February 18, 2022

FDA warns about compounded ketamine nasal spray

If you compound ketamine nasal spray, be aware that FDA has issued an alert — not a formal warning, just a ‘be aware’ notice — that it has received “a concerning number of case reports of adverse events in recent years.”

Because some of those have been serious, the agency — claiming that 503A pharmacies under-report adverse events — is asking consumers, patients, and health care professionals to be extra vigilant and “report adverse events or quality problems experienced with the use of compounded drugs to FDA’s MedWatch Adverse Event Reporting program.”