HQ Team
October 10, 2023: Compounded ketamine products used to treat psychiatric disorders, are not safe, may put patients at severe risk of adverse events, and are not approved by the FDA, the regulator warned.
The Food and Drug Administration has not approved ketamine or compounded ketamine products for the treatment of any psychiatric disorder, according to a statement from the US drug regulator.
“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,”
FDA stated it was aware that compounded ketamine products have been marketed for a wide variety of psychiatric disorders — depression, anxiety, post-traumatic stress disorder, and obsessive-compulsive disorder.
“However, FDA has not determined that ketamine is safe and effective for such uses.”
Safety concerns
Safety concerns associated with the use of ketamine products include abuse and misuse, psychiatric events, increases in blood pressure, slowed breathing, and lower urinary tract and bladder symptoms.
Ketamine hydrochloride is a Schedule III-controlled substance that is FDA-approved as an intravenous or intramuscular injection solution for induction and maintenance of general anaesthesia.
The regulator had also approved Spravato, a nasal spray, for treatment-resistant depression in adults, and for depressive symptoms in adults with acute suicidal ideation or behaviour.
Janssen Pharmaceuticals’ Spravato got the FDA approval in 2019 for treatment-resistant depression.
The February 2022 compounding risk alert provided information about Spravato, which is subject to a Risk Evaluation and Mitigation Strategy (REMS) as part of its FDA approval.
A REMS is a drug safety program that the FDA requires for certain approved medications with serious safety concerns to ensure the benefits of the medication outweigh its risks. Spravato (esketamine) cannot be dispensed for use outside the certified healthcare setting.
Pop-up clinics
On February 16, 2022, the FDA published a compounding risk alert describing the potential risks associated with at-home use of compounded ketamine nasal spray.
Pop-up ketamine clinics have proliferated in the US, as well as prescribers offering it through telehealth, according to the American Drug Association.
Most of these clinics offered I.V. ketamine infusions off-label to patients for an out-of-pocket cost.
I.V. ketamine is not FDA-approved like eskatamine, one of the two molecules of ketamine, and does not fall under a REMS program.
The FDA stated that it was aware of increasing public interest in the use of “sublingual and oral dosage forms” of compounded ketamine.
“However, the lack of monitoring for adverse events, such as sedation and dissociation, by an onsite health care provider may put patients at risk.”
