The Food and Drug Administration (FDA) issued a warning on Tuesday about the risks associated with using compounded versions of ketamine to treat psychiatric disorders. Ketamine, a powerful anesthetic, has become popular as an alternative therapy for conditions like depression, anxiety, and post-traumatic stress disorder.
Compounded drugs are modified in a lab to fit the specific needs of an individual patient.
The FDA warned against the unsupervised use of compounded ketamine due to the increased risk of dangerous psychiatric reactions and health problems, such as elevated blood pressure, respiratory depression, and urinary tract issues.
The FDA made a distinction between supervised use of ketamine in clinics and wellness centers and the online prescribing of the drug for home use via telemedicine. They stated that patients who receive compounded ketamine products may not be adequately informed about the potential risks.
The use of ketamine for psychiatric purposes, except for esketamine, a federally approved nasal spray for treatment-resistant depression, is unapproved and unregulated. However, off-label use of ketamine is not illegal.
While ketamine has gained popularity as a club drug called Special K, it has also been increasingly used in injected ketamine-assisted therapy for hard-to-treat mental health problems. However, the lack of regulation has led to abuse. Ketamine can be addictive, and long-term use can result in significant health issues, including irreversible damage to the urinary tract.
The rise in telehealth during the pandemic has led to the emergence of online prescribers offering inexpensive ketamine products. Some companies provide large quantities of the drug after a single session, which experts warn can lead to misuse.
Dr. Joshua Berman, medical director for interventional psychiatry at Columbia University, expressed concerns about individuals using ketamine without sufficient evidence and guidance. Executives in the pharmaceutical compounding industry welcomed government oversight but worried that unclear guidance from the FDA could result in excessive actions by state regulators.
The FDA’s alert did not provide specific data on adverse reactions to ketamine. However, it referenced one case in which a patient experienced respiratory depression after taking compounded oral ketamine outside of a healthcare setting.
Dr. Steven Radowitz, chief medical officer at Nushama, a ketamine clinic in New York City, hoped that the FDA’s warning would help patients differentiate between online sellers and supervised treatments at clinics like Nushama. He emphasized that patients should not take ketamine home after treatment.