The US Food & Drug Administration has flagged the increasing use of compounded ketamine products for treating disorders like depression, anxiety, PTSD and OCD, reminding patients and providers that it has not issued approval of the products for any of these psychiatric conditions.
Although compounded drugs can serve an important medical need for certain patients when an FDA-approved drug is not medically appropriate, they also present a risk to patients and should only be used under the care of a healthcare provider, the agency said, notes MedicalBrief.
Use of compounded ketamine products without monitoring by a healthcare provider for sedation (sleepiness), dissociation (disconnection between a person’s thoughts, feelings, and sense of space, time and self), and changes in vital signs (such as blood pressure and heart rate) may put patients at risk for serious adverse events, warned the agency.
Known safety concerns associated with ketamine products include abuse and misuse, psychiatric events, increases in blood pressure, respiratory depression (slowed breathing), and lower urinary tract and bladder symptoms.
The agency added that for FDA-approved ketamine, the expected benefit outweighs the risks when used at appropriate doses for FDA-approved indications and routes of administration.
Despite increased interest in the use of compounded ketamine, it said it was not aware of evidence to suggest that it was safer, more effective, or worked faster than medications that were FDA-approved for the treatment of certain psychiatric disorders, it said.
Last year, the FDA published a compounding risk alert describing the potential risks associated with at-home use of compounded ketamine nasal spray and several adverse event reports.
Since then, it has become aware of increasing public interest in the use of sublingual and oral dosage forms of compounded ketamine for treating psychiatric disorders.
It warned that patients who receive compounded ketamine products from compounders and telemedicine platforms for treatment of psychiatric disorders may not receive important information about potential risks linked to the product.
At-home administration of these products presented additional risks because a healthcare provider is not available onsite to monitor for serious adverse outcomes resulting from sedation and dissociation.
In April 2023, FDA received an adverse event report of a patient suffering respiratory depression after taking compounded oral ketamine – for the treatment of PTSD – outside a healthcare setting. The patient’s ketamine blood level appeared to be twice the blood level typically obtained for anaesthesia.
The FDA reiterates that ketamine is not approved for the treatment of any psychiatric disorder, and additional clinical studies are needed to adequately investigate its benefit-risk profile and safe-use conditions for treating these disorders.
See more from MedicalBrief archives:
Ketamine better than ECT for depression – Harvard study
Ketamine for the treatment of mental health and substance use disorders – Meta-analysis
UK licences radical ketamine-like drug to treat depression
Ketamine clinic boom in US triggers concerns over 'quick buck' training