March 6 (Bloomberg) -- Antidepressants appear to double the
risk of suicidal thoughts and actions in children who take them, U.S.
regulators said in a study outlining the methodology used for a 2004 report that led to warnings on drugs including Eli Lilly & Co.'s Prozac and GlaxoSmithKline Plc's Paxil.

The Food and Drug Administration first presented the
findings, detailed today in the Archives of General Psychiatry, to an advisory panel in September 2004. The agency followed the next month with a requirement that makers of antidepressants warn patients and doctors with a notice in prescribing information highlighted with a so-called black box.

The warning led to a 20 percent drop in antidepressant
prescriptions for children between March 2004 and June 2005, according to Psychiatric News, the newspaper of the American Psychiatric Association, which cited NDC Health Inc., an Atlanta- based prescription-tracking service. The FDA study examined data from 24 clinical trials of nine antidepressants involving 4,582 children and adolescents. No suicides occurred in the trials.

In addition to Prozac and Paxil, the trials examined Glaxo's Wellbutrin, Pfizer Inc.'s Zoloft, Wyeth's Effexor, Bristol-Myers Squibb Co.'s Serzone, Forest Laboratories Inc.'s Celexa, Akzo Nobel NV's Remeron and Solvay SA's Luvox.

The analysis of findings from all the studies found that, overall, about 4
percent of children taking the drugs thought about or attempted suicide,
compared with 2 percent of those taking a placebo. The degree of risk varied from trial to trial.

The FDA announced last July that it was assessing whether
antidepressants also increase the risk of suicidal thinking or actions
among adults. The agency plans to release data from that review about
midyear, said Thomas Laughren, director of the division of neuropharmacological drug products.

To contact the reporter on this story:
Rob Waters in San Francisco at  Rwaters5@bloomberg.net.