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FDA Issues Alert Regarding Risks of Compounded Ketamine Nasal Spray Use
The US Food and Drug Administration recently issued an alert to healthcare professionals regarding potential risks associated with the use of compounded ketamine nasal spray, which is not FDA-approved and has not been evaluated by the administration for safety, effectiveness, or quality prior to marketing.
The FDA said it has received “a concerning number of case reports of adverse events in recent years” involving compound nasal spray formulations of ketamine, either alone or in combination with other ingredients. The administration searched its Adverse Event Reporting System databased from April 2011 to January 2022 and identified 5 cases between 2016 and 2021 in which patients had psychiatric events, such as delusion, disassociation, visual hallucination, and panic attack, as well as misuse and abuse. Frequency of use varied from 3 sprays, 3 times per day to 6 sprays, 8 times per day, with amounts of the medication administered per spray unknown. In most cases, the product was administered at home.
“[C]ompounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug,” the FDA wrote in its alert. “The dispensing of compounded ketamine nasal spray for home use when safe and effective dosing for psychiatric indications has not been established may place the patient at risk for serious psychiatric adverse events, misuse, and abuse.”
FDA also encouraged consumers, patients, and healthcare professionals to report adverse effects or quality problems experienced with compounded drug use to its MedWatch Adverse Event Reporting program.
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