The Food and Drug Administration warns people to stay away from unapproved sources of ketamine. The agency said compounded ketamine is increasingly being sold as a treatment for depression and other mental health problems, even though it has not been tested or approved for such use. The FDA also said it continues to receive reports that people may have been 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 used as a treatment for depression and suicidal thoughts. In 2019, the FDA officially approved Spravato is a ketamine-based nasal spray developed by Johnson & Johnson. The active ingredient in Spravato is a chemical brother of ketamine known as esketamine (ketamine consists of two molecular forms, one of which is esketamine).
Ketamine itself is not approved to treat depression. However, doctors have some discretion to prescribe the drug for conditions outside of its approved label, known as off-label use. Before and after Supravat’s approval, some clinicians were prescribing classic ketamine for depression. Because this drug can cause potentially harmful complications such as dissection, these treatments are often given through an IV in a specialized clinic under the supervision of a health care provider. Also, Suprabat is clearly regulated so that it can only be taken under the supervision of a doctor. But the FDA has apparently noticed that an increasing number of people are being given ketamine in less safe settings.
Last year, the agency issued Alerts warning you about the risks of ketamine manufactured by some compounding pharmacies (pharmacies that are allowed to create custom medications for patients with special needs, such as certain allergies). The warning cites several adverse event reports regarding people taking compounded ketamine nasal spray formulations at home. These products are often marketed and sold through telemedicine companies, the agency added.
In the latest alert, released On Tuesday, the FDA noted that compounded ketamine is currently sold in sublingual (dissolved under the tongue) and oral dosage forms for depression. The FDA is concerned that people taking combination ketamine may do so without any supervision or clear knowledge of the potential risks. The dosages of ketamine offered at these pharmacies can also vary widely, and there are no established guidelines regarding the optimal dosage to be given when taken in these forms, which further increases the risk of harm. .
For example, in April 2023, the agency received a report of a person who experienced respiratory depression (breathing slows or stops) after taking combination oral ketamine to treat PTSD outside of a medical facility. The person’s blood ketamine levels were reportedly twice the levels normally seen during anesthesia in hers. Other adverse events associated with combination ketamine include psychosis, increased blood pressure, and lower urinary tract and bladder symptoms. Although adverse event reports are not conclusive evidence that a product is harmful, they provide valuable signals of potential safety risks.
scientists legitimately excited About the potential of ketamine-based treatments for depression and other mental health conditions.And part of the popularity of combination ketamine appears to be due to its lower cost compared to Spravat (without insurance coverage, the drug is costs go up Although it costs $800 for two doses, the formulated nasal ketamine is There will be a cost ($50 per bottle). But there is no doubt that people are taking a gamble by turning to less safe drug sources.
“Despite the growing interest in the use of combination ketamine, evidence suggests that ketamine is safer, more effective, and faster-acting than FDA-approved drugs to treat certain mental disorders. we do not know,” the authorities wrote. That warning.
