Mesalamine in pediatric inflammatory bowel disease: a 10-year experience.

: Mesalamine is an enteric-coated 5-aminosalicylic acid formulation effective in the treatment of ulcerative colitis, and in decreasing the relapse rate in Crohn's disease. However, little data are available regarding its use in children and adolescents. To determine the modalities of use, safety, and the optimal dose in this age group, charts of 153 pediatric patients with inflammatory bowel disease treated with mesalamine were reviewed, representing >150 patient years of use. Among these, more than half of the children diagnosed with Crohn's disease (120 patients) had ileocolonic involvement, and pancolitis predominated in those with ulcerative colitis (33 patients). Patients with ulcerative colitis were diagnosed at a younger age than those with Crohn's disease, and thus mesalamine therapy was initiated earlier. When used as monotherapy, no difference was noted in the average dose used for the treatment of active disease versus maintenance therapy (36 mg/kg/day). However, the average dose used did increase since 1992, for both the treatment of active disease and relapse prevention (43 mg/kg/ day). Overall, 18 patients (11.8%) were withdrawn from mesalamine therapy; however only 8 (5.2%) had objective side effects. Exacerbation of diarrhea was the most common reason for withdrawal. Although reported rarely, no serious adverse reactions such as pancreatitis or hepatic or renal dysfunction were observed. This study suggests that mesalamine is a safe and well-tolerated medication in the long-term treatment of pediatric patients with ulcerative colitis and Crohn's disease.