The Food and Drug Administration issued an alert on Tuesday about the dangers of treating psychiatric disorders with compounded versions of ketamine, a powerful anesthetic that has become increasingly popular among those seeking alternative therapies for depression, anxiety, post-traumatic stress disorder and other difficult-to-treat mental health problems.
Compounded drugs are those that have been modified or tailored in a lab for the specific needs of an individual patient.
The agency, citing reports it had received of adverse incidents, warned that the unsupervised use of compounded ketamine heightened the risk of dangerous psychiatric reactions and health problems like increased blood pressure, respiratory depression and urinary tract issues that can lead to incontinence.
The warning sought to differentiate between the supervised use of ketamine as a psychiatric therapy administered at clinics and “wellness centers,” and online marketers who prescribe the drug via telemedicine so that buyers can take the drug at home.
“Patients who receive compounded ketamine products from compounders and telemedicine platforms for the treatment of psychiatric disorders may not receive important information about the potential risks associated with the product,” the F.D.A. said in its warning.
With the exception of esketamine, a federally approved ketamine nasal spray for treatment-resistant depression, the psychiatric use of ketamine is unapproved and unregulated, though so-called off-label use of ketamine is not illegal.
Since it was first approved as a battlefield anesthetic in 1970, ketamine has also gained popularity as Special K, a club drug that is usually snorted. More recently, there has been an explosion in injected ketamine-assisted therapy, much of it fueled by a small but growing body of research reporting breakthroughs among patients with hard-to-treat mental health problems.
But the regulatory vacuum has also opened the door to mounting abuse. Ketamine can be addictive, and heavy, long-term use can lead to significant health problems, including irreversible urinary tract damage.
The pandemic-related boom in telehealth has given rise to a legion of online prescribers that dispense inexpensive ketamine lozenges, tablets or nasal sprays following a brief video interview. Some companies provide as many as 30 doses after one session, which experts say can lead to misuse.
“Whenever you have something new, there may be people who run ahead with it. And there will be people who do things based on less evidence rather than more,” said Dr. Joshua Berman, medical director for interventional psychiatry at Columbia University, who helped develop the department’s ketamine program.
Executives in the pharmaceutical compounding industry said they welcomed government oversight but expressed concern that a lack of nuance in the F.D.A.’s guidance could lead to overzealous crackdowns by state regulators, who have jurisdiction over the nation’s compounding facilities.
“Our concern is that these online sellers are going to ruin it for everybody,” said Peter Koshland, who runs a compounding pharmacy in San Francisco. “Our fear is that regulators, if they perceive a threat to public health, will move to take this amazing medicine away and leave patients at risk.”
The F.D.A. alert did not include data about adverse reactions among ketamine users. It cited a single case from April of a patient with post-traumatic stress disorder who experienced respiratory depression after taking compounded oral ketamine outside of a health care setting. The patient’s ketamine blood level, the agency said, was twice the amount typically used in anesthesia.
The F.D.A. declined to make an official available for an interview.
Dr. Steven Radowitz, chief medical officer at Nushama, a ketamine clinic in New York City that administers the drug via injection, said he hoped the alert would help patients differentiate between companies that sell the drug online and those whose treatments are accompanied by strict supervision. At Nushama, he said, the treatment protocol includes six ketamine treatments over the course of three weeks, and an in-house staff that includes doctors, nurse practitioners and therapists.
“No one goes home with ketamine,” Dr. Radowitz said. “And that’s the way it should be.”