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Paxil (paroxetine hydrochloride) - Jun 22, 2004

Audience: Neuropsychiatric healthcare professionals

FDA and GlaxoSmithKline notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of labeling to alert healthcare professionals that patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications. The warning recommends patients being treated with antidepressants be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.

[May 2004 Letter - GlaxoSmithKline]
[April 2004 Paxil Revised Label - GlaxoSmithKline]
[April 2004 Paxil CR Revised Label - GlaxoSmithKline]