ETHESDA, Md., Feb. 2 — A scientific advisory
panel urged the Food and Drug Administration on Monday to issue
stronger warnings to doctors now about the possible risks to
children of a newer generation of antidepressant drugs, rather than
wait until the agency's review of the drugs was completed.
"Our sense is that we would like in the interim for the F.D.A. to
go ahead and issue stronger warning indications to clinicians" about
the chance that the antidepressants might be linked to suicidal
thinking and behavior, hostility or other forms of violent behavior,
said Dr. Matthew Rudorfer, a scientist at the National Institute of
Mental Health and the chairman of the F.D.A. advisory committee.
Dr. Rudorfer said such a warning would not discourage doctors
from using the antidepressants but would alert them to warning signs
that a drug might be having harmful effects.
The recommendation came at the end of an emotional daylong public
hearing on the issue. Most of the antidepressants belong to the
class known as selective serotonin reuptake inhibitors, or
Dr. Thomas Laughren, the team leader for the F.D.A.'s division of
neuropharmacological drug products, said that the agency took the
panel's recommendation "very seriously" and that it would probably
issue such a warning "sooner rather later."
Along with experts who testified at the hearing, the panel
listened to parent after parent, and children, who stepped up to the
microphone to tell stories of suffering and loss. A father spoke of
his 13-year-old son who hanged himself from a closet hook after
starting on an antidepressant. A teenager said that after a few
weeks on the drugs he took a hunting rifle to school and threatened
his classmates. He had no memory of his actions, he said, and woke
up afterward in a juvenile detention center.
One mother asked, "How many more people have to die before a
warning gets issued?"
Other parents said the antidepressants had helped their children
enormously and saved many other children's lives.
"I shudder to think of their plight if these medications were not
available," said a mother whose son suffers from
Dr. Rudorfer said the committee was struck by the fact that in
some cases described at the hearing doctors had seemingly prescribed
antidepressants casually and failed to monitor the children closely
while they were taking them.
"We were all concerned about the stories we heard," Dr. Rudorfer
said, noting that the drugs were "very powerful but also potentially
In December, British drug regulators told doctors to stop writing
new prescriptions for children under 18 for six newer
antidepressants because the potential risks outweighed benefits. Use
of the drugs might still be warranted in some cases, the regulators
said, and they exempted Prozac from the order.
The F.D.A. has been conducting its own review of the safety and
effectiveness of the antidepressants, but has not yet taken action
to stiffen warning labels or restrict use of the drugs. Officials
from the agency said the investigation would probably not be
completed until summer and that another public hearing would be held
Dr. Laughren told the advisory committee on Monday that the
agency was reviewing 25 studies of nine antidepressants, involving
more than 4,000 patients. The drugs under review include Prozac,
which is made by Eli Lilly; Zoloft, by Pfizer; Paxil, by
GlaxoSmithKline; Luvox, by Solvay; Celexa, by Forest Laboratories;
Wellbutrin, by GlaxoSmithKline; Effexor, by Wyeth; Serzone, by
Bristol-Myers Squibb, and Remeron, by Akzo Nobel.
He said there was "a suggestion from that data that there is a
signal of something, there is an excess of something occurring." But
trying to figure out what that "something" is, Dr. Laughren said, is
At the hearing, Dr. Laughren and other F.D.A. officials asked the
panel to advise them on several questions, including whether their
plans for analyzing the existing studies of the antidepressants are
The F.D.A. has asked researchers at Columbia University to trace
the data used in the drugs' clinical trials to make sure that
behaviors coded in the trials as suicidal in fact represent suicidal
thoughts or actions.
Parents and some psychiatrists have been critical of the F.D.A.
for taking so long to investigate.
"I don't think much is going to come of this," said Jay
Baadsgaard, of Yelm, Wash., whose son took the hunting rifle to
Some parents also say the F.D.A. is too heavily influenced by the
drug industry, which heavily promotes antidepressants for a variety
of psychiatric problems including depression, social phobia, anxiety
disorders and obsessive-compulsive disorder.
About 11 million prescriptions for a group of newer
antidepressants were written for American children under 18 in 2002,
according to the F.D.A.
Some parents at the hearing, who had two minutes each to tell
their stories, described how their children seemed to change
abruptly after starting the drugs, becoming aggressive, suicidal or
violent toward others.
But Dr. David Shaffer, a professor of psychiatry at Columbia,
told the advisory panel that suicide rates among children and
adolescents had declined in recent years and that the growing use of
antidepressants was a possible explanation for the drop.
home delivery of The Times from $2.90/week