Evolving Management of Eosinophilic Esophagitis: From Diagnosis to Early Intervention - Episode 8
Safety Profile of Budesonide Oral Suspension
Panelists discuss how budesonide oral suspension demonstrates a favorable safety profile with transient adverse events similar to placebo rates and minimal risk of adrenal suppression when used alone. It has the advantage of being FDA-approved specifically for esophageal delivery rather than repurposing lung medications, which eliminates variability in homemade formulations and ensures consistent drug delivery to the esophagus.
The safety profile of budesonide oral suspension addresses common concerns about steroid therapy, particularly in pediatric populations where growth and development are primary considerations. Clinical experience with topical steroids for eosinophilic esophagitis (EoE) has generally demonstrated safety, with study data showing approximately 5% of patients experiencing cortisol suppression, but only in those concurrently using multiple steroid formulations (inhaled or topical). The literature shows variable rates of adrenal insufficiency ranging from 15% to 65%, though these studies differ significantly in methodology and assessment criteria, making direct comparisons challenging.
The phase 3 trial safety data revealed that 61% of patients in both treatment and placebo groups experienced transient adverse events, including common infections such as nasopharyngitis and sinusitis. Esophageal candidiasis and oral thrush occurred in some patients, though interestingly, cases were also observed in the placebo group, questioning direct causation. Serious adverse events occurred in 1% to 2% of patients and included conditions such as gastroenteritis, sepsis, and ovarian cysts that were not attributed to the medication itself. These safety findings support the medication’s tolerability profile in adolescents and adults aged 11 and above.
A significant advantage of FDA-approved budesonide oral suspension lies in its purpose-built design for esophageal delivery, contrasting with previous approaches that repurposed lung-targeted medications. This eliminates the variability inherent in “homebrew” formulations where families created inconsistent preparations with varying viscosity and delivery characteristics. Previously, treatment response assessment was complicated by uncertainty about whether adequate esophageal coating was achieved. Parents often express surprise when informed that growth may actually improve with treatment, as better swallowing and eating capabilities enhance nutritional intake. This represents a paradigm shift from traditional steroid concerns, supported by clinical data demonstrating that improved nutrition from effective EoE treatment outweighs potential steroid-related growth effects.
