Wellbutrin (bupropion hydrochloride)
June 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 Wellbutrin XL Revised Label - GlaxoSmithKline]
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