TY - JOUR
T1 - Safety and Outcomes of Oral Graded Challenges to Amoxicillin without Prior Skin Testing
AU - Iammatteo, Melissa
AU - Alvarez Arango, Santiago
AU - Ferastraoaru, Denisa
AU - Akbar, Nadeem
AU - Lee, Andrew Y.
AU - Cohen, Hillel W.
AU - Jerschow, Elina
N1 - Publisher Copyright:
© 2019 American Academy of Allergy, Asthma & Immunology
PY - 2019/1
Y1 - 2019/1
N2 - 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.
AB - 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.
KW - Adverse drug reaction
KW - Drug provocation test
KW - Graded challenge
KW - Hypersensitivity reaction
KW - Penicillin allergy
KW - Placebo
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U2 - 10.1016/j.jaip.2018.05.008
DO - 10.1016/j.jaip.2018.05.008
M3 - Article
C2 - 29802906
AN - SCOPUS:85048994071
SN - 2213-2198
VL - 7
SP - 236
EP - 243
JO - Journal of Allergy and Clinical Immunology: In Practice
JF - Journal of Allergy and Clinical Immunology: In Practice
IS - 1
ER -