http://www.cnn.com/2004/HEALTH/parenting/01/30/antidepressants.kids.ap/index.html
FDA to debate antidepressant risk to kids
Friday, January 30, 2004 Posted: 10:40 AM EST (1540 GMT)
. Depression a common, but treatable, disease [Fred A. Baughman Jr., MD:
their headline]
[Fred A. Baughman Jr., MD:
Craig, Greg, here they are, out of the closet, now calling, the
normal, ubiquitous emotion, depression, a disease. They have been cautious,
too ashamed, to speak the word forthrightly for 2-3 decades, resorting to
"disorder" --meaning the same thing. Now here they are up front about it.
Their two-fold commission from pharma is evident here (1) invent, fortify
diseases (2) say whatever it takes to convey the safety, efficacy,
necessity of the drug/drugs, no matter what their potential to cause injury,
death. Craig, see the 1995 call of psychiatrist, Weery of New Zealand to
ban the tricyclic antidepressant, desipramine, in children as it was causing
heart deaths, only to be shouted down by US psychiatry, in particular,
Biederman of Harvard, a hired gun. --Fred ]
WASHINGTON (AP) -- Parents of children with depression must sort through
an emotionally charged controversy in deciding on treatment: Do popular
adult antidepressants sometimes increase the risk of suicide when
they're given to kids?
British authorities last month declared a list of common antidepressants
unsuitable for children, citing that possibility. Next week, U.S. health
authorities open public hearings on the issue, at which parents who
blame the drugs for children's deaths are expected to face families who
credit the same pills for saving lives.
It's a difficult question, as depression occurs in about 10 percent of
youth, and depression can lead to suicide. Some 1,883 10- to
19-year-olds killed themselves in 2001, and specialists say there are 10
to 20 attempts for every suicide.
Antidepressants called SSRIs, such as Paxil, Zoloft and Effexor, have
been long used by adults, and authorities say there's no evidence of a
suicide risk for them.
But medicines can work differently in children, and only carefully
controlled studies can prove if suicidal behavior is more common among
youths taking SSRIs. The same holds for determining whether if a risk is
proved, is the risk because the drug just did not alleviate the
depression or had had some other effect.
No suicides have occurred in studies encompassing 4,000 children. But
preliminary data suggest suicidal behavior and attempts, while
infrequent, might be two to three times greater among users of some
SSRIs: roughly 3.2 percent among children getting the drugs compared
with 1.5 percent among those given dummy pills.
The possible risk was spotted after the U.S. Food and Drug
Administration, seeing pediatric SSRI use rising, ordered research to
see whether they work in children.
So far, the FDA has approved just one SSRI -- Prozac -- for use in
depressed patients under age 18, but the agency says none of the others
are yet proven to alleviate pediatric depression.
Lack of benefit in the face of possible risk led to Britain's warning
that SSRIs other than Prozac are unsuitable for children. Here, FDA
still is analyzing the research; it hopes to have recommendations by
summer.
"Obviously there are many pediatric psychiatrists who believe in these
drugs, but definitive advice on what to do is still pending," says Dr.
Russell Katz, FDA's chief of neurological drugs. "Now, we can only say
use them with caution."
Emotional debate
For 18-year-old Jame Tierney of Kernersville, North Carolina, that's not
enough warning. On Monday, Jame will tell the FDA that fury and thoughts
of suicide consumed her while taking Effexor -- an experience her family
wants the government to pay special heed to because Jame wasn't
depressed when she started the drug at age 14. It was prescribed for
migraine headaches.
A year of the starting dose induced some jitteriness. But when the
headaches returned and the doctor doubled the dose, Jame's parents say
their daughter went from a sweet, popular honor student to a raging
loner.
(I think these drugs have a place even in these age groups, but my
ability ... to use these drugs safely is going to be enhanced if they
come with the right warnings.
-- Dr. David Healy )
"I hated my family, my friends and most of all myself," Jame says,
describing screaming fits and hard-to-control impulses such as once
lightly cutting her wrist with a razor until the pain stopped her.
Effexor maker Wyeth Pharmaceuticals wrote doctors in August to warn that
while a cause-and-effect isn't certain, its studies show more
suicide-related thinking in children taking the drug than those given
dummy pills, including a 2 percent incidence of hostility.
The debate elicits strong emotions.
"The aim is to do no harm. Leaving it (depression) untreated is not
'doing no harm,"' says Dr. Graham Emslie of the University of Texas
Southwestern Medical Center. [Fred A. Baughman Jr., MD:
Calling depression, however mild or
severe a disease is fraudulent and fundamentally abrogating the informed
consent rights of the patient/family]
He co-chaired a task force of the American College of
Neuropsychopharmacology that last week declared evidence that links
SSRIs to suicide is too weak to justify not using them. The group points
to evidence that suicides have dropped as SSRI use increased around the
world, and to autopsy studies that show most suicides hadn't taken an
anti-depressant, or the right dose, just before their deaths.
On the other side, critics claim SSRIs sometimes cause agitation and
urgent anxiety, called akathisia, that could make certain people
suicidal.
"I think these drugs have a place even in these age groups, but my
ability ... to use these drugs safely is going to be enhanced if they
come with the right warnings," says Dr. David Healy, director of the
North Wales Department of Psychological Medicine, who helped trigger
Britain's review.
Day-to-day, doctors and parents are caught in the middle.
"The kids are in distress at this moment, so we have to work with the
information currently available," says Dr. Joseph Gold, director of
pediatric psychiatry at McLean Hospital, affiliated with Harvard Medical
School.
He's reassured at the apparent low incidence of problems and notes that
older antidepressants have far more common side effects but prescribes
the lowest possible dose.
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