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American College of Clinical Pharmacology cautions against widespread off-label use of ketamine

By Brian Buntz | January 13, 2022

Ketamine

3d model of Ketamine from Wikimedia Commons

Interest in the dissociative anesthetic ketamine is surging, given its potential to treat treatment-resistant depression and other mental health disorders.

Against that backdrop, the American College of Clinical Pharmacology (ACCP) have released two policy statements advocating for stricter use of the drug. In addition, ACCP is arguing against its use in non-medical settings such as law-enforcement contexts where the drug is used as a forced sedative.

One of the ACCP statements concludes that the drug has an unfavorable risk–benefit profile. The ACCP observes that not only does ketamine have a significant potential for abuse, it has been linked to drug-drug interactions that could pose a safety risk.

Furthermore, the drug can lead to elevations in blood pressure and pulse. As a result, ACCP suggests that a licensed physician with advanced life support certification administer the drug.

A number of websites have popped up in recent years offering online consultations to provide at-home ketamine therapy.

The paper also notest that the FDA formally reviewed the use of the drug for any psychiatric indication. Psychiatric uses of the drug are also not subject to formal postmarketing surveillance.

ACCP also notes that the use of the related drug Spravato (esketamine) is available only through a restricted distribution system given its risk of serious adverse outcomes.

That drug has been associated with increases in blood pressure and embryo-fetal toxicity.

In November 2021, The New York Times ran an article highlighting the surge in interest in ketamine while also raising potential safety concerns regarding the uptick in its use to treat depression and similar conditions.

Meanwhile, the amount of data related to off-label use of the drug is growing.

For instance, the healthcare technology Osmind recently announced positive results from a retrospective real-world analysis of ketamine infusion therapy for depression published in the Journal of Affective Disorders.

Additionally, a recent Phase 2 study published The American Journal of Psychiatry found that the drug offers promise in treating alcoholism.

About The Author

Brian Buntz

The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. Before coming to WTWH, he served as content director focused on connected devices at Informa. In addition, Brian covered the medical device sector for 10 years at UBM. At Qmed, he overhauled the brand’s news coverage and helped to grow the site’s traffic volume dramatically. He had previously held managing editor roles on two of the company’s medical device technology publications. Connect with him on LinkedIn or email at bbuntz@wtwhmedia.com.

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