A real-world pharmacovigilance study of esketamine nasal spray.

Analysis of post-marketing safety data for esketamine nasal spray, using four statistical methods on 5,132 adverse event reports from the FDA Adverse Event Reporting System (Q1 2019 to Q2 2023), identified dissociation, sedation, and hypertension as the most frequently observed adverse drug events. New rare signals were detected, including interstitial cystitis, substance abuse, and drug diversion. These findings may help healthcare professionals assess patient symptoms and identify risks during clinical use.

Study at a glance

Abstract

Mining and updating the post-marketing safety signals of esketamine nasal spray for better identification of adverse drug event (ADE) signals and medication monitoring during clinical use to ensure patient medication safety. Downloading data from the US Food and Drug Administration Adverse Event Reporting System from Q1 2019 to Q2 2023, the reporting odds ratio, proportional reporting ratio, Multi-item Gamma Poisson Shrinker, and Bayesian Confidence Propagation Neural Network methods of the disproportionality method were used to mine and analyze ADEs, and finally to screen for signals of ADEs with esketamine nasal spray as the primary suspected drug. The Preferred Terminology of the Medical Dictionary of Regulatory Activities (version 26.0) was used to standardize the description of ADEs and to attribute ADEs to the System Organ Classification. A total of 5132 ADEs reports of esketamine nasal spray as the primary suspected drug were obtained from the Food and Drug Administration Adverse Event Reporting System. The most frequently observed ADEs are dissociation, sedation, and hypertension, while some new rare signals have been detected, such as interstitial cystitis, substance abuse, and drug diversion. The present study identified significant new ADEs signals for esketamine nasal spray, which may provide a source for healthcare professionals to assess patients' symptoms and risk identification.