Frequency of epinephrine use for food challenges during clinical trials


Published Online: January 15, 2015

The gold standard test for diagnosing food allergies is the oral food challenge (OFC). Food challenges are often performed to determine whether a food allergy has been lost, and several studies have reported on the safety of OFCs in these situations. However, because symptoms seen during OFC can range from mild to potentially life-threatening, this test does still involve a certain degree of risk. Increasingly, as novel treatments for food allergy are being examined in clinical trials, OFCs are being performed to confirm the persistence of food allergies—and currently, there is little information regarding the safety of OFCs performed for this reason.

In an article recently published in The Journal of Allergy and Clinical Immunology: In Practice, Noone et al. assessed the characteristics and treatment for positive OFCs performed to confirm food allergies prior to entry into clinical trials for novel treatments of food allergy.

The authors performed a retrospective chart review of OFCs from two food allergy treatment clinical trials, Food Allergy Herbal Formula-2 (FAHF-2) and Milk Oral Immunotherapy (MOIT), both conducted at the Icahn School of Medicine at Mount Sinai. Charts were reviewed for details including age, gender, concurrent medical problems such as asthma, food specific IgE levels, skin prick test results, foods used for the OFC, and symptoms and treatments given at the OFC.

A total of 74 positive OFCs were identified. Gastrointestinal symptoms were most frequently reported (97.3%), followed by skin symptoms (48.7%). Nearly 40% had symptoms during OFC that required treatment with epinephrine, and 2 of these subjects received treatment with a second dose of epinephrine. Biphasic reactions were infrequent, occurring in only 3 subjects (4%).

These results indicate that reactions to OFCs performed as part of food therapeutic trials tend to be more severe than OFCs performed to determine if a food allergy has been outgrown. Although severe reactions requiring epinephrine treatment was common, few required multiple doses of epinephrine, and biphasic reactions were infrequent. This indicates that OFCs conducted to confirm food allergies can be performed safely, but require experienced personnel who can recognize early signs and symptoms of anaphylaxis and promptly initiate treatment.


The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.

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