Budesonide Use in Children and Adolescents With Crohn's Disease

Marcia L. Buck, PharmD, FCCP, FPPAG, BCPPS


Pediatr Pharm. 2016;22(11) 

In This Article

Abstract and Introduction


On April 29, 2016, the Food and Drug Administration extended the approval of controlled ileal release budesonide (Entocort® EC) to include the treatment of mild to moderate active Crohn's disease in the ileum and/or ascending colon in children 8 years of age and older.[1,2] Corticosteroids have long been recommended for inducing remission in children with active Crohn's disease.[3] Controlled ileal release budesonide, first approved by the FDA in 2001, produces less systemic corticosteroid exposure than prednisolone and may reduce the incidence of adverse effects. Use of budesonide in children result in less reduction in growth velocity than prednisone. In the 2014 European Crohn's and Colitis Organization and the European Society of Pediatric Gastroenterology, Hepatology, and Nutrition (ECCO/ESPGHAN) consensus guidelines on the management of Crohn's disease, 96% of the experts on the panel agreed that budesonide may be used as an alternative to systemic corticosteroids for children with ileal or ascending colonic disease.[4]