The FDA issued an alert Oct. 10 to healthcare providers about dangers associated with treating psychiatric disorders with ketamine.
The agency warned that unsupervised use of ketamine products heightened the risk of dangerous psychiatric reactions and health problems, including high blood pressure, respiratory depression and urinary tract issues. Ketamine has grown in popularity as an alternative therapy for disorders such as depression, anxiety and post-traumatic stress disorder. However, only a ketamine nasal spray, esketamine, is federally approved to treat depression. All other psychiatric uses are unapproved and unregulated, though not illegal, The New York Times reported.
The warning also differentiates between supervised use of ketamine administered at clinics and online marketers who prescribe the drug via telemedicine. The use of ketamine without monitoring may put patients at risk of serious adverse events, the FDA said, including abuse and misuse of the drug.
"Despite increased interest in the use of compounded ketamine, we are not aware of evidence to suggest that it is safer, is more effective, or works faster than medications that are FDA approved for the treatment of certain psychiatric disorders," the FDA said.
Pharmaceutical executives told the Times they welcome oversight, but were concerned the lack of nuance in the FDA's guidance could lead to crackdowns by state regulators.