FDA Alert: Ketamine Is Not Approved For the Treatment of Any Psychiatric Disorder

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FDA Alert: Ketamine Is Not Approved For the Treatment of Any Psychiatric Disorder
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Ketamine may be prescribed as an off-label mental health treatment by some healthcare providers, but the drug is not FDA-approved for any psychiatric disorders. Taking compounded, non-regulated versions of ketamine could result in side effects like increased blood pressure, sedation, and urinary tract infections.

Kaitlin Sullivan is a health and science journalist based in Colorado. She's been part of multiple award-winning investigations into health topics including the international medical device industry and maternal mortality in New York City.Nick Blackmer is a librarian, fact-checker, and researcher with more than 20 years of experience in consumer-facing health and wellness content.

The drug has received previous FDA approval in some forms and is often used as an injectable anesthetic in hospitals and clinics. For example, someone who cannot take an FDA-approved version of a drug may be eligible to take a slightly altered compounded version that doesn’t include a particular non-active ingredient that the person is allergic to, such as a dye.. When drugs appear on this list, it’s legal for the roughly 7,500 licensed compounding pharmacies in the U.S. to mix, alter, or combine FDA-approved drugs with different ingredients to make up some of the supply.

But, just because off-label use of ketamine for psychiatric disorders is not illegal doesn’t mean it’s a good idea. Khan explained there needs to be more clinical trials to solidify that the potential benefits outweigh the risks before the FDA can support ketamine use for psychiatric disorders. Spravato is only approved for use at certified health care providers, and only in conjunction with antidepressant medication.

“With these obstacles in place, people are understandably finding shortcuts to getting it, and that is what is raising the alarm,” Anand toldWhile ketamine for psychiatric disorders hasn’t received FDA approval, research on the drug for mental health is still in motion.Half received a therapy called electroconvulsive therapy three times per week for three weeks; the other half received ketamine.

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