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An Analysis of Recent FDA Warnings About Compounded Ketamine

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The U.S. Food and Drug Administration (FDA) issued two warnings regarding compounded ketamine use on Feb. 16, 2022, and a year and a half later on Oct. 10, 2023. Ketamine is a dissociative anesthetic that is typically used to induce loss of consciousness and treat pain in both humans and animals. It has some hallucinogenic properties and is often called a dissociative anesthetic hallucinogen because it can make patients and recreational users feel detached from physical pain and the environment.

Ketamine can also induce amnesia, a sense of sedation and immobility, making it the drug of choice for bad actors looking to perpetuate sexual assault.

The FDA’s February 2022 warning was titled “FDA Alerts Health Care Professionals of Potential Risks Associated with Compounded Ketamine Nasal Spray,” while the 2023 warning was titles “FDA Warns Patients and Health Care Providers About Potential Risks Associated with Compounded Ketamine Products, Including Oral Formulations, for the Treatment of Psychiatric Disorders.”

While both warnings seem to cover a lot of the same ground, it seems the 2022 warning did not have the intended effect, necessitating the release of a second warning more than a year later. The federal agency noted that although it has approved a ketamine-containing nasal spray called esketamine (Spravato) for certain conditions, it warned that ketamine is not approved for psychiatric use.

Esketamine is currently part of the agency’s Risk Evaluation and Mitigation Strategy (REMS) program, which requires that the medication is “dispensed and administered in health care settings.” According to the FDA, esketamine cannot be provided outside of certified medical settings, and patients must remain under observation in a healthcare setting for at least two hours after they take the medication to ensure they are safe to leave.

This program is designed to house approved medications, such as Spravato, that can have severe side effects when taken outside of strict medical settings. As such, the FDA said, ketamine and compounded ketamine, which is ketamine with different dosage levels, “are not approved for the treatment of any psychiatric disorder.”

The FDA issued its first warning after it combed through April 2011 to January 2022 data from the FDA Adverse Event Reporting System and found five cases where compounded ketamine use was associated with dissociation, visual hallucinations, delusions, misuse and abuse.

Following this warning, the FDA issued another warning last October with some of the same information contained in the February 2022 warning. This warning noted that there was increased public interest in compounded ketamine as a treatment for behavioral health disorders, especially with the proliferation of telehealth providers that provide in-home ketamine services.

It stressed that “ketamine is not safe and effective” as a psychiatric disorder treatment and that the FDA wasn’t aware of any evidence suggesting that the dissociative psychedelic is safer, more effective or more fast acting than FDA-approved psychiatric treatments.

The concerns of the FDA support the position of startups such as Seelos Therapeutics Inc. (NASDAQ: SEEL) to the effect that psychedelic treatments should be used in only clinical settings where patients can be assessed prior to and after a treatment session to minimize the likelihood of adverse events.

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