(A32) Utilization of beta-blockers among the pediatric population in the United States: a study in the FDA’s Sentinel System from 2008 to 2022

Publication Number: 315

Background: Beta-blockers are only approved for two pediatric indications in the United States (i.e., hypertension and hemangioma), but are commonly used for a variety of off-label conditions. Little is known about the magnitude and patterns of their use in the pediatric population.

Objectives: To examine utilization patterns of beta-blockers among the pediatric population in the United States.

Methods: Individuals aged 0 to 17 years were identified in the FDA’s Sentinel System from Jan 2008 to May 2022. We estimated annual prevalence of beta-blocker treatment. Characteristics of beta-blocker treatment episodes were determined during a 90-day window before treatment initiation (defined as no dispensing in the prior 6 months, or no dispensing since birth for infants under six months of age). Treatment duration was determined by allowing a grace period of 50% of previous days’ supply.

Results: Among 89.7 million eligible children, we identified 279,039 beta-blocker users. The annual prevalence of use increased from 1.24 per 1,000 children in 2008 to 2.04 per 1,000 children in 2021 (prevalence ratio: 1.65), which was driven by a substantial increase in the 0-1 year group (prevalence ratio: 5.44) and a moderate increase in the 13-17 year group (prevalence ratio: 1.61). The majority of users were females (60.5%) and those aged 13-17 years (64.4%), followed by 6-12 years (19.3%), 0-1 year (13.4%), and 2-5 years (3.0%). Propranolol accounted for the majority of use (68.8%), followed by atenolol (14.3%) and metoprolol (8.5%). In the 0-1 year group, hemangioma (52.5%) was present in more than half of treatment episodes, followed by congenital heart disease (36.3%) and cardiac arrhythmia (30.1%). In the 2-5 year group, the most common comorbidities were cardiac arrhythmias (32.9%), followed by congenital health disease (20.5%) and hypertension (11.5%). In the 6-12 year group, migraine (26.3%) was the most common comorbidity, followed by cardiac arrhythmias (17.3%) and anxiety disorder (14.8%). In the 13-17 year group, anxiety disorder was most common (29.2%), followed by migraine (24.7%) and cardiac arrhythmias (17.3%). The proportions of treatment episodes that lasted for more than 90 days were 61.0%, 42.6%, 31.1%, and 24.4% for the age groups 0-1 years, 2-5 years, 6-12 years, and 13-17 years, respectively.

Conclusions: Beta-blockers were used for a variety of cardiac and non-cardiac conditions in the pediatric population, and characteristics and durations of use differed significantly between age groups. In recent years, there was a notable increase in their use among the 0-1 year group. More evidence is needed to support the efficacy and safety of beta-blocker use in the pediatric population.