FDA warns of dangers in treating psychiatric disorders with ketamine

Tara Suter
Thu, October 12, 2023 

The Food and Drug Administration (FDA) is warning consumers about the dangers of using ketamine to treat psychiatric disorders.

“Ketamine is not FDA approved for the treatment of any psychiatric disorder,” the FDA said on its website Tuesday. “FDA is aware that compounded ketamine products have been marketed for a wide variety of psychiatric disorders … however, FDA has not determined that ketamine is safe and effective for such uses.”

Ketamine is the short name for ketamine hydrochloride, which is a Schedule 3 controlled substance, according to the FDA. The treatment is FDA-approved as an “intravenous or intramuscular injection solution for induction and maintenance of general anesthesia.”

“FDA understands that the ability to obtain such products through telemedicine platforms and compounders for at-home use may be attractive to some patients,” the FDA said on its website. “The lack of monitoring for adverse events, such as sedation and dissociation, by an onsite health care provider may put patients at risk.”

The FDA said it has identified safety concerns associated with compounded ketamine products, and the agency hasn’t outlined “safe or effective dosing of ketamine for any psychiatric indication” precisely because it hasn’t approved the drug for such uses.

“These factors may place the patient at risk for serious adverse events, misuse, and abuse,” the agency warned.

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