FDA warns against compounded oral ketamine for psychiatric disorders

In recent years, interest in the use of oral ketamine has surged for mood disorders, thanks to the marketing efforts of companies like Mindbloom, Better U, Nue Life and Joyous. FDA released a statement describing the risks involved in taking compounded oral ketamine, noting that the dissociative anesthetic is not FDA approved for any psychiatric disorder. 

Compounded oral ketamine risks

The agency specifically warned against the use of compounded ketamine without proper medical oversight, warning that sedation, dissociation, and vital sign changes “may put patients at risk for serious adverse events.” 

The FDA’s warning included several considerations related to the use of compounded ketamine for psychiatric disorders, including its potential for abuse and misuse. The agency also noted that ketamine use could lead to psychiatric events, given its association with dissociation and hallucinations. Ketamine is structurally similar to the fellow NMDA-receptor antagonist phencyclidine (PCP, angel dust), a drug frequently associated with inducing psychosis, but, 1962, the chemist Dr. Calvin L. Stevens synthesized ketamine as a safer alternative to that drug. Ketamine has less potent psychotomimetic (psychosis-mimicking) and dissociative effects compared to PCP, and offers more flexibility as an anesthetic. Ketamine also has one-tenth the potency of PCP. 

FDA also noted that ketamine can cause blood pressure increases, which could pose a risk for individuals with hypertension. Other potential adverse events from ketamine include respiratory depression.

Additionally, the FDA warned of the potential for lower urinary tract and bladder symptoms associated with ketamine use. It noted established safe or effective dosing for psychiatric indications is lacking, as ketamine has not been approved for these indications. 

The pandemic helped stoke interest in telehealth ketamine

Telehealth-based prescription of ketamine has grown in part as a result of the COVID-19 Public Health Emergency (PHE), which loosened requirements for in-person visits for controlled substances. Ketamine is a schedule III drug, in the same class as low-dose codeine and testosterone.  

Some professional organizations and journalists have called for increased scrutiny of at-home ketamine use as a result of safety and effectiveness concerns. After its debut in the 1970s, ketamine became a party drug in the following decades. Abuse of the drug receded in the 2000s