Safety labelling for esketamine (Spravato) updated in the US to include risk of respiratory depression and arrest

There were 40 cases of respiratory depression and two cases of respiratory arrest reported with its use from March 2019-Feb 2023, out of 868,000 treatment sessions. The label update in the US will include monitoring with pulse oximetry (specific details are pending with the FDA).

SPS commentary:

The current UK SPC notes respiratory depression may occur at high doses following rapid IV injection of esketamine when used for anaesthesia, but that no cases were observed in clinical trials with esketamine nasal spray.

Formulary Watch