Patient testimonials and hundreds of small studies point to the prescription anesthetic ketamine as a potentially useful treatment for mental health conditions such as severe depression and suicidal thinking. But health experts are alarmed by its growing and widespread use under lax safety conditions.
Last month the U.S. Food and Drug Administration published a notice to patients and providers outlining potentially serious physical and psychological dangers from ketamine, which is frequently administered in clinics or practitioners’ offices by intravenous infusion or injection and induces a quasi-psychedelic state filled with fantastical thoughts and imagery.
The FDA also asserted that because it had only approved the use of this drug during surgery, robust clinical trials for the wide range of pain and mental health conditions it is used for are lacking.
“The overall benefit-risk profile of ketamine for treatment of psychiatric disorders is unknown,” the agency asserted. (The statement does not cover Spravato, a nasal spray delivery of a specific form of ketamine, esketamine, which the FDA approved in 2019 for adults with treatment-resistant depression when taken with antidepressants. But some research shows the spray is not as effective as the intravenous version.)
It’s not that nobody should try the drug. “Ketamine does work in a lot of people. I’ve seen it change lives,” says Sophie Holmes, a psychiatry and neurology researcher at the Yale School of Medicine who has documented positive changes in brain imaging while under the drug’s influence. But it’s definitely a case of patient beware, she says.
“Ketamine is unique in how rapid a response it provides,” says Emily Whinkin, a naturopathic physician in Seattle, who recently described significant improvements in anxiety and depression after one to six ketamine-assisted psychotherapy sessions in 18 patients at her clinic with substance use disorder.
Conditions like suicidal depression, anxiety, or post-traumatic stress disorder “are really impactful in people’s functioning and quality of life and are difficult to treat even with good psychotherapy and expert medication management,” Whinkin says.
Significant side effects
Ketamine should only be administered in settings equipped to handle medical emergencies, Holmes says, which is not generally the case for the many wellness clinics and telehealth providers adopting the drug for a wide range of mental health applications and fueling a $3 billion industry that is projected to grow 10 percent annually through the end of the decade.
Holmes says that more research is needed to better understand who might benefit from ketamine therapy, what the proper protocol should be, and, importantly, how it works. Current thinking is the drug increases the connections between synapses in the brain, allowing for new thought pathways to develop.
While some people experience only mild and fleeting nausea, headaches, or upset stomach while on the drug, others may have slowed breathing or increased blood pressure.
“If someone has a preexisting cardiac issue, this could be dangerous,” says Holmes, who notes that all prospective ketamine patients at Yale undergo an electrocardiogram heart test beforehand and their vitals are monitored during each session.
Equally crucial, some clinics also don’t provide sufficient psychological support. Patients may be frightened during the hallucinations, Whinkin says. These generally last under an hour, much shorter than for true psychedelics like psilocybin or lysergic acid diethylamide, or LSD. (To capitalize on the growing interest in psychedelic medicine, many clinics advertise ketamine as psychedelic-assisted therapy even though it is not an actual psychedelic.)

