Worldwide safety experience with ceftibuten pediatric suspension.

Ceftibuten suspension was administered to 1312 pediatric patients in clinical trials 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) and vomiting 2% (22 of 1152). For elicited adverse events related to treatment, the most common 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 or pseudomembranous colitis have been observed with ceftibuten suspension in research studies to date.(ABSTRACT TRUNCATED AT 250 WORDS)