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 Parents:
Kids Face Antidepressants Risk
by Lauran Neergaard, Associated Press, February 2, 2004
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Parents pleaded
with the Food and Drug Administration on Monday to end the use
of popular adult antidepressants in children, saying the drugs
can increase youths' risk of suicide and violence.
"To die in this violent, unusual fashion without making a sound
... Paxil must have put her over the edge," said Sara Bostock,
describing how her daughter Cecily stabbed herself in the chest
with a kitchen knife shortly after graduating from Stanford
University and two weeks after starting the drug.
"You have an obligation today ... from preventing this tragic
story from being repeated over and over again," said Mark Miller
of Kansas City, Mo., whose son Matt hanged himself from his
bedroom closet after taking his seventh Zoloft tablet.
But facing those anguished complaints were a handful of families
who say antidepressants changed their children's lives by
alleviating serious depression.
"My children have had tremendous improvement with their
illnesses," said Dr. Suzanne Vogel-Scieilia of the National
Alliance for the Mentally Ill, who has two sons using the drugs.
"I shudder to think of their plight if these medicines were not
available."
The FDA opened hearings Monday on the emotionally charged
controversy, months after British health authorities first
sounded the alarm by saying an entire list of antidepressants
were unsuitable for child use.
Here, no final answer is expected until late summer. Until then
FDA has advised doctors to use great caution if they prescribe
any antidepressants to anyone under age 18.
"The wrong answer in either direction ... could have profound
consequences," said Dr. Russell Katz, FDA's director of
neurologic drugs, in explaining the lengthy deliberation.
Katz acknowledged divisions of opinion even within the FDA,
where some scientists believe there is a link between some
antidepressants and youth suicide behavior and attempts.
No studies have occurred in studies encompassing 4,000 children.
Preliminary data, however, suggest that suicidal behavior and
attempts, while infrequent, might be at least twice as frequent
among some antidepressant users. Britain put the risk at around
3.2 percent of children given the drugs, compared with 1.5
percent of those given dummy pills.
But problems with that data led FDA's leaders to conclude that
they can't yet answer the question.
Depression occurs in about 10 percent of youth and can lead to
suicide, especially if untreated. Some 1,883 10- to 19-year-olds
killed themselves in 2001, and specialists say there are 10 to
20 attempts for every suicide.
For adults, antidepressants clearly alleviate major depression,
the FDA stresses.
But medicines can work differently in children. The agency has
approved only one treatment _ Prozac, the best known of a family
of popular antidepressants called SSRIs _ to alleviate pediatric
depression, saying its benefits outweigh side effects.
Still, it is legal for doctors to prescribe adult medicines to
children even if the FDA has not formally approved pediatric
use, and child antidepressant prescriptions rose dramatically in
the 1990s. The FDA ordered other manufacturers to submit
research on how their drugs affect children and teenagers.
Last summer, British health authorities acted on the first of
those findings, declaring that no depressed child or teen should
use the SSRI drug Paxil, sold in Britain under the name Seroxat.
The FDA still is analyzing the studies.
The reports of suicidal behavior are a hodgepodge difficult to
sort out, Katz said. Some cases counted as unintentional drug
overdoses may not have been, for example, while others termed
suicidal were caused by a mental illness called self-mutilation,
where children make small cuts over their bodies. Sorting out
just what happened is crucial to settling the issue, Katz said.
For Monday's hearing, the FDA brought together its scientific
advisers to ask if it is analyzing the research appropriately,
and if families or doctors need additional advice in the
meantime.
It's a debate eliciting strong emotions.
The American College of Neuropsychopharmacology, considered the
field's top specialists, last month declared evidence that links
SSRIs to suicide 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. Dr. David Healy, a Welsh physician who pushed
for Britain's crackdown, says even he prescribes the drugs, but
that they must come with warnings so doctors can monitor
children for signs of trouble.
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