ANTIDEPRESSANT MAY GET EXPANDED WARNING LABELS

Pharmacy Times, Volume 0, 0

A federal advisory panelhas recommended that theFDA update black box warningson antidepressants toinclude an increased risk ofsuicide for adults under 25.The drugs have included ablack box warning about theincreased risk of suicidalthoughts and actions in childrenand adolescents since2004.

The panel also advised the agency to add language tothe black box warning highlighting the dangers ofuntreated depression. Thomas Laughren, MD, director ofthe FDA's division of psychiatry products, said theagency is leaning toward expanding the black box warningto include young adults. Officials also said they willtry to use language to encourage health care practitionersto prescribe the drugs carefully. The FDA is in a difficultposition, because it does not want the warning tolead physicians to stop prescribing the medications.