Panel Weighs Antidepressant Risks for Kids

A U.S. advisory panel began meeting Monday to debate whether certain antidepressants should come with stronger warnings about the chances of suicidal behavior in children and teens who take the drugs.

Regulators say data on the risks are murky, and they are looking to the panel of outside medical experts to help make sense of findings from 23 clinical trials of nine different drugs. U.S. Food and Drug Administration officials said they are being careful because they do not want to unnecessarily discourage doctors from prescribing the drugs for depression, a serious mental illness that itself raises suicide risk. “A mistake of either kind could, in our view, have disastrous consequences,” Dr. Russell Katz, the FDA’s director of neuropharmacological drugs, told the panel. The two-day meeting is due to close Tuesday with discussion and votes by the advisers on their recommendations to the FDA. The controversy erupted last year after British authorities told doctors to avoid prescribing most antidepressants to children because of worries about links to suicidal behavior. The FDA declined to go that far and has come under fire as being too slow to recognize the potential hazards. The FDA first became aware of a possible link to suicide in May 2003, Katz said. The agency now advises doctors and parents to watch for signs of worsening depression or suicidal thoughts in patients taking the newer antidepressants. Most of the drugs in question are in a class called selective serotonin reuptake inhibitors, or SSRIs. Most, however, have not been shown to work for children. Only Eli Lilly and Co.’s Prozac, also sold generically as fluoxetine, is approved for treating pediatric depression. The advisory panel will examine new analyzes from the FDA and Columbia University of reports of suicidal thoughts and actions in clinical trials done from 1983 to 2001. Children studied were as young as six. FDA reviewer Dr. Tarek Hammad recently concluded that youth who took antidepressants during the studies were 1.78 times more likely to report suicidal behavior than others who took a placebo. No actual suicides occurred during any of the trials. The likelihood of suicidal actions varied widely among the drugs, Hammad said in a written review. The data had several limitations, however. When looked at separately, none of the trials showed a significantly higher risk, Hammad said. Another FDA reviewer, Dr. Andrew Mosholder, concluded early this year that the medicines made children and adolescents suicide-prone. His supervisors disagreed and did not let him present his views at an advisory panel meeting in February. Mosholder is one of several FDA officials scheduled to speak to the panel later on Monday. Parents of children who killed themselves while on antidepressant therapy also are expected to give testimony.(Source: Reuters Health News: Lisa Richwine: September 2004.)