| Ilena Rose 2004-09-21, 3:25 am |
| Drug Warning Label Idea Prompts Caution
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By DIEDTRA HENDERSON, AP Science Writer
WASHINGTON - Alarmed at a recommendation that antidepressants for
children carry a strict new warning label, some parents are not
letting their kids take the drugs as part of a clinical trial for
young people who have attempted suicide.
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Government health advisers said last week the labels on these drugs
should have bold warnings surrounded by a black box to draw attention
and say that, in some cases, the medication increases suicidal
thoughts and behavior.
A study financed by the National Institute of Mental Health is
designed to determine whether treatment — medication or behavioral
therapy, alone or combined — can prevent future suicide attempts.
Children enrolled in the small pilot study have attempted suicide
previously, which normally would exclude them from such scientific
trials.
Dr. Graham Emslie, principal investigator at one of the study's five
sites, said only 15 percent of children diagnosed as depressed take
medication.
"We're trying to increase the number who are treated," said Emslie,
who works in Dallas, and the black box warning "is definitely not
going to help."
The Food and Drug Administration (news - web sites) said it generally
supports the recommendation from the advisory panel that labels on
antidepressants have warnings about increased risk of suicidal
thoughts and behavior.
For every 100 children taking antidepressants in controlled clinical
trials, an additional two to three experienced increased suicidal
tendencies.
In the trial, the parents of a child who had attempted suicide within
the previous 45 days — a requirement to participate in the study —
refused to let researchers use an antidepressant as planned.
In a second instance, divorced parents could not agree whether their
suicidal child should take the medication.
Emslie said two refusals by parents in a single week, each citing the
advisory panel's comments, mark the beginning of a worrisome trend. "I
don't think it was isolated. I think it will continue," Emslie said.
On Capitol Hill, lawmakers are pushing for greater disclosure of the
results from drug clinical trials.
The FDA (news - web sites) said last week it has begun to adopt more
strident warning labels for all antidepressants, not only those
involved in pediatric clinical trials: Celexa, Effexor, Luvox, Paxil,
Prozac, Remeron, Serzone, Wellbutrin and Zoloft.
The agency has not yet said whether that will be a black-box warning
as the advisory panel recommended.
Last week's public hearings on the issue have led to changes already
in how antidepressants are prescribed.
For psychiatrists like Dan Medeiros, the push to ensure that doctors
first discuss the medication's risks and benefits simply reinforces
what he has done for 14 years.
Medeiros runs a day treatment program for New York teenagers who skip
school or fail because of depression. Medeiros' warnings already
include the risk that an antidepressant can boost energy.
"People can be so depressed they don't even have the energy to get out
of bed. If the medication starts improving energy level ... you then
have the means to commit suicide," he said.
John March, chief of child and adolescent psychiatry at Duke
University Medical Center, said he's inclined to prescribe Prozac
first among the new generation of antidepressants. The federal
recommendations won't change that since three studies, including one
led by March, point to Prozac's effectiveness.
Kathy Bruce's husband, Marty, killed himself in 1993, and her
10-year-old daughter, McLain, was diagnosed as bipolar in May.
For the past month, the girl has taken Zoloft, which is linked to
increased suicidal thoughts among children. When prescribing the drug,
McLain's doctor mentioned a "small risk" associated with the
antidepressant, Kathy Bruce said.
"It was a risk I was willing to take," Bruce said from her home near
Atlanta. "She's coming home every day happy and loving school."
Dr. Phillip Kennedy said he limited antidepressant prescriptions after
the FDA in March sent a warning letter to doctors.
A black box warning would make prescribing physicians and drug
companies "liability targets," Kennedy said.
His strategy has been to tell slightly depressed adolescents and their
parents that a drug could help, but that he would prefer that a
psychiatrist prescribe it. "You get resistance from the mother and
child. It's a weekly occurrence, if not more," Kennedy said.
Dr. Elissa Benedek, past president of the American Psychiatric
Association, said referrals to mental health specialists are likely to
increase.
"If it makes some people more careful and more thoughtful about what
they do, it's not a bad thing," said Benedek, a child psychiatrist in
Ann Arbor, Mich.
In Augusta, Ga., where Kennedy runs a family practice, he said youths
can face a three-month delay before seeing a psychiatrist.
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