FDA will issue a formal safety communication on ketamine/esketamine and suicidality before October 2026, including updated REMS requirements for Spravato.

The FDA will issue a formal safety communication warning doctors and hospitals about suicidality (suicide risk) linked to ketamine and its cousin esketamine (sold as Spravato) before October 2026. The agency will also tighten how these drugs can be prescribed (called REMS — Risk Evaluation and Mitigation Strategy). This matters because hospitals are increasingly using ketamine in emergency departments, and the FDA has spotted a signal that suicides are going up among people using it.

Post-market suicidality signals from ED utilization data create a clear regulatory obligation. REMS modification is the lowest-friction, most precedented agency response to live safety signals of this type. Falsifiable by presence or absence of a specific FDA safety communication with REMS language by the resolve date.