FDA Panel Urges Changes to Antidepressant Labeling
'Black box' warning on suicide risk may be extended beyond children
THURSDAY, Dec. 14 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended Wednesday that "black-box" warnings on widely used antidepressants be changed, but the exact wording on the warning is still up in the air.
The issue at hand was whether current warnings on an increased risk for suicidal thoughts and behaviors in children and adolescents should be extended to young adults, or even older patients.
All eight members on the panel advocated some kind of change in labeling after a day-long meeting, according to an FDA press briefing held late Wednesday. But in the end, six members voted to extend the current suicide warning beyond children, but no exact age cut-off was specified.
"Opinions were mixed," said panel member Daniel Pine, M.D., chief of child and adolescent research at the National Institute of Mental Health.
Pine added that the FDA and the panel members agreed that "the level of detail in the data was such that it was not possible to give a precise age at which it was particularly concerning in terms of the association with suicidal thoughts or behavior, or not concerning."
There was no presentation or vote on the specific wording of such a warning, Pine said. Discussion on a more precise wording is set for the near future.