Worldwide safety experience with ceftibuten pediatric suspension

Ceftibuten suspension was administered to 1312 pediatric patients in clinicaltrials at a dosage of 9 mg/kg once daily, with a maximal daily dose of 400 mg. Adverse experiences were collected by voluntary reports by physicians from direct observations, parental and/or patient complaints in 1152 patients. In 160 patients gastrointestinal adverse experiences were elicited at each visit in addition to voluntary reports. Patients had a mean age of 4.9 years, the male: female ratio was 1:1 and 72% were white. Fifty-five percent (719 of 1312) of patients were treated in otitis media studies, 33% (438 of 1312) were treated in a pharyngitis study and 12% (155 of 1312) were treated in other studies. Adverse experiences occurred in 10% (138 of 1312) of all patients receiving ceftibuten suspension. The most common voluntarily reported treatment-related adverse events were diarrhea 3% (34 of 1152) andvomiting 2% (22 of 1152). For elicited adverse events related to treatment, the mostcommon were also diarrhea 9% (14 of 160) and vomiting 3% (5 of 160). There were no deaths and only 0.9% (12 of 1312) patients discontinued treatment because of adverse events. Abnormal laboratory values related to therapy were uncommon and no patient discontinued treatment because of abnormal laboratory values. No cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, serum sickness-like reactions orpseudomembranous colitis have been observed with ceftibuten suspension in research studies to date. Serious adverse events have not been observed in clinical trialsand sideeffects have been mild and transient. These data show that in a worldwide experience of 1312 pediatric patients, ceftibuten is well-tolerated in children with avariety of infections.