An advisory panel to the Food and Drug Administration voted 15-8 on Tuesday to encourage stronger warnings on the use of antidepressants by children and teenagers.
The panel said the so-called "black box" warning should inform physicians that children who use antidepressants are more likely to become suicidal. The panel also voted unanimously to require drug manufacturers to include a patients' guide the explains the increased risk.
The FDA concluded two days of testimony on antidepressant use and suicide among young people. Studies show that 2 to 3 percent of children and teenagers who used the drug will exhibit suicidal behavior or thoughts unrelated to their underlying depression.
Get the Story:
Child Antidepressant Warning Is Urged
(The Washington Post 9/15)
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F.D.A. Panel Urges Stronger Warning on Antidepressants
(The New York Times 9/15)
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Relevant Documents:
Joint
Meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric
Advisory Committee (FDA)
Relevant Links:
Food and Drug Administration - http://www.fda.gov
Related Stories:
FDA links antidepressants to suicide in children
(9/14)
Study links
antidepressants to suicide in children (08/10)
Panel seeks stronger warning on antidepressant use
Wednesday, September 15, 2004
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