FDA mulls antidepressant warning

Is Sheila the new Todd Gastaldo?
--

Jamie & Taylor
Earth Angel, 1/3/03

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Password: Guest1
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wrote in message
...
FDA mulls antidepressant warning
Panel cites risks to some children, notes benefits too



http://www.chicagotribune.com/news/n...eb03,1,5268100
..story?coll=chi-newsnationworld-hed



By Erica Goode
New York Times News Service








BETHESDA, Md. -- A scientific advisory panel urged the Food and Drug
Administration on Monday to issue stronger warnings to doctors about the
possible risks to children of a newer generation of antidepressant drugs,
rather
than wait until the agency's review of the drugs is completed.

Our sense is that we would like in the interim for the FDA to go ahead and
issue
stronger warning indications to clinicians" about the chance that the
antidepressants might be linked to suicidal thinking and behavior,
hostility or
other forms of violent behavior, said Dr. Matthew Rudorfer, a scientist at
the
National Institute of Mental Health and the chairman of the FDA advisory
committee.

Rudorfer said that such a warning should not discourage doctors from using
the
antidepressants but would alert them to warning signs that a drug might be
having harmful effects. The recommendation came at the end of an emotional
daylong public hearing on the issue. Most of the antidepressants belong to
the
class known as selective serotonin reuptake inhibitors, or SSRIs.

Dr. Thomas Laughren, the team leader for the FDA's division of
neuropharmacological drug products, said the agency took the committee's
recommendation "very seriously" and that it would probably issue such a
warning
"sooner rather later."

The FDA has been conducting its own review of the safety and effectiveness
of
the antidepressants, but has not taken action to stiffen warning labels or
restrict use of the drugs.

Along with experts who testified at the hearing, the panel listened to
parent
after parent, and children, who stepped up to the microphone to tell
stories of
suffering and loss.

A father spoke of his 13-year-old son who hanged himself from a closet
hook
after starting on an antidepressant. A teenager said that after a few
weeks on
the drugs, he took a hunting rifle to school and threatened his
classmates. He
had no memory of his actions, he said, and woke up afterward in a juvenile
detention center.

"How many more people have to die before a warning gets issued?" asked one
mother.

Other parents said the antidepressants had helped their children
enormously and
saved many other children's lives.

"I shudder to think of their plight if these medications were not
available,"
said a mother whose son suffers from manic-depression.

Rudorfer said the committee was struck by the fact that in some cases
described
at the hearing, doctors had seemingly prescribed antidepressants casually
and
failed to monitor the children closely while they were taking them.

"We were all concerned about the stories we heard," Rudorfer said, noting
that
the drugs are "very powerful but also potentially very effective."

In December, British drug regulators told doctors to stop writing new
prescriptions for six newer antidepressants because the potential risks
outweighed their benefits. Use of the drugs might still be warranted in
some
cases, the regulators said, and they exempted Prozac from the order.

Laughren told the advisory committee on Monday that the agency is
reviewing 25
studies of nine antidepressants, involving more than 4,000 patients. The
drugs
under review include Prozac, which is made by Eli Lilly; Zoloft, by
Pfizer;
Paxil, by GlaxoSmithKline; Luvox, by Solvay; Celexa, by Forest
Laboratories;
Wellbutrin, by GlaxoSmithKline; Effexor, by Wyeth; Serzone, by
Bristol-Myers
Squibb; and Remeron, by Akzo Nobel.

He said there is "a suggestion from that data that there is a signal of
something, there is an excess of something occurring." But trying to
figure out
what that "something" is, Laughren said, is enormously complicated.

At the hearing on Monday, Laughren and other FDA officials asked the
scientists
on the committee to advise them on several questions, including whether
their
plans for analyzing the existing studies of the antidepressants are
adequate.

The FDA has asked researchers at Columbia to track back the data used in
the
clinical trials of the drugs to make sure that behaviors coded in the
trials as
suicidal in fact represent suicidal thoughts or actions.

Parents and some psychiatrists have been critical of the FDA for taking so
long
to conduct its investigation.

About 11 million prescriptions for a group of newer antidepressants were
written
for children under 18 in 2002 in the United States, according to the FDA.

Some of the parents at the hearing, who had two minutes each to tell their
stories, described how their children seemed to change abruptly after
starting
the drugs, becoming aggressive, suicidal or violent towards others.

But Dr. David Shaffer, a professor of psychiatry at Columbia, told the
advisory
panel that suicide rates among children and adolescents has declined in
recent
years, and that the growing use of antidepressants was one possible
explanation.

