Luvox was approved by the FDA in 1997 for the treatment of obsessive-compulsive disorders (OCD) in children, but not for the treatment of depression. Indeed, no antidepressant -- Prozac, Zoloft, Paxil or Luvox -- has been approved for pediatric use. Solvay, Luvox' manufacturer, declares it "safe and effective.'' Yet the Physicians' Desk Reference reports that during controlled clinical trials manic reactions developed in 4 percent of children on Luvox. Another clinical trial found that Prozac caused mania in 6 percent of the children studied.
FDA is asking 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 medications under review include bupropion, citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, escitalopram and venlafaxine. It should be noted that the only medication that has received approval for use in children with major depressive disorder is fluoxetine (Prozac). Quite a few of these drugs are approved for the treatment of obsessive-compulsive disorder in pediatric patients, i.e., sertraline (Zoloft), fluoxetine (Prozac), and fluvoxamine (Luvox). Luvox is not approved as an antidepressant in the United States.
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