Risk of Postmarket Black Box Warnings in FDA Approved Monoclonal Antibodies

Abstract

Beta-lactams are a kind of antibiotics frequently used to treat infections. Many people with negative allergy tests for these betalactams are still labeled as allergic in their medical records. This research aims to estimate the actual allergy prevalence to these antibiotics. The rate between the quantity of practiced tests and the number of people who have been consequently delabeled as allergic is also to be studied. METHODS: From January to June 2019, in the HUVM Department of Allergy, 149 allergy tests were practiced (n5149) in patients ranging from 1 to 86 years old, in order to discard beta-lactams allergy. These were skin tests (with PPL, MDM, penicillin G, amoxycillin/clavulanate, cefuroxime, and the beta-lactam involved), as well as controlled exposure trials. The outcome was afterwards compared with the allergy records database in order to ponder the rate of patients who are still labeled as allergic to these antibiotics. RESULTS: The prevalence of allergic patients to beta-lactams was of 12.75%. Allergy was discarded in 84.56% of the cases. After this research, 40.47% of the latter were still labeled as allergic to beta-lactams, whereas 58.73% of them already had their medical record delabeled. CONCLUSIONS: Nearly half of the patients discarded as beta-lactams allergic are still labeled as such in their medical records. These data prove not only the convenience of practicing allergy tests on these patients, but also of delabeling their medical records according to the results obtained from the tests.