The Food and Drug Administration (FDA) has issued a warning regarding the potential risks associated with the use of ketamine for psychiatric disorders. In an effort to optimize patient safety, the FDA emphasizes that ketamine is not FDA approved for the treatment of any psychiatric disorder.
Ketamine, also known as ketamine hydrochloride, falls under the category of a Schedule 3 controlled substance as defined by the FDA. While it is approved by the FDA for intravenous and intramuscular injection solutions for anesthesia purposes, the agency has not established its safety and effectiveness in treating psychiatric conditions.
Despite the availability of compounded ketamine products marketed for various psychiatric disorders, the FDA urges caution due to identified safety concerns and the lack of a determined safe and effective dosing protocol.
The FDA acknowledges that the convenience of obtaining such products through telemedicine platforms and compounders for home use may be appealing to some patients. However, the absence of onsite healthcare provider monitoring increases the risk of adverse events like sedation and dissociation.
The agency advises that these factors can potentially lead to serious adverse events, misuse, and abuse, emphasizing the need for proper regulation and oversight.
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