Comparing prescribing patterns for topical corticosteroids based on their FDA indication by age

Abstract

Atopic dermatitis (AD) affects up to 20% of the pediatric population, with a two-to threefold increase in prevalence over the past 30 years. 1 With this increase in the number of AD patients, including infants and young children, providers require safe and efficacious medications to successfully treat these pediatric patients. While TCS are commonly used as a first-line treatment for AD and prescribed in 59% of all AD visits, many are prescribed off-label. 2-4 This is not isolated to TCS, as an estimated 21% of all drugs are prescribed off-label in the United States, 5 with higher off-label use in pediatric populations (31%). 6 Adverse events such as pruritus, skin burning, folliculitis, and skin infection have occurred with the use of TCS in pediatric populations even when used within label indications and age range. 7-9 Offlabel usage of TCS can also lead to adverse events. The FDA-approved age range indications of available TCS treatments vary (Table 1). This study explores the frequency with which topical corticosteroids are prescribed for AD outside of their FDA-approved age range and indication.

Off-label medications in the treatment of hospitalized children with atopic dermatitis

“…Prescribing TCS off-label due to the age of the patients seems to be a common practice. In the USA topical desoximetasone was given off label to 52% of AD patients, followed by mometasone (30%) and betamethasone used in 18% [28]. Results regarding betamethasone are very similar to our cohort with age off-label prescriptions in 20.39%.…”

“…Ninety six medications (34.53%) were prescribed off-label in relation to the indication, with second-generation antihistamines being the most frequent ones (72), followed by antibiotics (15), corticosteroids (6), antivirals (2) and methotrexate (1). Second-generation H 1 receptor antagonists prescribed off-label were bilastine (28), cetirizine (28), levocetirizine (9), fexofenadine (3) rupatadine (3) and desloratadine (3).…”

“…Topical steroids (TCS) are the first-line treatment for AD exacerbation with minimal side effects and are used worldwide since mid-1950s [27]. It is estimated that TCS are prescribed in around of 60% doctors' appointments for AD [20,28]. Practically all TCS have indications specifically for atopic dermatitis or inflammatory dermatoses in SmPCs.…”