AGG's Due Diligence of FDA Regulations Aids ARS Pharmaceuticals in Improving Treatment for Severe Allergic Reactions By Alan G. Minsk, Bob Durkin, and Laura S. Dona A Type I severe allergic reaction can be a potentially life-threatening event requiring immediate treatment with epinephrine, the only FDA-approved medication for these reactions. Although epinephrine autoinjectors are highly effective, certain limitations can delay treatment in an emergency, including fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices.