FDA Issues Warning Highlighting Risks of Ketamine for Psychiatric Disorder Treatment
The US Food and Drug Administration (FDA) has recently addressed the growing interest in compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders. In a statement published on the FDA website, the organization emphasizes important information that patients and health care providers should know when considering these products.
Charles Raison, MD, Psych Congress Network’s Depression Section Editor, says, “The FDA’s recent warning about compounded forms of ketamine really highlights the tight rope that clinicians and patients have to walk when seeking treatment with forms of drugs that don’t have the understanding and protection provided by FDA approval.”
Ketamine, classified as a Schedule III controlled substance, is FDA-approved solely for intravenous or intramuscular injection for general anesthesia and is not approved for the treatment of any psychiatric disorder.
“FDA is aware that compounded ketamine products have been marketed for a wide variety of psychiatric disorders (eg, depression, anxiety, post-traumatic stress disorder (PTSD), and obsessive-compulsive disorder); however, FDA has not determined that ketamine is safe and effective for such uses,” the FDA said in the alert.
Compounded drugs, including ketamine products, do not have FDA approval, which means they have not undergone evaluation for safety, efficacy, or quality before reaching the market. Consequently, compounded drugs lack FDA-approved indications or routes of administration. “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 health care provider,” the FDA said.
Dr Raison, a thought leader in the field of psychedelics, shared insights on what clinicians can gather from the FDA alert. “On the one hand, we know of many patients with severe psychiatric conditions who have benefitted from oral, compounded ketamine. On the other hand, whenever people ingest powerful drugs in forms that don’t meet the high-quality standards of FDA-approved delivery forms, they risk unpredictable doses, potential impurities, and other problems.”
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The use of compounded ketamine products without proper monitoring by a health care provider can put patients at risk for serious adverse events, including sedation, dissociation, and changes in vital signs such as blood pressure and heart rate, says the FDA. Ketamine products are associated with other safety concerns, including abuse and misuse, psychiatric events, elevated blood pressure, respiratory depression, and lower urinary tract and bladder symptoms.
Dr Raison echoes these concerns and offers a look into where more research is needed. “While generally safe, ketamine has powerful acute physiological and psychological effects that can pose risks when taken in a non-supervised setting. But having said this, I don’t think we have an adequate understanding of the relevant risks and benefits to come down definitively on the pro- or con side of the use of compounded ketamine,” he said.
Dr Raison is “encouraged that the FDA is using their warning as an entreaty for clinicians and patients to provide more information on adverse events occurring in the context of compounded ketamine use.”
The FDA encourages reporting adverse events associated with compounded ketamine products to its MedWatch Adverse Event Reporting program.
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