ETHESDA, Md., Sept. 13 - Top officials of the Food and Drug Administration acknowledged for the first time on Monday that antidepressants appeared to lead some children and teenagers to become suicidal.

Dr. Robert Temple, director of the F.D.A.'s office of medical policy, said after an emotional public hearing here that analyses of 15 clinical trials, some of which were hidden for years from the public by the drug companies that sponsored them, showed a consistent link with suicidal behavior.

"I think that we now all believe that there is an increase in suicidal thinking and action that is consistent across all the drugs,'' Dr. Temple said, summarizing the agency's presentation to a special advisory committee. "This looks like it's a true bill.''

The acknowledgement, made after the hearing, comes a year after the agency suppressed the conclusions of its own drug-safety analyst, Dr. Andrew Mosholder, who first found a link between the drugs and suicide in teenagers and children. Agency officials wrote in internal memorandums that Dr. Mosholder's analysis was unreliable, and they hired researchers at Columbia University to re-analyze the same data. That study recently reached conclusions nearly identical to Dr. Mosholder's.

The testimony came before an advisory committee of 31 independent experts that the F.D.A. has charged with making a recommendation about the labeling and use of antidepressants in children and teenagers.

Family members of suicide victims at the hearing angrily denounced agency officials for the delay in admitting the risk of antidepressants in children. The British health authorities decided in December to ban the use of most antidepressants in children and teenagers.

Mathy Milling Downing of Laytonsville, Md., whose 12-year-old daughter hanged herself in January, said: "Candace's death was entirely avoidable had we been given the appropriate warnings. "The blood of these children is on your hands.''

Agency officials said that they had no regrets about the months of study. "I don't think the data were at that time reliable,'' Dr. Temple said. "Scaring people needlessly" or overdoing a warning is worrisome, he added.

The most popular pills are Zoloft, made by Pfizer; Paxil, made by GlaxoSmithKline; and Prozac, made by Eli Lilly & Company. In 2002, nearly 11 million children and teenagers were prescribed antidepressants.

The risk of suicide among patients given the pills is very small. If 100 children and teenagers are given antidepressants, 2 or 3 will become suicidal who otherwise would not have had they been given placebos, agency officials said. None of the children in the trials committed suicide, but some thought about or attempted suicide, researchers found.

In March, the agency required antidepressant manufacturers to include on labels a warning that therapy with antidepressants could lead some patients, both adults and children, to become suicidal. The committee must decide whether this warning is strong enough or whether the drugs should be banned for children. The advisory committee is expected to make a decision on Tuesday. The F.D.A. normally follows recommendations of its advisory committees.

It is a complex task. Most studies of the drugs have failed to show that they have any effect on depression in children and teenagers. But the drugs have proven effective in adults, and studies suggest that teenage suicide rates have dropped in countries where use of antidepressants is widespread. A large study of depressed teenagers conducted by the National Institute of Mental Health recently found that Prozac was far more effective in treating depression in children and teenagers than was talk therapy.

Several speakers noted that clinicians would have almost nothing to offer depressed teenagers and children if antidepressants were banned. Suicide is the third leading cause of death among teenagers, trailing only homicide and accidents. Without treatment, many more teenagers will die, several experts said. If the committee suggests an even stronger warning, some patients will resist therapy and could perhaps die, some speakers said.

Download Today's New York Times to Your Desktop.

Continued 1 | 2 | Next>>