Ø
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ØFOOD AND DRUG ADMINISTRATION
(FDA)
ØCenter for Drug Evaluation and
Research (CDER)
ØPSYCHOPHARMACOLOGIC DRUGS ADVISORY
COMMITTEE
ØCharge to the Committee
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Ø Please discuss the findings from FDA’s meta-analysis on antidepressants and suicidality in adult patients
and comment both on the
findings and on our general plans for labeling changes to reflect this new
information. We would also encourage you to discuss possible research
strategies to better
understand the apparent risk of suicidality
with antidepressant use in younger patients.