Psych Congress NetworkFDA Issues Warning Highlighting Risks of Ketamine for Psychiatric Disorder Treatment

FDA Cautions on Risks of Compounded Ketamine for Psychiatric Disorders: A Tightrope Walk for Clinicians and Patients

The US Food and Drug Administration (FDA) has recently issued a warning about the use of compounded ketamine products for the treatment of psychiatric disorders. This warning highlights the delicate balance that clinicians and patients must maintain when considering treatments that lack FDA approval.

Key Points

• The FDA has not approved ketamine for the treatment of any psychiatric disorder.
• Compounded ketamine products, including oral formulations, are being marketed for a variety of psychiatric disorders such as depression, anxiety, PTSD, and obsessive-compulsive disorder.
• These compounded drugs have not undergone evaluation for safety, efficacy, or quality before reaching the market.
• The use of compounded ketamine products without proper monitoring by a healthcare provider can lead to serious adverse events, including sedation, dissociation, and changes in vital signs.
• Ketamine products are associated with other safety concerns, including abuse and misuse, psychiatric events, elevated blood pressure, respiratory depression, and lower urinary tract and bladder symptoms.

While generally safe, ketamine has powerful acute physiological and psychological effects that can pose risks when taken in a non-supervised setting. But having said this, I don’t think we have an adequate understanding of the relevant risks and benefits to come down definitively on the pro- or con side of the use of compounded ketamine.
— Charles Raison, MD, Psych Congress Network’s Depression Section Editor

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