FDA Issues Advisory on Antidepressants for Teenagers, Children

The FDA on Monday issued a public health advisory that asks physicians to prescribe antidepressants to teenagers and children "with caution" because of a potential for increased suicide risk, the Baltimore Sun reports (Bell, Baltimore Sun, 10/28). In addition, the FDA released a second advisory to remind physicians that Prozac, manufactured by Pfizer, is the only antidepressant approved to treat depression in children (Harris, New York Times, 10/28). The FDA issued the advisories after a preliminary review of the results of 20 clinical trials that involved more that 4,100 patients found that participants who took several antidepressants appeared more likely to consider or attempt suicide than those who received placebos. However, the FDA said that "it's unclear whether results could be explained by study bias" or other factors and asked that parents continue antidepressant treatment for their children until they discuss the issue with a physician, the Sun reports (Baltimore Sun, 10/28). Thomas Laughren, the FDA team leader for psychiatric medications, said, "We're not saying these drugs can't be used. ... We're saying one should proceed with caution" (Kaufman, Washington Post, 10/28). The language used in the advisories issued Monday represented a "softening" of an FDA advisory in June that physicians "avoid giving young patients" antidepressants, the Sun reports (Baltimore Sun, 10/28). The FDA issued the June advisory based on results from a study of the antidepressant Paxil, manufactured by GlaxoSmithKline, that found children who received the medication were more likely to attempt suicide that those who received a placebo and that the treatment did not improve symptoms of depression in children.

The FDA on Feb. 2 plans to convene a committee to examine whether physicians should prescribe antidepressants to teens and children, whether the agency should require revised warning labels for the medications and what studies researchers should conduct to examine the potential link between antidepressant use and an increased risk of suicide in teens and children. An FDA advisory committee in 1991 examined the potential link between antidepressants and suicide in adults and decided that "there was no compelling evidence" of such a link, but seven of the 10 members of committee have said that based on the results of the Paxil study, they would "consider changing their votes," the Times reports (New York Times, 10/28). David Schaffer, chief of child and adolescent psychiatry at Columbia University, said, "I think the FDA needs to be cautious about attributing particular adverse effects to a potentially helpful medication for the general public" (Washington Post, 10/28). NPR's "Morning Edition" on Tuesday reported on FDA plans to examine the potential link between antidepressant use and an increased risk of suicide in teens and children (Que, "Morning Edition," NPR, 10/28). The full segment is available online in RealPlayer.