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JAMA article urges more surveillance over ketamine treatments

The JAMA (Journal of American Medical Association) Psychiatry published an article calling for more research and surveillance of ketamine treatments. Citing…

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The JAMA (Journal of American Medical Association) Psychiatry published an article calling for more research and surveillance of ketamine treatments. Citing the rapidly shifting ketamine treatments, the three doctors Samuel T. Wilkinson, MD, Joseph J. Palamar, PhD, and Gerard Sanacora, MD, PhD noted that the fast spread of off-label uses is causing concern.

Esketamine vs. ketamine

The doctors acknowledged that the US Food and Drug Administration (FDA) approved the S-enantiomer of ketamine or esketamine, as the first antidepressant in a new class for treatment-resistant depression in 2019. They point out that esketamine was approved with a strict treatment protocol enforced by a mandatory drug safety program. However, when it comes to regular ketamine, doctors have flexibility in how it is prescribed and no drug safety program exists. They also wrote, “It should be noted that compared with the large, rigorous phase 3 trials of esketamine, the clinical trials of ketamine are smaller, of comparatively short duration (typically 1 or 2 doses), and not sufficiently powered to inform clinical guidelines.”

One of the main differences is that esketamine is forbidden for at-home use by the FDA. Yet, during the COVID pandemic, many clinics began prescribing ketamine lozenges for oral administration so that patients could take the medicine at home. The article stated, “One prominent case documented a health care practitioner who obtained medical licenses in most US states and was prescribing ketamine for at-home administration to thousands of patients; this clinic was shut down by the Drug Enforcement Administration, marking the first time a federal agency has regulated ketamine clinics.”

Some industry leaders believe that the FDA will expand approval for esketamine and that will lessen the popularity of off-label ketamine use. Unfortunately, that isn’t expected anytime soon and so the off-label ketamine use is likely to continue.

Ketamine consequences

The authors noted that the recreational use of ketamine is on the rise and they fear that products from these clinics are getting diverted for that use. They say that fear is supported by evidence that the amount and total weight of illicit ketamine seized in the US on an annual basis increased substantially through 2022. The report stated, ” The number of ketamine seizures in the US increased by 349% from 2017 through 2022, while the number of ketamine poisonings reported to a national poison control center increased 81% between early 2019 and late 2021.”

They also pointed out that ketamine is easy to make in a lab and can hit the streets at a fairly low price. More troubling is that much of the seized ketamine was in powder form, meaning it might not be pharmaceutical grade and could end up with fentanyl in it.

They wrote that although ketamine is generally considered a safe anesthetic agent, misuse can lead to serious adverse outcomes. The report cited recent news events of young and otherwise healthy individuals who died from a combination of alcohol and ketamine. No doubt a reference to the actor Matthew Perry who died as a result of ketamine.

The doctors believe there should be a clinical registry for off-label therapeutic ketamine use. They also urge more focus on ketamine diversion and trafficking, targeting not only psychiatric clinics but also veterinary clinics. Finally, the doctors said, “A recent notice of special interest in related research grant applications (NOT-DA-24-10) published by the National Institute on Drug Abuse is encouraging, but we believe widespread surveillance efforts are also needed to fully understand the current ketamine landscape and to quickly detect changes in order to rapidly alert scientists and public health practitioners.”

 

 

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