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Children younger than 4 years who weigh 33 lb or more can now be prescribed neffy 1 mg (epinephrine nasal spray).
The nasal spray, used for the emergency treatment of allergic reactions, was previously only for children older than 4 years. The FDA first approved the product in September 2024 and approved the label expansion in late March.
Neffy is used to treat type 1 allergic reactions. The spray also comes in a higher-dose formulation for children and adults weighing more than 66 lb.
Seventy-nine reports of adverse events related to the product have been reported to the FDA Adverse Event Monitoring System for Drugs and Biologics since the product launch. Two thirds of these cases involved nasal pain and discomfort, headache, or runny nose. Nearly 20% reported that the drug was ineffective. Common side effects of neffy include chest and nasal congestion, throat irritation, and anxiousness, among others.
ARS also updated the label to recommend that patients and caregivers carry the product in blister packaging or in a special carrying case.
In 2021, more than 1 in 4 US children reported experiencing seasonal allergies, eczema, or food allergies, according to the CDC.
