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Pediatric prescribing practices and the FDA Black-box warning on antidepressants
Amy Cheung1, Diane Sacks, Carolyn S Dewa
1Department of Psychiatry, University of Toronto, Toronto, Canada. amy.cheung@sunnybrook.ca
Insights
Pediatricians changed antidepressant prescribing after the FDA Black-box warning, with many increasing patient monitoring or stopping SSRI treatment. This study highlights shifts in clinical practice for youth depression management.
Area of Science:
- Pediatric medicine
- Psychiatry
- Clinical practice guidelines
Background:
- The 2004 FDA Black-box warning on antidepressants led to a 58% decrease in pediatric use.
- This decrease coincided with an increase in completed suicides among youth.
- No prior studies examined clinician-level practice changes post-warning.
Purpose of the Study:
- To investigate how pediatricians altered their clinical practices regarding antidepressant prescriptions following the FDA warning.
Main Methods:
- A national mail survey was distributed to 2395 practicing pediatricians in Canada.
- The survey assessed awareness of the FDA warning, practice changes, and reasons for prescribing modifications.
- Data were collected from 670 (38%) of 1748 eligible respondents.
Main Results:
- 72% of surveyed pediatricians were aware of the FDA warning.
- 80% of aware pediatricians modified their prescribing habits, with 32% increasing patient monitoring.
- 7% discontinued SSRI treatment for at least one patient; those observing worsening depression were more likely to do so.
Conclusions:
- This is the first national study detailing pediatrician practice changes concerning antidepressant use after the FDA warning.
- Further research is required to understand the motivations behind these changes.
- Developing strategies to help clinicians optimally integrate warnings into practice is crucial.
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).
Conclusion:
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.
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