Esketamine demonstrates safety in real world

The real-world use of esketamine nasal spray is safe and has a safety profile consistent with that established in clinical studies and current product labeling, reports a US study. No new safety signals have been noted.

Researchers evaluated US safety data from patient monitoring forms submitted to the esketamine Risk Evaluation and Mitigation Strategy (REMS) program and reports submitted to the Janssen US Global Medical Safety (US-GMS) database from 5 March 2019 to 5 January 2024.

The research team then described patient characteristics, use and dosage patterns, adverse events of interest (actively solicited reports of sedation, dissociation, and increased blood pressure), and serious adverse events following esketamine administration. They also evaluated the incidence of suicidality and drug abuse or misuse.

Of the patients, 64.3 percent were aged 26‒55 years, and 61.1 percent were female. Overall, 58,483 patients who had at least one esketamine treatment session completed a total of 1,486,213 outpatient treatment sessions. Sedation was reported in 34.7 percent of sessions, as were dissociation and increased blood pressure in 41.0 percent and 0.9 percent of sessions, respectively.

Serious adverse events occurred in <0.1 percent and 0.18 percent of treatment sessions in REMS and US-GMS, respectively. In addition, the rates of suicide were lower than background rates, and some 210 incidences of all-cause abuse/misuse were reported.