Other safety alerts
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| The United States: FDA alerts health care professionals of potential risks associated with compounded ketamine nasal spray |
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The US Food and Drug Administration (FDA) announces that it has become aware of safety reports involving compounded intranasal ketamine to treat psychiatric disorders which may be putting patients at risk. Compounded drugs are not FDA-approved, which means FDA has not evaluated their safety, effectiveness, or quality prior to marketing.
FDA is aware that some pharmacies compound nasal spray formulations of ketamine either alone or in combination with other ingredients, and there have been a concerning number of case reports of adverse events in recent years. Given these reports and the lack of standardized safety measures associated with the use of compounded ketamine nasal sprays, patients may be at risk of serious adverse events and potential misuse and abuse. FDA is issuing this alert due to the increased awareness of adverse events reported, the seriousness of these adverse events, and the likelihood that adverse events related to compounded drug products are under-reported.
FDA searched the FDA Adverse Event Reporting System (FAERS) database and the medical literature from Apr 2011 through Jan 2022 and identified five cases, reported between 2016 to 2021, associated with psychiatric events such as delusion, dissociation, visual hallucination, and panic attack as well as abuse and misuse following the use of compounded ketamine nasal spray. The reported concentrations of compounded ketamine nasal spray ranged from 125 to 200 mg/ml. Frequency of use varied from three sprays three times a day to six sprays eight times a day. The amount of medication administered to the patients with each spray is unknown. In most case reports, the patients self-administered the product at home, and it is unknown whether they were observed or monitored by a healthcare professional.
There is no FDA-approved ketamine nasal spray product. 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. Healthcare professionals should be advised that animal studies have shown an association between racemic ketamine and brain lesions, and that the implications of the animal findings to humans are unknown. FDA recommends that healthcare professionals be aware of the potential risks associated with compounded ketamine nasal spray.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-professionals-potential-risks-associated-compounded-ketamine-nasal-spray
In Hong Kong, the above compounded product is not a registered pharmaceutical product.
Ends/Thursday, Feb 17, 2022
Issued at HKT 15:00
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