Pediatric direct oral challenges may be effective in delabeling penicillin allergies
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Key takeaways:
- Only two patients had a delayed reaction to a direct oral challenge.
- Regardless of risk category, 93 of the 96 patients who were administered a DOC were delabeled.
Hospitalized pediatric patients who were given direct oral challenges for penicillin allergies saw success in delabeling, according to a study published in The Journal of Allergy and Clinical Immunology: In Practice.
“The mere presence of a penicillin allergy label has been shown to increase the use of suboptimal antibiotics and increase resistance,” Katie M. Ray, PharmD, specialty pharmacy technician, Children’s Wisconsin Department of Quality and Health Outcomes, told Healio.
“Allergy label removal is common for many outpatient allergy settings, but there is less data describing outcomes in hospitalized children. We had noticed hesitation from many of our inpatient providers,” Ray continued.
Children with a low-risk penicillin allergy were recruited from Children’s Wisconsin, a pediatric medical center, from January 1, 2021, to June 27, 2023.
Families of the children were asked for verbal consent after which a single treatment dose of amoxicillin or amoxicillin-clavulanate was administered. They were then asked to stay for 1 hour to monitor the appearance of any immediate reactions.
Exclusion criteria included the use of any medications that could impact an allergic response, symptoms that also occur in allergic responses such as rash, vomiting or wheezing, and any children younger than 2 years of age or with a developmental delay.
A report was constructed to retrospectively analyze children that were admitted with a penicillin allergy and underwent a DOC. In order to identify delayed reactions, researchers captured data on the re-addition of an allergy up to 12 months after the DOC.
In total, 1,237 patients (median age, 11.76 years) were admitted to the center with a penicillin allergy label. Among them, 648 (86.7%) reported an amoxicillin or penicillin allergy and 121 (16.2%) reported an allergy to amoxicillin-clavulanate as the inciting agent.
The allergic reactions most commonly reported by patients were rash/hives (81.8%), itching (8.2%), and swelling (8.2%). Family history was reported by 23 patients as the reason for their allergy label, while 76 reported that their reactions were due to common side effects such as nausea diarrhea or vomiting.
Formal direct oral challenges (DOCs) were completed by 96 patients who were admitted to acute care. Among them, 10 were categorized as high risk, 64 as low risk and 22 with an unknown risk.
“Direct oral penicillin challenges are safe and effective in low risk hospitalized children,” Ray said. “Over 95% (93/96) of our inpatient population tolerated the oral challenge, with just one reported failure and two delayed reactions. These success rates are similar to the outpatient clinic setting, where 5% to 10% of patients are reported to have non-severe reactions.”
Ray further emphasized that these findings are especially important for hospitalized children who require penicillin as their optimal treatment, as this allows them a path to obtain this drug.
“One might presume the hospital is a challenging location to de-label children who do not need antibiotics during their visit, but we showed that direct oral challenges were feasible in this population as well,” she said.
The findings in this study further support DOCs in children and expand the settings in which they can take place.
”Penicillin allergy labels seem to be a culture, almost a mindset, that many patients and their families feel passionately about,” said Ray. “Healthcare providers seem to have a similar mindset acting in the mantra of ‘do no harm,’ without recognition that these actually do cause harm. Each description of success pushes healthcare and the general population towards stomping out these unnecessary labels. We are excited to build upon this literature and continue to describe our successes in children.”
Perspective
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These findings are helpful because there are limited data on pediatric inpatient challenges.
I agree with the aspect of the study that elective penicillin evaluations may feel like too much for families already dealing with a hospitalization, so I think this accounts for the overall low high refusal rate in the study. Challenging pediatric patients to amoxicillin when they are healthy outpatients is the best way to go. The challenge itself is not difficult. I just think it is another thing that may feel overwhelming to families who are already dealing with a hospitalized child.
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