FDA advisory on antidepressants

FDA advisory on antidepressants

Carrie Morantz

The U.S. Food and Drug Administration (FDA) has issued a Public Health Advisory that provides further cautions to physicians, their patients, and families and caregivers of patients about the need to closely monitor adults and children with depression, especially at the beginning of pharmacotherapy, or when the doses of antidepressants are changed with an increase or decrease in the dose. The Public Health Advisory containing new label warnings and cautions is available online at: http://www.fda. gov/cder/drug/antidepressants/ default.htm.

The FDA has been closely reviewing the results of antidepressant studies in children 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 thoughts and actions in the children given antidepressants. There were no suicides reported in any of the trials. 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.

The FDA has initiated a full review of these reported behaviors by experts in such evaluation. However, it is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior. The agency is advising physicians, patients, families, and caregivers of adults and children that they should closely monitor all patients being placed on therapy with these drugs for worsening depression and suicidal thinking, which can occur during the early period of treatment. The agency also is advising that these 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, akathisia (severe restlessness), hypomania, and mania, and that physicians be particularly vigilant of patients who may have bipolar disorder.

The drugs under review include bupropion (Wellbutrin), citalopram (Celexa), fluoxetine (Prozac), fluvoxamine (Luvox), mirtazapine (Remeron), nefazodone (Serzone), paroxetine (Paxil), sertraline (Zoloft), escitalopram (Lexapro), and venlafaxine (Effexor). The only drug that has received approval for use in children with major depressive disorder is fluoxetine. Several of these drugs are approved for the treatment of obsessive-compulsive disorder in pediatric patients (i.e., sertraline, fluoxetine, and fluvoxamine). Fluvoxamine is not approved as an antidepressant in the United States.

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