Pediatric antidepressant use debated; new warnings issued.(Special Report From Washington on FDA Hearing)

The paucity of reliable research data was an important part of the discussion when the Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committees (PDAC/PAC) met in Washington in mid-September. At that meeting, the Committees voted 15 to 8 in favor of a "black box" warning on antidepressants with regard to their use in the pediatric population.

The call for the black-box warning came after the FDA ordered pharmaceutical companies to submit details of all their studies of antidepressants in children and adolescents. Because language used to describe events varied from study to study and could not be accurately compared, the FDA hired a group of suicide experts, led by Kelly Posner, Ph.D., of Columbia University, to standardize the language and reclassify the data into appropriate categories (see box, page 7). The 24 clinical trials dated back as far as 1983 and covered five conditions: 16 major depressive disorder (MDD), four obsessive compulsive disorder (OCD), two generalized anxiety disorder (GAD), one seasonal affective disorder (SAD) and one attention-deficit/hyperactivity disorder (ADHD).

The results suggest that of every 100 patients, two or three would be at risk for increased suicidality, twice the rate of those on placebo. The nine antidepressants reviewed were Prozac (fluoxetine), Zoloft (sertraline), Remeron (mirtazepine), Paxil (paroxetine), Effexor (venlafaxine), Celexa (citalopram), Wellbutrin (bupropion), Luvox (fluvoxamine) and Serzone (nefazodone). Prozac is the only FDA-approved drug for the treatment of depression in children and adolescents.

While the FDA is not obligated to act on the Committees' recommendations the agency usually follows the advice of their scientific advisors. On Sept. 16, following the meetings, the FDA issued a statement saying it "generally supports" the recommendations made by the Committees.

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