Health

FDA issues antidepressant alerts

NEWS IN BRIEF — Posted July 19, 2004

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The Food and Drug Administration is continuing to urge physicians to closely monitor adult and child patients taking antidepressants.

Label changes recommending heightened vigilance have already been made by the manufacturers of Wellbutrin, or bupropion hydrochloride, also marketed as Zyban; Paxil, or paroxetine hydrochloride; and Serzone, nefazodone hydrochloride. Labeling changes were also under consideration for other antidepressants, according to GlaxoSmithKline, the manufacturer of Paxil.

Patients should be watched for signs that their depression is worsening or that they have thoughts of suicide, particularly when they begin taking the drugs or anytime there is a dosage increase or decrease.

The agency posted the warnings on the agency's MedWatch Web site. The changes spring from the FDA's ongoing review of possible safety issues in antidepressant use by children.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2004/07/19/hlbf0719.htm.

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