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Parents: Kids Face Antidepressants Risk

Mon Feb 2,12:19 PM ET Add Health - AP to My

By LAURAN NEERGAARD, AP Medical Writer

http://news./fc?tmpl=fc & cid=34 & in=health & cat=mental_health

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 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. 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. 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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Parents: Kids Face Antidepressants Risk

Mon Feb 2,12:19 PM ET Add Health - AP to My

By LAURAN NEERGAARD, AP Medical Writer

http://news./fc?tmpl=fc & cid=34 & in=health & cat=mental_health

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 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. 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. 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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