WEDNESDAY, Oct. 11, 2023 (HealthDay News) — The U.S. Food and Drug Administration is warning consumers about risks of using compounded versions of the drug ketamine, often taken for psychiatric disorders. Compounded products are not evaluated by the FDA for safety and effectiveness. They are also not regulated like approved drugs, so they present a greater risk.
“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 health care provider,” the FDA said in a news release.
The agency offered an example of a concerning case reported about a patient in April. That person had taken compounded oral ketamine outside of a health care setting for the treatment of posttraumatic stress disorder (PTSD). The result was slowed breathing and a ketamine blood level that appeared to be twice what a person would typically receive as anesthesia, the FDA said.
Patients are increasingly interested in taking compounded ketamine products, including oral formulations, for mental health disorders, such as depression, anxiety, PTSD, and obsessive-compulsive disorder, according to the FDA. Known safety concerns associated with the drug are abuse and misuse, psychiatric events, increases in blood pressure, slowed breathing, and lower urinary tract and bladder symptoms.
In the FDA-approved version of ketamine, the expected benefit outweighs these risks when used at appropriate doses. “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.
The FDA said it understands that getting compounded products through telemedicine platforms and compounders for at-home use may be attractive to some patients, but it reiterated the risk. At-home administration of these products is especially risky because of the lack of monitoring for adverse outcomes, the FDA said. Using compounded products outside a health care setting means there is no monitoring of sleepiness; dissociation or disconnection between a person’s thoughts, feelings, and sense of time, space, and self; as well as changes in vital signs, including blood pressure and heart rate.
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