The Food and Drug Administration (FDA) recently released a statement regarding compounded ketamine products used for treating mental disorders. While raising legitimate safety issues associated with such use, they seem to disregard evidence showing its efficacy for treating various psychiatric conditions like depression and anxiety. Given the United States’ ongoing opioid and mental health crises, this oversight is of particular significance. As the FDA limits discussion to potential risks without acknowledging its increasing therapeutic uses, stigmatization could prevent potentially transformative treatments from reaching those most in need of them.

FDA’s Cautionary Approach

In its statement, the FDA stresses that ketamine is not approved to treat any mental disorder and raises concerns over safety, effectiveness and quality issues with compounded products that aren’t FDA-approved. While caution is certainly justified and necessary in terms of patient protection, their approach seems overly cautious given ketamine’s positive results in various clinical studies for depression, PTSD and anxiety disorders.

Opioids Are Overshadowing Other Options Available, according to research findings

Ironically, the FDA’s stringent stance against ketamine comes at a time when opioid overdose deaths caused by FDA-approved medication are devastating communities nationwide. Opioids have been approved by the FDA despite their well-known addictive potential and other side effects–thus undermining their credibility as concerns over ketamine are voiced.

Unacknowleged Evidence

According to FDA statement, there is no evidence to show that ketamine is more effective than other FDA-approved medications for treating psychiatric disorders. This claim contradicts existing research; multiple randomized controlled trials show ketamine’s rapid relief from depression and anxiety often within hours–even in cases when other treatments have failed. Furthermore, its potential in treating suicidal ideation remains unfulfilled in mental healthcare services.

Stigma and Party Drug Trope

Ketamine has long been considered a “party drug”, an image perpetuated by the FDA through their focus on risks and adverse events. By failing to acknowledge ketamine’s emerging status as an emerging therapeutic agent, the FDA perpetuates this stigma; hindering scientific discussion as well as limiting the expansion of therapeutic applications of this promising agent.

Risk Evaluation and Mitigation Strategy (REMS)

The FDA addresses REMS implementation for Spravato (esketamine), suggesting no safety program exists for compounded ketamine products. However, an absence of REMS for compounded ketamine does not imply an unsafe product – many medications regarded as safe and effective are not subject to REMS programs.

Lack of Monitoring Is an Issue

The FDA warns of how lack of monitoring puts patients at risk when using telemedicine platforms to access ketamine. While this is valid concern, monitoring issues apply not just to ketamine use but to all aspects of mental health care provided through telemedicine platforms.


Although the FDA’s safety concerns should not be underestimated, its statement on compounded ketamine appears to be unaware of many potential benefits. By perpetuating stigma and disregarding an increasing body of evidence, the FDA could be impeding progress toward combating the opioid crisis and mental health crisis. Caution should not lead to inaction; rather it should spur rigorous studies that establish its risk-benefit profile for mental disorders; only then can we responsibly increase treatment options available to millions who desperately require effective therapies.

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