8
Adverse Events 1992-2003:
General
Overview (raw counts)
•Total: over 17,000 adult and pediatric reports (68
% domestic)
•< 5 %
of total are pediatric
•Top 20
pediatric AEs
–similar to
those reported in adults
–majority
labeled
–unlabeled
events related to maternal exposure
•Number of pediatric
adverse event reports increased in 2002 compared with prior years