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Medical Professionals Reference (MPR)Safety Concerns Prompt FDA Warning for Compounded Ketamine Products

Unmonitored Use of Compounded Ketamine Poses Serious Risks

The Food and Drug Administration (FDA) has recently issued a warning about the potential risks associated with the use of compounded ketamine products, particularly oral formulations, for the treatment of psychiatric disorders. This alert comes in the wake of an adverse event report from April 2023.

HCN Medical Memo
The FDA’s warning about the potential risks of compounded ketamine products underscores the importance of healthcare professionals being vigilant about the medications their patients are using. This information could significantly impact their practice and patient care, particularly in relation to patients with psychiatric disorders. It’s crucial to consider the broader context of healthcare and the potential paradigm shifts that these findings could indicate.

Key Points

  • Compounded ketamine products are not FDA-approved and have not been evaluated for safety, efficacy, or quality.
  • An adverse event report from April 2023 involved a patient experiencing respiratory depression after taking compounded oral ketamine to treat post-traumatic stress disorder (PTSD) outside of a health care facility.
  • The patient was reported to have double the ketamine blood levels typically obtained for anesthesia.
  • Risks associated with taking compounded ketamine include abuse and misuse, psychiatric events, increases in blood pressure, respiratory depression, and lower urinary tract and bladder symptoms.
  • Patients who use these products without monitoring by a health care provider are at serious risk for adverse outcomes resulting from sedation and dissociation.

Although ketamine use among high school seniors was only 0.9% in 2021, those who did were more likely to have problems with depression than those consuming other drugs like cannabis. Those who consumed it three to nine times were 65% more at risk, and those who took it over ten times were 70% more prone to severe depression.

Ketamine Facts, Statistics & Myths 2023 (

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