Epinephrine use in positive oral food challenges performed as a screening test for food allergy therapy trials

J Allergy Clin Immunol Pract. May-Jun 2015;3(3):424-8. doi: 10.1016/j.jaip.2014.10.008. Epub 2015 Jan 13.


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: The objective of this study was 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 2 treatment trials, food allergy herbal formula-2 (n = 45) and milk oral immunotherapy (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 double-blind, placebo-controlled food challenge, 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, which occurred 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 with 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.

Trial registration: ClinicalTrials.gov NCT00602160 NCT01157117.

Keywords: Anaphylaxis; Epinephrine; Food allergy; Positive oral food challenge.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Anaphylaxis / diagnosis*
  • Anaphylaxis / drug therapy*
  • Anaphylaxis / immunology
  • Anti-Allergic Agents / therapeutic use*
  • Child
  • Clinical Competence
  • Clinical Trials as Topic
  • Epinephrine / therapeutic use*
  • Female
  • Food Hypersensitivity / diagnosis*
  • Food Hypersensitivity / drug therapy*
  • Food Hypersensitivity / immunology
  • Humans
  • Immunologic Tests / adverse effects*
  • Male
  • Milk Hypersensitivity / diagnosis
  • Milk Hypersensitivity / drug therapy
  • Milk Hypersensitivity / immunology
  • Predictive Value of Tests
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Treatment Outcome
  • Young Adult


  • Anti-Allergic Agents
  • Epinephrine

Associated data

  • ClinicalTrials.gov/NCT00602160
  • ClinicalTrials.gov/NCT01157117