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Cited by 157Drug-Induced Adverse ReactionsFood Allergy and Anaphylaxis ResearchPharmacovigilance and Adverse Drug Reactions

Safety and outcomes of oral graded challenges to amoxicillin without prior skin testing.

Iammatteo, Melissa, Alvarez Arango, Santiago, Ferastraoaru, Denisa, Akbar, Nadeem, Lee, Andrew Y., Cohen, Hillel W., Jerschow, Elina·2019·The Journal of Allergy and Clinical Immunology In Practice
DOI 10.1016/j.jaip.2018.05.008
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Abstract

Background Unconfirmed penicillin allergy poses substantial public health consequences. The most widely accepted protocol to evaluate penicillin allergy is skin testing followed by an amoxicillin challenge.Objective To evaluate the safety of direct oral graded challenges to amoxicillin.Methods A prospective single-blind clinical trial with historical controls of patients ≥7 years old with historical non-life-threatening reactions to penicillin was conducted. Patients received placebo followed by a 2-step graded challenge to amoxicillin. The allergic reaction rate was compared with the rate observed in our previous study that included skin testing and with the currently reported penicillin allergy prevalence in the US population.Results Of the 155 participants who completed an amoxicillin challenge, 120 patients (77.4%) experienced no reaction whereas 31 patients (20%) experienced nonallergic reactions to either placebo (n = 16) or amoxicillin (n = 15). Four patients (2.6%) developed mild allergic reactions. Significantly (P = .03) fewer patients (4 of 155, 2.6%, 95% confidence interval [CI]: 1.0%, 6.5%) were determined to be allergic compared with 14 of 170 subjects (8.2%, 95% CI: 5.0%, 13.4%) in our previous study where patients were determined to be allergic based on either positive skin tests (n = 11) or allergic challenge reactions after negative skin tests (n = 3). This 2.6% reaction rate was also significantly less than the 10% reported US prevalence of penicillin allergy (P = .003).Conclusions Placebo-controlled oral graded challenges to amoxicillin without prior skin testing may be safe for patients ≥7 years old with non-life-threatening historical reactions to penicillin. Amoxicillin can be tolerated by the majority of patients with self-reported penicillin allergy.

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  • In studies that have incorporated penicillin skin testing and graded oral challenge among persons with reported penicillin allergy, the true rates of allergy are low, ranging from 1.5% to 6.1%.

    “Moreover, in studies that have incorporated penicillin skin testing and graded oral challenge among persons with reported penicillin allergy, the true rates of allergy are low, ranging from 1.5% to 6.1% (665–667).”

    From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [667]

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Authors
Iammatteo, M., Alvarez Arango, S., Ferastraoaru, D., Akbar, N., Lee, A. Y., Cohen, H. W., & Jerschow, E.
Affiliations
  • Albert Einstein College of Medicine (US)
  • Montefiore Medical Center (US)
Corresponding author
Jerschow, Elina
ORCID
Venue
The Journal of Allergy and Clinical Immunology In Practice
Publisher
Elsevier BV
Published
2019-01
Volume
7
Issue
1
Pages
236-243
ISSN
2213-2198 (ISSN-L)
DOI
10.1016/j.jaip.2018.05.008
OpenAlex
W2803110430
Cited by
157
References
29
Citations by year
2026: 8 · 2025: 6 · 2024: 20 · 2023: 20 · 2022: 22 · 2021: 21 · 2020: 21 · 2019: 34 · 2018: 4
FWCI
12.98
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Journal of Allergy and Clinical Immunology In Practice (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Pharmacology › Drug-Induced Adverse Reactions
  • Health Sciences › Medicine › Immunology and Allergy › Food Allergy and Anaphylaxis Research
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords
penicillin allergy, amoxicillin, skin testing, drug allergy evaluation, drug tolerance, pediatric patients
MeSH terms
Administration, Oral, Aged, Allergens, Amoxicillin, Child, Drug Hypersensitivity, Female, Humans, Immunization, Male, Middle Aged, Placebos, Skin Tests, United States, Prevalence

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