FDA Issues Warning Over Ketamine Misuse, DEA Extends Telemedicine Flexibilities

The Food and Drug Administration (FDA) issued an alert on the dangers of self-treating psychiatric disorders with unapproved compounded versions of ketamine and ketamine-based drugs whether modified or tailored for specific patient needs.

In view of the anesthetic’s rising popularity as an alternative mental health treatment, the FDA’s alert cites a report of adverse incidents and warns that the unsupervised use of these substances increases risks of unfavorable psychiatric reactions and other health problems.

Specifically, it notes an April-reported case of a patient with PTSD who took oral compounded ketamine outside of healthcare supervision and subsequently experienced slowed breathing,  also known as respiratory depression, and a higher level of ketamine in blood than usual -reportedly twice the amount typically used in anesthesia.

Although the document did not include any further data on adverse reactions among ketamine users, its stated aim is to distinguish in-clinic administered and supervised psychiatric use from telemedicine “marketers” prescribing different versions of it as a take-home therapy without providing patients with “important information about the potential risks associated with the product.”

Currently, except for the nasal spray esketamine for Treatment-Resistant Depression (see Harvard’s Dr. Grinspoon’s comment) ketamine’s psychiatric use is federally unapproved and unregulated. Its off-label use is not illegal, posing a regulatory loophole that has frequently resulted in its misuse and consequent health complications.

DEA Extends Telemedicine Flexibilities

In related ketamine news, the DEA announced on October 6 that, for a second time, it is extending pandemic-established temporary rules deviating from the Ryan Haight Act conditions and effectively allowing telehealth prescriptions of controlled medications through December 31, 2024.

As the COVID public health emergency allowing for the exception approached its May 11 end date, the federal agency received over 38,000 public comments on two proposals regarding telehealth’s flexibility and extended it throughout November 11 to go over them and further organize a sustainable healthcare framework.

This second extension, decided jointly by the DEA and HHS, followed two days of public hearings. The ruling will apply to every telehealth patient-practitioner relationship, not just those that begin prior to or on Nov. 11.

Photo: Benzinga edit with photo by PopTika and luchschenF on Shutterstock.