Stronger Warning Urged on Antidepressants for Teenagers
February 3, 2004
By ERICA GOODE
BETHESDA, 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
"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
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
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 S.S.R.I's.
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
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 very effective."
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 before then.
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 enormously complicated.
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 adequate.
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 school.
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
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.