FDA Warns on Compounded Ketamine for Psych Disorders

The FDA issued a warning about the use of compounded ketamine products, including oral formulations, for treating psychiatric disorders, due to a recent increased interest.

The warning emphasized that ketamine has not been FDA approved for the treatment of any psychiatric disorder, despite compounded ketamine products being marketed as a treatment option for depression, anxiety, post-traumatic stress disorder (PTSD), and obsessive-compulsive disorder.

The agency noted that it has not determined that ketamine is safe and effective for those disorders, and it has not approved compounded ketamine products for any indication or route of administration.

While "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 health care provider," the release stated.

The FDA also listed several other facts that patients and healthcare providers should consider before using compounded ketamine products, noting that any use of these products must include monitoring by a healthcare provider for potential serious adverse events. Ketamine products have been known to cause sedation or sleepiness, dissociation, and changes in vital signs, including blood pressure and heart rate.

The agency also warned that ketamine products have been known to lead to misuse and abuse, psychiatric events, respiratory depression, and lower urinary tract and bladder symptoms.

"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 FDA said, suggesting that patients and healthcare providers consider using FDA-approved ketamine (Ketalar), which has a better expected risk-benefit profile, appropriate dosing guidelines, and approved indications and routes of administration.

The agency also noted that ketamine has been approved as a Schedule III controlled substance for intravenous or intramuscular injection intended for the purposes to induce and maintain general anesthesia. Esketamine (Spravato), which includes just one of the two ketamine molecules, has been approved as a nasal spray for use in adult patients with treatment-resistant depression. This intranasal therapy was also approved for adults with major depressive disorder with acute suicidal ideation.

Any use of compound ketamine outside of those approved treatments could lead to potential safety concerns for patients, the FDA said, calling out the use of compounded ketamine at home or in coordination with a telehealth platform.

"At-home administration of compounded ketamine presents additional risks because a health care provider is not available onsite to monitor for serious adverse outcomes resulting from sedation and dissociation," the agency wrote.

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