US FDA issues warning over misuse of ketamine
Sign up now: Get ST's newsletters delivered to your inbox
There has been an explosion in injected ketamine-assisted therapy, much of it fuelled by a small but growing body of research reporting breakthroughs among patients with hard-to-treat mental health problems.
PHOTO: NYTIMES
WASHINGTON – The United States Food and Drug Administration (FDA) issued an alert on Tuesday about the dangers of treating psychiatric disorders with compounded versions of ketamine, a powerful anaesthetic 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 laboratory for the specific needs of an individual patient. The agency warned that the unsupervised use of compounded ketamine heightened the risk of dangerous psychiatric reactions and health problems such as increased blood pressure, respiratory depression (slow breathing rate), 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 centres”, 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 FDA warning said.
With the exception of esketamine, a federally approved ketamine nasal spray for treatment-resistant depression, psychiatric use of ketamine is unapproved and unregulated, although 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 fuelled 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.
The FDA alert cited a single case in April of a patient with post-traumatic stress disorder who experienced respiratory depression after taking compounded oral ketamine outside a healthcare setting. The patient’s ketamine blood level, the agency said, was twice the amount typically used in anaesthesia. NYTIMES