Fwd: [SSRI-Research] FDA Probes Use of Antidepressants on Kids

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SSRI-Research

JustSayNo

Mon, 02 Feb 2004 23:38:17 -0000

[sSRI-Research] FDA Probes Use of Antidepressants on Kids

 

[-- Just returned from Washington/the FDA review - the evidence

is ALL there - and has been since the last review in 1991. This

is a travesty... these drugs are lethal and must be labeled as so.]

 

FDA Probes Use of Antidepressants on Kids

 

Mon Feb 2,11:19 AM ET

 

http://story.news./news?tmpl==story & u==/ap/20040202/

ap_on_he_me/antidepressants_children_4

 

By LAURAN NEERGAARD, AP Medical Writer

 

WASHINGTON - Parents pleaded with the Food and Drug

Administration (news - web sites) 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.

 

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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