"Jamie Clark" wrote in message
ink.net...
Is Sheila the new Todd Gastaldo?
--



On a more obnoxious level, I'd say.

Denise

How do you "kill file"? I can't take her anymore...

"Jamie Clark" wrote in message
ink.net...
Is Sheila the new Todd Gastaldo?
--

Jamie & Taylor
Earth Angel, 1/3/03

Check out Taylor Marlys -- www.MyFamily.com, User ID: Clark_guest,
Password: Guest1
Become a member for free - go to Add Member to set up your own User ID and
Password

Handmade Baby Blankets -- www.geocities.com/digit_the_cat/Blankets.html


wrote in message
...
FDA mulls antidepressant warning
Panel cites risks to some children, notes benefits too




http://www.chicagotribune.com/news/n...eb03,1,5268100
.story?coll=chi-newsnationworld-hed



By Erica Goode
New York Times News Service








BETHESDA, Md. -- A scientific advisory panel urged the Food and Drug
Administration on Monday to issue stronger warnings to doctors about the
possible risks to children of a newer generation of antidepressant
drugs,
rather
than wait until the agency's review of the drugs is completed.

Our sense is that we would like in the interim for the FDA to go ahead
and
issue
stronger warning indications to clinicians" about the chance that the
antidepressants might be linked to suicidal thinking and behavior,
hostility or
other forms of violent behavior, said Dr. Matthew Rudorfer, a scientist
at
the
National Institute of Mental Health and the chairman of the FDA advisory
committee.

Rudorfer said that such a warning should not discourage doctors from
using
the
antidepressants but would alert them to warning signs that a drug might
be
having harmful effects. The recommendation came at the end of an
emotional
daylong public hearing on the issue. Most of the antidepressants belong
to
the
class known as selective serotonin reuptake inhibitors, or SSRIs.

Dr. Thomas Laughren, the team leader for the FDA's division of
neuropharmacological drug products, said the agency took the committee's
recommendation "very seriously" and that it would probably issue such a
warning
"sooner rather later."

The FDA has been conducting its own review of the safety and
effectiveness
of
the antidepressants, but has not taken action to stiffen warning labels
or
restrict use of the drugs.

Along with experts who testified at the hearing, the panel listened to
parent
after parent, and children, who stepped up to the microphone to tell
stories of
suffering and loss.

A father spoke of his 13-year-old son who hanged himself from a closet
hook
after starting on an antidepressant. A teenager said that after a few
weeks on
the drugs, he took a hunting rifle to school and threatened his
classmates. He
had no memory of his actions, he said, and woke up afterward in a
juvenile
detention center.

"How many more people have to die before a warning gets issued?" asked
one
mother.

Other parents said the antidepressants had helped their children
enormously and
saved many other children's lives.

"I shudder to think of their plight if these medications were not
available,"
said a mother whose son suffers from manic-depression.

Rudorfer said the committee was struck by the fact that in some cases
described
at the hearing, doctors had seemingly prescribed antidepressants
casually
and
failed to monitor the children closely while they were taking them.

"We were all concerned about the stories we heard," Rudorfer said,
noting
that
the drugs are "very powerful but also potentially very effective."

In December, British drug regulators told doctors to stop writing new
prescriptions for six newer antidepressants because the potential risks
outweighed their benefits. Use of the drugs might still be warranted in
some
cases, the regulators said, and they exempted Prozac from the order.

Laughren told the advisory committee on Monday that the agency is
reviewing 25
studies of nine antidepressants, involving more than 4,000 patients. The
drugs
under review include Prozac, which is made by Eli Lilly; Zoloft, by
Pfizer;
Paxil, by GlaxoSmithKline; Luvox, by Solvay; Celexa, by Forest
Laboratories;
Wellbutrin, by GlaxoSmithKline; Effexor, by Wyeth; Serzone, by
Bristol-Myers
Squibb; and Remeron, by Akzo Nobel.

He said there is "a suggestion from that data that there is a signal of
something, there is an excess of something occurring." But trying to
figure out
what that "something" is, Laughren said, is enormously complicated.

At the hearing on Monday, Laughren and other FDA officials asked the
scientists
on the committee to advise them on several questions, including whether
their
plans for analyzing the existing studies of the antidepressants are
adequate.

The FDA has asked researchers at Columbia to track back the data used in
the
clinical trials of the drugs to make sure that behaviors coded in the
trials as
suicidal in fact represent suicidal thoughts or actions.

Parents and some psychiatrists have been critical of the FDA for taking
so
long
to conduct its investigation.

About 11 million prescriptions for a group of newer antidepressants were
written
for children under 18 in 2002 in the United States, according to the
FDA.

