Safety profile of an oral nasal decongestant/antihistamine combination in pediatrics: a real-world experience/ Perfil de segurança de uma combinação de descongestionante nasal e anti-histamínico em crianças: uma experiência de mundo real

Abstract

Objective The objective of this work is to characterize the safety profile of phenylephrine and brompheniramine in pediatric patients through the evaluation of post-marketing pharmacovigilance data. Method: Adverse events and situations grouped as medication errors, occurring in patients aged from zero to 12 years exposed to Decongex Plus received by the pharmacovigilance department of Aché Laboratórios Farmacêuticos during the period from 2/1/2014 to 9/30/2019 were included in this study. The events were grouped according to the age of the patients and classificated regard seriousness and expectedness. The data found were compared with other studies of the same gender and with international database. Results: A total of 1,391 adverse events occurred in patients aged between 0-12 years were included. The results showed a total incidence of adverse events of 0.0035% (rare according to local legislation). The majority (62.68%) occurred in the age group of 2 to 6 years of age. In this age group, 97.82% of the adverse events were considered non-serious, the majority being somnolence, and only 2.18% of the events were considered serious. In children over 7 years of age (8.62% of the total), it was also found that most adverse events (94.16%) were non-serious. The age group under two years of age totaled 28.68% of the adverse events received, with 98% being considered non-serious (main event was also somnolence) and 67% being medication errors. Conclusions: The study points to a favorable safety profile of phenylephrine and brompheniramine in pediatric patients. Randomized, controlled clinical studies are warranted to confirm these findings.