32
Pediatric Adverse Events in the
One-Year Post-exclusivity Period
One-Year Post-exclusivity Period
•Total
unduplicated reports (n=42)
•16
in utero exposures; resulted in
unlabeled events and one death
•26
children involving direct exposure, 8 unlabeled events, no
deaths
–16
serious AEs (10 hospitalization, 4 life-threatening, 2 with
disability)
–dose
5-60 mg/day, median dose 20 mg/day