ANTIDEPRESSANT MAY GET EXPANDED WARNING LABELS

FEBRUARY 01, 2007

A federal advisory panel has recommended that the FDA update black box warnings on antidepressants to include an increased risk of suicide for adults under 25. The drugs have included a black box warning about the increased risk of suicidal thoughts and actions in children and adolescents since 2004.

The panel also advised the agency to add language to the black box warning highlighting the dangers of untreated depression. Thomas Laughren, MD, director of the FDA's division of psychiatry products, said the agency is leaning toward expanding the black box warning to include young adults. Officials also said they will try to use language to encourage health care practitioners to prescribe the drugs carefully. The FDA is in a difficult position, because it does not want the warning to lead physicians to stop prescribing the medications.




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