But Temple said he was not sorry about waiting for the Columbia study before concluding that the data suggested a clear link between the drugs and suicidal behavior among children.
It would be dangerous, he said, to prematurely rule out these drugs as possible treatment for childhood depression because there are few medical remedies available for the illness. Depression plays a significant role in suicide, the third leading cause of death in teens.
"We've thought all along, it is extremely important to get as right an answer on this as we can," Temple told reporters.
Fluoxetine hydrochloride, marketed by Eli Lilly & Co. as Prozac, is the only antidepressant approved by the FDA for use in children, because it meets the agency's standard of effectiveness in clinical trials. Doctors regularly prescribe several of the other drugs to young patients, however.
Dr. Tarek Hammad, the FDA's senior medical reviewer, said that 2% to 3% of the children treated with the antidepressants in the most recent study experienced increased suicidal behavior or thought.
The FDA analyzed 26 trials of nine antidepressants. (Lexapro was not included in these trials.) Data from 25 trials conducted by drug manufacturers were reexamined by Columbia scientists, while independent researchers conducted the 26th trial.
Dr. Andrew Mosholder, the FDA researcher who produced the earlier internal analysis showing a connection between the drugs and suicidal behavior in children, said the new report "reproduced" his findings. Mosholder's superiors had prohibited him from presenting his findings at a February FDA advisory committee meeting on the same topic.
After a morning of dispassionate scientific presentations, the committee heard from family members of children who committed acts of violence, including suicide, while taking the drugs. In emotional appeals, the relatives urged the FDA to ban the drugs.
"The senior leadership at FDA drag their feet and make Orwellian statements such as 'Just because these drugs have not been proven to be effective does not necessarily mean they're ineffective,' " said Thomas Woodward, a businessman from North Wales, Pa., whose 17-year-old daughter killed herself after taking Zoloft for seven days. The FDA officials "know the truth and therefore have blood on their hands," he said.
Raul Laguerre of Newburgh, N.Y., said his son may spend most of his life in prison because of a violent act he committed while taking one of the drugs.
