October 20, 2017 — Editor’s note: This article has been updated from its previous versions.
The seemingly ever-expanding business of off-label ketamine infusion therapy for treatment-resistant depression (TRD), along with a host of other conditions, appears to be unchecked by any regulatory or legislative oversight ― raising both ethical and safety concerns among clinicians and medical organizations.
“It scares the hell out of me that this is still unregulated,” Steve Levine, MD, a psychiatrist and the founder and CEO of Actify Neurotherapies, a 10-clinic network that offers ketamine infusions, told Medscape Medical News.
Although ketamine has only been approved by the US Food and Drug Administration (FDA) for use as an anesthetic, it has shown effectiveness in the research setting for TRD. However, off-label infusions are being promoted by some clinics almost as a cure-all with little risk. Read more.
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