicidal and self-injurious ideation.
www.madinamerica.com/2021/01/new-research-questions-safety-esketamine-depression/
Psychotherapy and Psychosomatics
Standard Research Article
Post-Marketing Safety Concerns with Esketamine: A Disproportionality Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System
www.karger.com/Article/Abstract/510703