FDA Warns Against Unsupervised Use of Ketamine for Psychiatric Disorders

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has raised concerns over the unsupervised and unauthorized use of compounded ketamine and ketamine-based drugs for treating psychiatric conditions. In a recent alert, the FDA pointed to the dangers posed by the unregulated use of such drugs, especially in the wake of the substance’s growing reputation as a sought-after alternative treatment for mental health issues.

The FDA’s warning was prompted by a specific case in April, where a patient with PTSD consumed oral compounded ketamine without professional oversight. This resulted in a dangerous slowdown in the patient’s breathing, known as respiratory depression, and an unusually elevated level of ketamine in their bloodstream – approximately double the amount typically administered for anesthetic purposes.

Although the FDA’s document does not provide extensive data on the negative outcomes linked to ketamine use, it underscores the distinction between its administration under clinical supervision and the unsupervised, prescribed use promoted by certain telemedicine platforms. These platforms often omit crucial information about the potential risks associated with the drug.

Notably, the only FDA-approved psychiatric use of a ketamine derivative is the nasal spray esketamine, designed to treat Treatment-Resistant Depression. All other psychiatric applications of ketamine remain unauthorized at the federal level. This regulatory gap has paved the way for its frequent misuse, leading to health complications.

In a related announcement, the Drug Enforcement Administration (DEA) declared an extension to the temporary rules, initiated during the pandemic, which allow telehealth prescriptions of controlled medications. This deviation from the standard Ryan Haight Act conditions will now be in place until December 31, 2024. The decision came after the DEA, alongside the Department of Health and Human Services (HHS), held public hearings on the matter, ensuring that the revised regulations would cater to all telehealth interactions, regardless of their start date.