Health
FDA broadens antidepressant warnings
NEWS IN BRIEF — Posted April 12, 2004
The Food and Drug Administration has broadened its warnings on antidepressants to include adults as well as children and teens among those who must be carefully monitored for worsening depression and suicidal thoughts.
Patients should be watched especially closely at the beginning of therapy with any one of several antidepressants and when the dose is either increased or decreased, said the March 22 FDA public health advisory.
The drugs that are the focus of the new warning include Prozac, (fluoxetine); Zoloft (sertraline); Paxil (paroxetine); Luvox (fluvoxamine); Celexa (citalopram); Lexapro (escitalopram); Wellbutrin (bupropion); Effexor (venlafaxine); Serzone (nefazodone) and Remeron (mirtazapine).
Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric, according to the FDA.
If any such symptoms should worsen or newly emerge, the FDA recommends reevaluating the use of the medication. If a decision is made to stop treatment, the FDA recommends that the medication be tapered off rather than stopped abruptly.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2004/04/12/hlbf0412.htm.
