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Auvi-Q (Kaléo; previously manufactured and marketed by Sanofi), the epinephrine auto-injector approved by the FDA in 2012 for emergency treatment of anaphylaxis and voluntarily withdrawn in 2015 due to potential inaccurate dosage delivery,1 has become available once more. According to Kaléo, improvements in the manufacturing process have addressed the concerns that led to its recall.
THE DEVICE — No changes were made to the device itself, which is about the length and width of a credit card and as thick as a smartphone. It has an automatic needle retraction system and a red safety guard at the needle-end of the device. Removal of the outer case initiates visual signals and an audio recording that provides step-by-step instructions and a 5-second countdown during the injection process. The shelf-life of the epinephrine in the auto-injector is 18 months;... more
- FDA. Updated: Sanofi US issues voluntary nationwide recall of all Auvi-Q due to potential inaccurate dosage delivery. Available at www.fda.gov. Accessed February 6, 2017.
- ES Edwards et al. Bioavailability of epinephrine from Auvi-Q compared with EpiPen. Ann Allergy Asthma Immunol 2013; 111:132.
- CA Camargo Jr. et al. Auvi-Q versus EpiPen: preferences of adults, caregivers, and children. J Allergy Clin Immunol Pract 2013; 1:266.
- T Umasunthar et al. Patients' ability to treat anaphylaxis using adrenaline autoinjectors: a randomized controlled trial. Allergy 2015; 70:855.