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E-News from Washington Vol. 04-06 March 26, 2004
FDA Issues Advisory on Use of Antidepressants in Adults and Children

The Food and Drug Administration, on March 22, issued a Public Health Advisory that provides further cautions to physicians, clinicians, their patients, families and caregivers about the need to closely monitor both adults and children with depression, especially in the beginning of treatment, or when the doses are changed with either an increase or decrease in the dose. The FDA has initiated a full review of these reported behaviors by experts in such evaluations. However, it is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior. 

FDA has been closely reviewing the results of antidepressant studies, since June 2003, after an initial report on studies with paroxetine (Paxil), and subsequent reports on studies of other drugs, appeared to suggest an increased risk of suicidal thinking and actions in the children given antidepressants. On close examination of the initial reports, it was unclear whether certain behaviors reported in these studies represented actual suicide attempts, or other self-injurious behavior that was not suicide-related. There were no suicides in any of the trials.

The advisory recommends patients be observed for certain behaviors that are known to be associated with these drugs, such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, restlessness, hypomania and mania, and that physicians be particularly vigilant in patients who may have bipolar disorder. 

FDA is asking drug manufacturers to change the labels of ten drugs to include stronger cautions and warnings about the need to monitor patients for the worsening of depression and the emergence of suicidal ideation, regardless of the cause of such worsening. The drugs under review include Wellbutrin, Celexa, Prozac, Luvox, Remeron, Serzone, Paxil, Zoloft, Lexapro, and Effexor.

The interim actions taken by the FDA follow recommendations made by the Agency’s Psychopharmacologic Drugs and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee, which met on February 4, 2004. The advisory committee members advised FDA that the labeling should draw more attention to the need to monitor patients being treated with certain antidepressants. 

Beth Powell
Director, Public Policy and Professional Issues
American Mental Health Counselors Association
801 N. Fairfax Street, Suite 304
Alexandria, Virginia 22314
Phone: 800-326-2642, ext. 105
Phone: 703-548-6002, ext. 105
Fax: 703-548-4775
Website: www.amhca.org