Some of the parents at the hearing, who had two minutes each to tell
their
stories, described how their children seemed to change abruptly after
starting
the drugs, becoming aggressive, suicidal or violent towards others.

But Dr. David Shaffer, a professor of psychiatry at Columbia, told the
advisory
panel that suicide rates among children and adolescents has declined in
recent
years, and that the growing use of antidepressants was one possible
explanation.

New York Jen wrote:

How do you "kill file"? I can't take her anymore...

You're using Outlook (and Windows, I assume), therefore you would have
to use a filter. Killfiles are unix babies.

On Fri, 13 Feb 2004 07:14:56 GMT, "Jamie Clark"
wrote:

Is Sheila the new Todd Gastaldo?

No. Unlike Todd, Sheila has *admitted* that she's crazy.

Naomi

Vicky Bilaniuk wrote in message
. ..
New York Jen wrote:

How do you "kill file"? I can't take her anymore...

You're using Outlook (and Windows, I assume), therefore you would have
to use a filter. Killfiles are unix babies.

Outlook:
Click on one of her (smallest!) messages. Go to messages up at the top. Just
over half way down the list it should say "block sender" Click on that and
she should be added to the blocked sender list.
I'm about to use it too... If she canges her email adress you may need to
redo her.
I can cope with someone banging on about the same issue, even if they're
offensive, because I can see that they're one track minding (and ignore
it)-but I hate it when they just post extracts from other (not necessarily
correct sources) without any reason. They tend to be large messages
too-that's why I killfiled Todd, I actually found him amusing.
I mean how many people are going to read through 13 messages on the same
basic subject of 3-19kb.
If someone asks then fine, post your opinion and references to help them,
but I don't take research posted like that seriously, as it's unlikely to
give an unbiased view of current research as they'll ignore anything that
doesn't back them up.
In UK anti-depressants are not on the recommended list of drugs that
pregnant women can have. that's because there has not been enough research
here to say that they're not dangerous, not because they're definitely
dangerous. (e.g. I was refused B6 for morning sickness as it wasn't
recommended here as it hasn't been tested on enough pregnant ladies) How
many pregnant ladies are willing to put their babies at unnecessary risk?
However the guidelines for GP s says that it can be more risky for a
pregnant lady not to have anti-depressants, hence if they are needed, then
to prescribe them. Hence the advice she's giving may be more dangerous than
what she's trying to warn against. Certainly if she causes someone to
suddenly stop taking them.
Debbie

Jamie Clark wrote in message
ink.net...
Is Sheila the new Todd Gastaldo?
--

Jamie & Taylor
Earth Angel, 1/3/03

Check out Taylor Marlys -- www.MyFamily.com, User ID: Clark_guest,
Password: Guest1
Become a member for free - go to Add Member to set up your own User ID and
Password

Handmade Baby Blankets -- www.geocities.com/digit_the_cat/Blankets.html
82 messages. Just deleted. Just think of the waste of time...
Debbie

On Fri, 13 Feb 2004 15:01:12 GMT, "New York Jen"
wrote:

How do you "kill file"? I can't take her anymore...

This is how you kill file on Agent:

1) Go to the Message Menu.
2) Select Filter.
3) Add Kill Filter.

Then you can either kill file by subject or author.

3)
--
Daye
Momma to Jayan and Leopold
See Jayan and Leo: http://www.aloofhosting.com/jayleo/

On Fri, 13 Feb 2004 16:38:31 +0100, wrote:

You don't want the SSRI's nonprescription. Trust me. They're nasty
little buggers.

-Naomi

This is a forgery of my name and a particularly clumsy one at that. In
order to avoid the risk of anyone mistaking someone else's views for
mine, I am withdrawing temporarily from this newsgroup. Anything you
see under my name can be presumed to be a forgery hereafter. I'll
resurface with a birth post when the baby comes, and re-evaluate the
possibility of future posts then.

I'm sorry to have to do this; I knew she would misrepresent the truth
and I knew she would misrepresent my views, but I did not think she
would steal and misrepresent my name.

Naomi Rivkis
#1 EDD 3/06/04

"Naomi Rivkis" wrote in message
...

I'm sorry to have to do this; I knew she would misrepresent the truth
and I knew she would misrepresent my views, but I did not think she
would steal and misrepresent my name.

Oh, don't go, Naomi. It's obvious from the headers that ac@nospam isn't
you, so you needn't think anyone will be fooled. Don't be run out by some
twit. Killfile her, as many have done, and forget about her.

Best wishes,

Donna