FDA warns people to stay away from compounded ketamine

The Food and Drug Administration warns 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 conditions, although it has not been tested or approved for such uses. The FDA also says it continues to receive reports of people who may be harmed by these products.

Ketamine is a dissociative anesthetic that has been used as both a sedative and recreational drug for decades. In recent years, it has also begun to be administered as a treatment for depression and suicidal ideation. In 2019, the FDA officially approved a ketamine 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 to treat depression. But doctors have some leeway to prescribe drugs for conditions outside of their approved indications, known as off-label use. Before and after Spravato’s approval, some clinicians prescribed the classic version of ketamine for the treatment of depression. Often, these treatments are administered by infusion in specialized clinics under the supervision of medical providers, because the medication can cause potentially dangerous complications like 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 people receiving ketamine under less safe circumstances.

Last year, the agency issued an alert regarding the risks of ketamine produced by certain pharmaceutical pharmacies authorized to create personalized medications for patients with special needs, such as certain allergies. The alert referenced several reports of adverse reactions occurring in people taking compounded ketamine nasal spray formulations at home. These products are often marketed and sold through telemedicine companies, the agency added.

In his final warning,released On Tuesday, the FDA noted that compounded ketamine is now sold in sublingual (dissolved under the tongue) and oral forms for the treatment of depression. The FDA is concerned that people taking compounded ketamine may do so without any supervision and/or without clear knowledge of its potential risks. Doses of ketamine provided by these pharmacies can also vary widely, and there are no established guidelines regarding the optimal doses to administer when taken in these forms, further increasing the risk of harm.

In April 2023, for example, the agency received a report of a person experiencing respiratory depression (slowing or stopping breathing) after taking compounded oral ketamine for their PTSD outside of a medical setting . The person would have had a level of ketamine in the blood twice as high as the level generally observed during 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 definitive proof that a product is harmful, but they provide a valuable signal about potential safety risks.

The scientists are legitimately excited on the potential of ketamine-based therapies to treat depression and other mental health conditions. And it’s likely that compounded ketamine’s popularity is partly due to its cheaper cost than Spravato (without insurance coverage, the drug can rising cost of $800 for two doses, while compounded nasal ketamine can cost around $50 a bottle). But people are definitely taking a gamble by turning to less safe supplies of the drug.

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