Background
Previous studies report epinephrine use for positive oral food challenges (OFCs) to be 9–11% when generally performed to determine outgrowth of food allergies. Epinephrine use for positive OFCs performed as screening criteria for enrollment in therapeutic trials for food allergy has not been reported.
Objective
To assess the characteristics and treatment for positive OFCs performed for screening subjects for food therapeutic trials.
Methods
Retrospective review of positive screening OFCs from two treatment trials, Food Allergy Herbal Formula-2 (FAHF-2) (n=45) and Milk Oral Immunotherapy (MOIT) (n=29) conducted at the Icahn School of Medicine at Mount Sinai was performed.
Results
The most common initial symptom elicited was oral pruritus, reported for 81% (n=60) of subjects. Overall, subjective gastrointestinal symptoms (oral pruritus, throat pruritus, nausea, abdominal pain) were most common (97.3% subjects), followed by cutaneous symptoms (48.7%). Of the 74 positive DBPCFCs, 29 (39.2%) were treated with epinephrine; 2 of these subjects received 2 doses of epinephrine (6.9% of the reactions treated with epinephrine or 2.7% of all reactions). Biphasic reactions were infrequent, occurring in 3 subjects (4%).
Conclusions
Screening OFCs to confirm food allergies can be performed safely, but there was a higher rate of epinephrine use compared to OFCs used for assessing food allergy outgrowth. Therefore, personnel skilled and experienced in the recognition of early signs and symptoms of anaphylaxis who can promptly initiate treatment are required.
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