Pediatric antidepressant use after the black-box warning.
In 2004 the Food and Drug Administration (FDA) required a black-box warning on antidepressants that describes a possible suicide risk in children. An analysis of the events, evidence, and FDA actions reveals information asymmetries that affect various players' ability to identify and act on risks. Antidepressant use declined sharply overall, not just among children, and the FDA's emphasis on the proven efficacy of fluoxetine (generic Prozac) did not prompt dramatic shifts in prescribing. We conclude that risk communication strategies need to be refined, to ensure intended results.
Department of Health Policy at Yale Medical School in New Haven, Connecticut, USA. susan.busch@yale.edu
Susan H
SH
Busch
Colleen L
CL
Barry
D000293:Adolescent; D000928:Antidepressive Agents / Q000009:adverse effects; D002648:Child; D003866:Depressive Disorder / Q000188:drug therapy*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D017723:Drug Utilization Review; D019317:Evidence-Based Medicine / Q000331:legislation & jurisprudence; D006801:Humans; D018570:Risk Assessment; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects; D013405:Suicide / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*; D000092864:Suicide Prevention
D000928:Antidepressive Agents; D017367:Selective Serotonin Reuptake Inhibitors