FDA Issues Warning Letter on Compounded Ketamine

Spravato is the only FDA-approved version of ketamine that isn't injectable.

The Food and Drug Administration issued a letter this week that reminded consumers that ketamine is not FDA-approved for the treatment of any psychiatric disorder. The letter also stated that the FDA has not approved compounded versions of ketamine.

Ketamine hydrochloride is a Schedule III controlled substance that the FDA approved as an intravenous or intramuscular injection solution for induction and maintenance of general anesthesia. Ketamine is a mixture of two molecules. So far only Spravato, which includes only the esketamine molecule, is approved as a nasal spray for treatment-resistant depression.

The FDA acknowledged that consumers have become very interested in using oral versions of ketamine, which has resulted in compound drug companies creating their own versions. Compound drug companies create versions of drugs already available but specialized for various purposes. Some create unique dosage amounts, while others combine the drug with other formulations  or create a version that may be vegan or sugar-free.

The FDA stated:

Despite increased interest in the use of compounded ketamine, we are not aware of evidence to suggest that it is safer, is more effective, or works faster than medications that are FDA approved for the treatment of certain psychiatric disorders.

The letter warned that using a compounded version of ketamine without professional oversight could put patients at risk of adverse effects such as sedation (sleepiness), dissociation (disconnection between a person’s thoughts, feelings, and sense of space, time, and self), and changes in vital signs.

In addition to that warning, the FDA reminded consumers that there are known safety concerns associated with using ketamine products, including:

  • Abuse and misuse
  • Psychiatric events
  • Increases in blood pressure
  • Respiratory depression (slowed breathing)
  • Lower urinary tract and bladder symptoms

The warning letter said, “For FDA-approved ketamine (see Ketalar prescribing information), the expected benefit outweighs these risks when used at appropriate doses for FDA-approved indications and routes of administration.”

The FDA noted that additional studies were needed before it could approve ketamine as a treatment for psychological disorders. It is encouraging compounders, patients, and health care providers to report adverse events associated with compounded ketamine products to FDA’s MedWatch Adverse Event Reporting program.

Debra Borchardt

Debra Borchardt is the Co-Founder, and Executive Editor of GMR. She has covered the cannabis industry for several years at Forbes, Seeking Alpha and TheStreet. Prior to becoming a financial journalist, Debra was a Vice President at Bear Stearns where she held a Series 7 and Registered Investment Advisor license. Debra has a Master's degree in Business Journalism from New York University.

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