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Worsening depression also a concern: suicidality warning added to antidepressant labels.(News)

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| August 15, 2004 | Mechcatie, Elizabeth | COPYRIGHT 2004 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

Warnings about the potential for suicidality and worsening of depression during treatment with antidepressants for major depressive disorder have begun to appear in the label of antidepressant drugs, in response to a request made by the Food and Drug Administration in March.

At press time, those changes had been made in the labels for venlafaxine (Effexor and Effexor XR), nefazodone (Serzone), bupropion (Wellbutrin, Zyban), citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), and paroxetine (Paxil).

The warnings, which apply to both adult and pediatric patients with major depressive disorder, recommend that patients be observed closely for clinical worsening and the emergence of suicidal ideation and behavior, particularly when they begin treatment and when the dose is changed.

The warnings also advise families and caregivers of such patients to be alert to ...

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