CHICAGO - (KRT) - Antidepressant
medications should carry "black box" warnings - the strongest
caution for prescription drugs - because they can enhance the risk
of suicidal thoughts among children and adolescents being treated
for depression, scientific advisers to the government announced
Although the risk of suicidal tendencies is low, families should
be counseled that it exists and sign release forms before beginning
such medication for their children, the scientific panel told the
U.S. Food and Drug Administration.
Psychiatrists say the recommendations, if approved, would likely
make it more difficult to prescribe antidepressants for children and
adolescents. Parents would face the difficult task of weighing the
costs and benefits of the drugs, which also have the potential to
"Every suicide is a tragedy, and any increased risk of suicidal
thoughts or behaviors - no matter how small - must be taken
seriously," said Dr. David Fassler, a trustee of the American
Psychiatric Association and a child and adolescent psychiatrist in
But Fassler also testified the association was concerned that
action by the FDA would frighten people away from treatment. "Half
of all kids who suffer from depression will attempt suicide at least
once, and at least 7 percent will die as a result," he said.
An estimated 11 million U.S. youngsters were prescribed
antidepressants in 2002, the most popular of which are Zoloft, Paxil
and Prozac. Prozac is the only antidepressant shown to be effective
in children and it is the only one approved by the FDA for use in
adolescents. Zoloft and Paxil have been found to be effective in
treating obsessive-compulsive and anxiety disorders.
A re-analysis of 25 studies involving 4,600 children and teens
taking antidepressants indicate that the risk of suicidal thoughts
or behavior is 2 to 3 percent, compared to a risk of 1.5 percent in
depressed youngsters given a placebo, or dummy drug. Psychiatrists
emphasized that none of the children in the studies committed
The studies that were analyzed varied in what was considered
suicidal behavior, making analysis difficult, the FDA said. For
example, some subjects cut themselves, but in most cases only
superficial wounds resulted.
The panel made its recommendations after two days of emotional
public hearings at which some parents said they believed
antidepressants may have played a role in their children's suicide.
The FDA generally follows the advice of its advisory panels.
Black box warnings are usually given to anti-cancer drugs and
other medications that carry a risk of causing birth defects in
pregnant women, or organ failure. In 2001 the FDA required a black
box warning for the antidepressant Serzone because of a risk of
potentially fatal liver damage.
A number of mental health experts cautioned that the strict
warning label could discourage the use of antidepressants by
adolescents who need them.
"There's growing concern that the positive effects of the
treatment are being outweighed by the negative effects," said Dr.
Graham Emslie, chief of child and adolescent psychiatry at the
University of Texas Southwestern Medical Center.
Emslie, who conducted a large study showing that Prozac was
effective in adolescents, said the black box warning could cause
physicians not to prescribe antidepressants for fear of being
"The blanket removal of available effective treatments would be a
problem," Emslie said. "We feel that choice is an important issue.
Not everybody responds to the first line of treatment."
Emslie and other mental health experts said they have gotten
calls from parents worried that they may not be able to get
antidepressants for children who have been greatly helped by the
Dr. Wayne Goodman, chief of psychiatry at the University of
Florida and chairman of the FDA advisory panel, acknowledged those
concerns but said the stronger warning label should be applied.
"I think that's worth the complication, because it will raise the
threshold to prescribing these drugs" to minors, he said.
Psychiatrists pointed to the recently published results of the
federally funded Treatment for Adolescents with Depression Study, or
TADS, which found that more than 7 out of 10 depressed youngsters
responded favorably to a combination of Prozac and a form of talk
therapy. Among those taking a placebo, the response rate was 35
Fassler said "most clinicians believe ... that for children and
adolescents who suffer from depression, the potential benefit of
these medications far outweighs the risks."
Dr. Mark Reinecke, the Northwestern professor of psychiatry and
behavioral sciences who was the lead author of the TADS study, said
the challenge now is to determine why drugs sometimes trigger the
"We have to establish the markers for risk in individual children
who will be receiving these drugs," he said.
To ban their use in adolescents, the way the British have done,
would have been "a serious mistake," said Dr. William McKinney,
director of Northwestern's Asher Center for the Study and Treatment
of Depressive Disorders.
McKinney said that these drugs already are approved for use in
childhood obsessive-compulsive and other anxiety disorders. "The
overlap behind anxiety and depression is very, very high. So one
would be depriving people of effective treatments if their use was
limited in any way."
(Chicago Tribune correspondent Bonnie Miller Rubin contributed to
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