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.
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.and a ketamine blood level that appeared to be twice what a person would typically receive as anesthesia, the FDA said.
“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 Spravato REMS requires esketamine to be dispensed and administered in medically supervised health care settings that are certified in the REMS. They must agree to monitor patients for at least two hours because of possible sedation and out-of-body sensations as well as the potential for misuse and abuse.
At-home administration of these products is especially risky because of the lack of monitoring for adverse outcomes, the FDA said.
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