Mesalamine is an enteric-coated 5-aminosalicylic acid formulation effe
ctive in the treatment of ulcerative colitis, and in decreasing the re
lapse rate in Crohn's disease. However, little data are available rega
rding 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 mesal
amine were reviewed, representing >150 patient years of use. Among the
se, 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 disea
se, and thus mesalamine therapy was initiated earlier. When used as mo
notherapy, no difference was noted in the average dose used for the tr
eatment of active disease versus maintenance therapy (36 mg/kg/day). H
owever, the average dose used did increase since 1992, for both the tr
eatment of active disease and relapse prevention (43 mg/kg/day). Overa
ll, 18 patients (11.8%) were withdrawn from mesalamine therapy; howeve
r only 8 (5.2%) had objective side effects. Exacerbation of diarrhea w
as the most common reason for withdrawal. Although reported rarely, no
serious adverse reactions such as pancreatitis or hepatic or renal dy
sfunction 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.