The United States Food and Drug Administration (FDA) has issued a warning to patients and healthcare providers about the potential risks associated with ketamine products amid rising interest in using these products for the treatment of psychiatric disorders.
In a notice dated October 10, the FDA reiterated that ketamine – a Schedule II controlled substance approved for use as an intravenous or intramuscular injection for induction and maintenance of general anesthesia – is not approved for the treatment of psychiatric disorders despite it being marketed as such.
“Although compounded drugs can serve an important medical need for certain patients when an FDA-approved drug is not medically appropriate, they also present a risk to patients and should only be used under the care of a healthcare provider,” the FDA cautioned.
“Despite increased interest in the use of compounded ketamine, we are not aware of evidence to suggest that it is safer, is more effective, or works faster than medications that are FDA-approved for the treatment of certain psychiatric disorders.”
The agency noted that known safety concerns associated with the use of ketamine products included abuse and misuse, psychiatric events, increases in blood pressure, respiratory depression (slowed breathing), and lower urinary tract and bladder symptoms.
It highlighted an adverse event report it received in April 2023 of a patient who experienced respiratory depression after taking compounded oral ketamine outside of a healthcare setting for the treatment of post-traumatic stress disorder.
The patient’s ketamine blood level appeared to be twice the blood level typically obtained for anesthesia, the FDA said.
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