Some FDA officials defended the decision to sit on the report and seek more analysis of the data, but some psychiatrists and congressional leaders were angered that the agency had kept Mosholder silent.
"Evidence that they're suppressing a report like this is an outrage, given the public health and safety issues at stake," said Dr. Joseph Glenmullen, a Harvard psychiatrist who wrote a book on problems with the drugs known as serotonin reuptake inhibitors, which alter brain chemistry to manage depression. "They've been claiming that there's no evidence. Here's the evidence."
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Congress Asks for Data
Senate and House committees have ordered the FDA to hand over documents -- such as the ones obtained by The Times -- that might illuminate what the agency knew about the possible link between the drugs and suicidal behavior. They specifically asked for any of Mosholder's reports, e-mails, correspondence or notes on pediatric or adolescent antidepressant trials.
These members of Congress are concerned that the FDA may be keeping information from Americans that would help them better assess the possible risks of taking antidepressants or giving them to children.
"It would have been very wrong for the FDA to withhold any information it had about unintended consequences that might result from the use of antidepressants, especially for children and adolescents," Sen. Charles E. Grassley (R-Iowa), chairman of the Senate Finance Committee, said in a statement.
"The public deserves to know of every possible risk so that family members can closely monitor any changes in behavior," he said.
Suicide is the third leading cause of death in teenagers ages 15 to 19. From 1980 to 1997, the rate of suicide among this group increased by 11%. Suicide is rare but growing among younger children. The suicide rate for those 10 to 14 years old increased by 109% between 1980 and 1997, according to the Centers for Disease Control and Prevention.
Since peaking in the late 1990s, suicide rates appear to be declining among teenagers, but remain a serious problem. Experts say depression is the leading factor in suicide.
Depression affects 1 in every 33 children and 1 in every 8 adolescents, according to the National Mental Health Assn. Although only one antidepressant, Prozac, is explicitly approved by the FDA for children, doctors routinely prescribe others to their young patients, and the use of these drugs by children has been steadily rising.
