Serious, ‘Unexpected’ Adverse Events From Nasal Esketamine

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From Medscape: “Patients who receive esketamine for ‘treatment-resistant depression’ are at increased risk for serious and unexpected adverse events (AEs), new research suggests.

. . . The researchers identified 2274 esketamine-related AEs among 962 patients (mean, 2.4 events per person); 389 patients had a serious AE, and there were 22 deaths.

Expected, Unexpected Findings

Serious treatment-related AEs were significantly more common among women; patients given higher doses of esketamine; those who were also taking mood stabilizers, antipsychotics, benzodiazepines, or somatic medications; and patients with comorbidities (< .001 for all).

Disproportionality analysis showed that several AEs were significantly associated with use of esketamine compared with other drugs. These included dissociation (reporting odds ratio [ROR], 1612.64), sedation (ROR, 238.46), feeling drunk (ROR, 96.17), suicidal ideation (ROR, 24.03), and completed suicide (ROR, 5.75).

[Lead author Chaira] Gastaldon emphasized that these AEs were expected because they were ‘also reported by the approval trials.’

However, she noted that, compared with those taking other antidepressants, patients taking esketamine also had higher rates of disorder-related AEs, such as self-injurious ideation (ROR, 42.80), depression (ROR, 9.17), and crying (ROR, 9.01).

There were also a series of unexpected AEs that were significantly increased in the esketamine group. These included autoscopy (ROR, 166.44), derealization (ROR, 56.98), euphoric mood (ROR, 46.03), logorrhea (ROR, 44.34), panic attack (ROR, 13.57), and paranoia (ROR, 13.48).”

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3 COMMENTS

  1. How does anyone think this is a good idea?! The public is truly desperate.

    Yeah, big surprise that taking ketamine will cause autoscopy (out of body experience s) and derealization … Or absolutely NO SURPRISE AT ALL. How stupid are these researchers?! Or, how greedy their employers?

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