FDA warns on compounded ketamine, lack of monitoring

FDA this week issued a statement warning of potential risks associated with compounded ketamine, including oral formulations, for treatment of psychiatric disorders. The agency had issued a previous statement on ketamine back in February 2022 related to compounded ketamine nasal sprays.

In this new statement, the agency expresses four particular concerns:

1. Ketamine is not FDA-approved for the treatment of any psychiatric disorder.
2. Compounded drugs, including compounded ketamine products, are not FDA approved.
3. Use of compounded ketamine products without monitoring by a health care provider may put patients at risk for serious adverse events.
4. FDA is not aware of evidence to suggest that compounded ketamine is safer, is more effective, or works faster than medications that are FDA approved for the treatment of certain psychiatric disorders.

It’s that third concern that seems to have necessitated the statement, but in its un-nuanced assertion that all compounded drugs are risky, “FDA once again has used a bazooka when a scalpel was needed,” said APC’s chief executive officer Scott Brunner. “Their sweeping generalizations marginalize other compounded therapies that are benefitting millions of Americans.”

APC is analyzing the agency’s statement on ketamine compounding and may issue a response. Stay tuned.