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6/23/2004

GSK Antidepressants Carry Suicide Warning

Kate Traynor

GlaxoSmithKline's paroxetine and bupropion hydrochloride antidepressants are the first of a group of 10 drugs to incorporate labeling changes requested this spring by the Food and Drug Administration (FDA), according to announcements yesterday from FDA's MedWatch program.

Two "Dear Healthcare Professional" letters from GlaxoSmithKline describe labeling changes warning that adults and children with major depression can suffer a worsening of the condition and may have suicidal thoughts or behaviors whether or not the depression is treated with medication.

GlaxoSmithKline has added the warning to its Wellbutrin and Paxil product lines. The company also added the warning to the labeling for Zyban, a bupropion product that is indicated for smoking cessation.

The revised labeling language states that therapy may need to be changed or stopped when troubling symptoms are "severe, abrupt in onset, or were not part of the patient's presenting symptoms."

FDA in March urged manufacturers to revise the labeling for fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram, bupropion, venlafaxine, nefazodone, and mirtazapine to incorporate language about the suicide risk in patients with major depression. The agency warned that patients should be observed carefully, especially when treatment begins or a dosage is changed, for signs of worsening depression.

FDA has not yet concluded that any of the 10 antidepressant drugs are directly responsible for increased suicidal thoughts or actions or a worsening of depressive symptoms. The regulatory agency stated that it is reviewing clinical data and will update its recommendations later this summer.