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
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
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
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,
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.