•FDA had reviewed safety and efficacy data from 8 pediatric programs for antidepressants over roughly 3 year period
•Adverse events, including those suggestive of possible suicidality, coded by sponsors using approaches unique to each program
•Suicidality did not emerge as a matter for concern based
on these reviews
•Paxil review did raise a question of data management, in
that events suggestive of possible
suicidality were subsumed,
along with other events, under preferred term “emotional lability”
•Finding led to request to GSK to separate out verbatim terms suggestive of suicidality