FDA Issues Warning Letter for Ketamine

The FDA has issued a warning letter regarding the use of ketamine outside of FDA-approved conditions. This notice seems to be in response to the growing use of ketamine for the treatment of mental health conditions.

With the increased and un-regulated use of ketamine to treat mental health conditions (outside of ketamine’s original FDA approval) there have been growing concerns of misuse, abuse, and other potential dangers — the likely motivation behind this letter.

The FDA is generally supportive of ketamine development, so this warning shouldn’t be taken as a sign of the FDA growing sour on ketamine. For example, PharmaTher has recently received 5 different FDA orphan drug designations for its ketamine developments.

With ketamine increasing in medical and recreational use, this letter is a good opportunity to review some of the basics of ketamine in both its FDA-approved and “off-label” use. Here are some highlights from the FDA’s notice with additional context (some points taken directly from the letter):

• Ketamine is a Schedule III controlled substance FDA-approved as an intravenous or intramuscular injection for general anesthesia.

• Ketamine is not FDA approved for the treatment of psychiatric disorders. Despite it being used “off-label” for mental health conditions, the FDA has not approved ketamine as safe and effective for such uses.

• Ketamine products used by clinics and telehealth providers are “compounded” ketamine, not the FDA-approved version of the drug.

• Drug compounding is the process of combining, mixing, or altering approved ingredients to create a tailored medication. In some cases, they can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product.

• Compounded drugs, including compounded ketamine products, are not FDA-approved, which means the FDA has not evaluated their safety, effectiveness, or quality prior to marketing.

• Use of compounded ketamine products without monitoring by a health care provider for sedation (sleepiness), dissociation (disconnection between a person’s thoughts, feelings, and sense of space, time, and self), and changes in vital signs (such as blood pressure and heart rate) may put patients at risk for serious adverse events.

• Spravato (which includes only the esketamine molecule), is the only FDA-approved ketamine product for mental health conditions; a nasal spray for treatment-resistant depression in adults with major depressive disorder with acute suicidal ideation (in conjunction with an oral antidepressant).

For more on ketamine’s increased use and potential issues, check out A Deeper Look at Ketamine and its Potential for Addiction

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