FDA Issues New Warning Regarding Compounded Ketamine
On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert regarding the potential risks associated with compounded ketamine nasal spray. The October 10 warning notes that even though there has been widespread marketing for ketamine to treat psychiatric disorders (e.g., depression, anxiety, post-traumatic stress disorder (PTSD), and obsessive-compulsive disorder), the FDA has not approved ketamine for any of these indications.
Drug compounding is the process of combining, mixing, or altering ingredients (usually in two or more drugs) to create a medication tailored to the needs of an individual patient. Although the reason to use compounded drugs varies, often a patient will receive compounded drugs if they cannot be treated with an FDA-approved medication.
The FDA reminded health care providers that the administration has not assessed ketamine to treat psychiatric indications, and that the FDA does not have authority to regulate the compounding process to ensure quality, safety, and effectiveness. Because compounded ketamine has not been FDA approved for these indications, the FDA notes that it has not established safety, including safe dosing regimens, of the drug. As such, the FDA warns that without monitoring by a health care provider, compounded ketamine places patients at risk for serious adverse events, misuse, and/or abuse, especially where there is home use of the product. Additionally, FDA cautions that patients who receive compounded ketamine products may not receive important information about the potential risks associated with ketamine use for these indications. In addition to not undertaking a safety and efficacy assessment of ketamine for these indications, FDA has no mechanism for undertaking post-use patient monitoring.
Finally, the FDA emphasizes that despite increased interest in the use of ketamine for these indications, the agency is not aware of any evidence that it is safer, more effective, or works faster than medications that are FDA approved for the treatment of certain psychiatric disorders.
Although just a warning, this alert means that the FDA is focusing its attention on compounded ketamine and potential dangers to patients. Given this warning, we encourage health care providers (and specifically telemedicine providers) who may offer compounded ketamine to patients to ensure that they do not misrepresent in any way what is known about the benefits of ketamine use to treat psychiatric disorders. Specifically, providers must inform patients of all important information regarding use of compounded ketamine, including risks associated with use and lack of FDA approval for use when treating psychiatric disorders. Additionally, if providers prescribe ketamine for these indications, they must ensure that patients receive proper monitoring after using compounded ketamine because the FDA has received adverse event reports of patients who have taken compounded ketamine outside of health care settings. This is particularly important for telemedicine providers who may not have a physical location where they can easily monitor patients’ vitals. We encourage any providers (and especially telemedicine providers) who offer compounded ketamine to ensure they have a compliance plan in place that requires patients receive necessary information and an appropriate level of monitoring, while minimizing any potential risks of adverse events.
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