FDA warns people to stay away from compound ketamine

The Food and Drug Administration is warning people to stay away from unapproved sources of ketamine. According to the agency, compounded ketamine is increasingly sold as a treatment for depression and other mental health problems, despite not having been tested or authorized for such uses. The FDA also says it continues to receive reports of people possibly being harmed by these products.

Ketamine is a dissociative anesthetic that has been used as a sedative and recreational drug for decades. In recent years, it has also started to be administered as a treatment for depression and suicidal ideation. In 2019, the F.D.A. officially approved a ketamine-based nasal spray developed by Johnson & Johnson called Spravato. The active ingredient in Spravato is a chemical sibling of ketamine known as esketamine (ketamine is made up of two molecular forms, one of which is esketamine).

Ketamine itself is not approved for treating depression. But doctors have some freedom to prescribe medications for conditions outside of approved indications, which is known as off-label use. Before and after Spravato’s approval, some doctors prescribed the classic version of ketamine for depression. These treatments are often performed by infusion in specialized clinics under the supervision of doctors, as the medication can cause potentially harmful complications, such as dissociation. Spravato is also explicitly regulated so that it can only be taken under medical supervision. But the FDA has apparently noticed an increase in the number of people receiving ketamine in less safe circumstances.

Last year, the agency published an alert warning about the risks of ketamine being produced by some compounding pharmacies that are allowed to create personalized medicines for patients with special needs, such as those with certain allergies. The alert referred to several reports of adverse events from people taking compounded ketamine nasal spray formulations at home. These products are often marketed and sold through telemedicine companies, the agency added.

In your last warning,released Tuesday, the FDA notes that compound ketamine is now being sold in sublingual (dissolved under the tongue) and oral forms for depression. The FDA is concerned that people who take compounded ketamine may do so without any supervision and/or clear knowledge of its potential risks. The dosages of ketamine provided by these pharmacies can also vary widely, and there are no established guidelines for the ideal dosages that should be administered when taken in these forms, which further increases the risk of harm.

In April 2023, for example, the agency received a report of someone experiencing respiratory depression (slow or stopped breathing) after taking compounded oral ketamine for their PTSD outside of a medical setting. The person reportedly had a blood ketamine level twice the level normally seen when used for anesthesia. Other adverse events associated with compounded ketamine include psychiatric events and increased blood pressure, as well as lower urinary tract and bladder symptoms. Adverse event reports are not damning evidence that a product is harmful, but they do provide a valuable signal of potential safety risks.

Scientists are legitimately excited about the potential of ketamine-based therapies for depression and other mental health conditions. And it’s likely that compounded ketamine’s popularity is due in part to its cheaper cost compared to Spravato (without insurance coverage, the drug can cost upward of US$800 for two doses, while compound nasal ketamine can costs around US$50 a bottle). But people are definitely gambling by turning to less safe supplies of the drug.

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

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