Pediatric prescribing practices and the FDA Black-box warning on antidepressants.
BACKGROUND
Since the FDA Black box warning in 2004, there has been a 58% drop in antidepressant use among children and adolescents with depression. Paralleling this decrease is an associated increase in completed suicides in youth. To date, no study has examined, on a clinician level, the changes in practice that have occurred subsequent to the FDA warning.


OBJECTIVE
To examine changes in pediatrician clinical practice resulting from the FDA warning on antidepressants.


METHODS
Subjects were recruited through a national program sponsored by the Canadian Pediatric Society that regularly surveys practicing pediatricians. The mail survey inquired about knowledge of the Black-box warning, whether their practice changed and reasons for changes in prescribing practices with antidepressants after the warning. We surveyed a total of 2395 pediatricians in Canada.


RESULTS
Of the 1748 eligible pediatricians, 670 (38%) responded.Seventy-two percent (n = 484) of respondents were aware of the FDA warning. Of the 484 respondents who were aware of the warning, 80% (n = 386) changed their prescribing practices including 32% (n = 154) who followed their patients more closely. Seven percent (n = 35) stopped treatment with SSRIs in at least one patient. Physicians who had observed worsening depression/suicidality were more likely to discontinue treatment with SSRI's compared to those who had not observed these side effects previously (25% versus 6%, p < 0.001).


CONCLUSIONS
This is the first national study to examine individual pediatrician practice changes in antidepressant use subsequent to the FDA warning. Further research is needed to better understand the reasons for these changes to aid in the development of strategies that could help clinicians to optimally integrate these warnings into clinical practice.
Department of Psychiatry, University of Toronto, Toronto, Canada. amy.cheung@sunnybrook.ca
Amy
A
Cheung
Diane
D
Sacks
Carolyn S
CS
Dewa
Jessica
J
Pong
Anthony
A
Levitt
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects* / Q000627:therapeutic use; D002170:Canada; D002423:Cause of Death; D002648:Child; D003430:Cross-Sectional Studies; D003866:Depressive Disorder / Q000188:drug therapy* / Q000401:mortality; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D004363:Drug Utilization / Q000706:statistics & numerical data; D005260:Female; D019983:Guideline Adherence / Q000706:statistics & numerical data; D006306:Health Surveys; D006801:Humans; D008297:Male; D010372:Pediatrics / Q000706:statistics & numerical data*; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D013405:Suicide / Q000706:statistics & numerical data; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*; D000092864:Suicide Prevention
D018687:Antidepressive Agents, Second-Generation; D017367:Selective Serotonin Reuptake Inhibitors