Recently, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals to the potential risks of compounded ketamine nasal spray.
The compounded ketamine is being used to treat psychiatric disorders. Unlike the Schedule III nasal spray treatment, Spravato (esketamine), compounded ketamine nasal spray is not FDA-approved and has no FDA-approved dosing regimen.
FDA is issuing this alert due to the increased awareness of adverse events reported, the seriousness of these adverse events, and the likelihood that adverse events related to compounded drug products are under-reported.
The FDA has expressed concern that the off-label use of ketamine in any formulation may increase a patient's risk of drug misuse or abuse. Read the FDA's announcement regarding compounded ketamine nasal spray.