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Antidepressant MedGuide

Executive Summary

FDA's patient Medication Guide on antidepressants and pediatric suicidality will be available by the end of January, agency says. FDA releases 1proposed MedGuide Nov. 3 with language subject to negotiations with antidepressant drug sponsors; the agency hopes to finalize it by December. The MedGuide is one piece of FDA's plan to alert patients and prescribers to the antidepressant pediatric suicidality risk, which also includes a "black box" warning and unit-of-use packaging (2"The Pink Sheet" Oct. 26, 2004, p. 6). The proposed language generally follows FDA's antidepressant labeling changes, but does point to a potential relationship between antidepressants and violent behavior...

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