FDA warns of unregulated use of Ketamine to treat depression

Report Issue

Please complete the required fields.

Your Name

Email

Reason (required)
This post contains broken linksPost has incorrect informationPost has spamCopyright IssueOther

Description

Submit

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 increased 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, 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 fueled by a small but growing body of research reporting breakthroughs among patients with hard-to-treat mental health problems.

Newsom vetoes decriminalization of psychedelics, calls for further study