November 12, 2023

FDA Warns of Risks with Compounded Ketamine Products

Mental health has become an important component of managing workers’ comp claims, making it crucial to keep track of larger mental health trends.

The FDA issued a warning regarding the use of compounded ketamine products for the treatment of psychiatric disorders.

Ketamine is not FDA-approved for the treatment of any psychiatric disorder. This new warning from the FDA speaks to compounded ketamine products used without monitoring by a healthcare provider, as they come with risks for sedation, dissociation, and changes in vital signs, which may put patients at risk for serious adverse events.

Known safety concerns associated with the use of ketamine products include abuse and misuse, psychiatric events, increases in blood pressure, respiratory depression, and lower urinary tract and bladder symptoms.

Compounded ketamine products have been marketed for a wide variety of psychiatric disorders such as depression, anxiety, post-traumatic stress disorder (PTSD), and obsessive-compulsive disorder, despite lacking FDA approval.

This warning is noteworthy because a new mental health development that may work its way into workers’ comp are the potential therapeutic uses for psychedelics, which have shown serious potential to treat certain mental health disorders.

However, use cases are still limited and psychedelics are not first-line therapies. For ketamine in particular, it is important to note that ketamine, like many drug products, is a mixture of two mirror-image molecules, R-ketamine and S-ketamine (arketamine and esketamine).

In 2019, the FDA did approve Spravato (esketatmine) nasal spray for treatment-resistant depression in adults and for depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior (in conjunction with an oral antidepressant).

Spravato only includes the esketamine molecule and, like all FDA-approved drugs, included unique warnings, contraindications, etc. Additionally, Spravato is a Schedule III controlled substance with an associated Risk Evaluation and Mitigation Strategy (REMS) program due to risks of serious adverse outcomes from sedation, dissociation, and abuse and misuse.

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