Child Anti-Depressant Use Linked To Suicide--FDA To Issue New Warnings

[Guest guest]

It's unfortunate that Prozac is still being singled out as the only " safe " ,

" approved " SSRI for use in children, but I guess this is one way to back

Lilly into the corner. When nervous doctors stop prescribing all SSRIS

except Prozac for children, there will be only one answer left as to why

those children are still found hanging from belts in their closets, jumping

off bridges and shooting themselves in the head.

How will Lilly respond then??? What will Laughren, Temple and

the others at the FDA have to say then???

It is unfortunate that they are willing to continue to sacrifice children

until the whole sordid truth is finally acknowledged.

Cassandra Dawn

Mother of one of the many children who is dead because of Prozac

=============================================================

Thanks to Lynn for sending this article

Child Anti-Depressant Use Linked To Suicide--FDA To Issue New

Warnings

By AP

Aug 20, 2004, 13:18

http://www.earthchangestv.com/secure/2004/article_3316.php

WASHINGTON

A new Food and Drug Administration analysis backs earlier suggestions of a

link between at least some antidepressants used by children and suicidal

tendencies, prompting the agency to prepare new warnings.

Exactly what those warnings will say, and which drugs will be affected,

hasn't been settled, according to FDA documents released Friday. The agency

will take the debate to its scientific advisers next month for help in

deciding.

" While there remains a signal of risk ... for some drugs in some trials, it

is important to note that the data are not black-and-white in providing a

clear and definitive answer, " FDA psychiatric drugs chief Dr.

Laughren wrote the advisory panel this week.

The controversy has simmered since last year, when British health

authorities declared that a list of popular antidepressants might sometimes

increase the risk of suicidal behavior in children and teenagers, and

declared all but one - Prozac - unsuitable for depressed youth.

It's a difficult issue to sort out because depression itself can lead to

suicide, and studies show that antidepressants have helped adult depressed

patients recover. But, Prozac is the only drug FDA-approved to treat

pediatric depression and there is little scientific evidence that any other

antidepressant works in that age group, thus deepening concern about even

potential risks.

In March, the FDA did urge doctors to monitor closely patients of all ages

for warning signs of suicide, especially when they first start the pills or

change a dose. The reason: They may cause agitation, anxiety and hostility

in a subset of patients unusually prone to rare side effects. Or, in the

time period when severe depression just starts to lift but isn't yet much

better, patients who had been too lethargic to act on suicidal thoughts

might gain the energy to do so.

Now the question is whether the drugs' labels need still more warnings - or,

most costly to industry, specific instructions not to use certain ones in

children and teenagers.

Among 25 studies involving 4,000 children and teens and eight

antidepressants, there were no completed suicides.

FDA analyzed those studies in February, sent them for a second opinion from

Columbia University researchers, and then reanalyzed them together with the

Columbia data.

The result: Lump all the studies together, and patients given any of the

antidepressants were about 1.8 times more likely to have suicidal thoughts

or behavior than patients given dummy pills, FDA reviewer Dr.

Mosholder wrote his bosses on Monday.

However, most suicidal tendencies showed up in studies with the highest

proportion of patients who had a history of a suicide attempt or suicidal

behavior before they were enrolled, noted a separate review by FDA's Dr.

Tarek Hammad. Other studies didn't even admit those high-risk patients.

Further complicating the assessment, the risk varied widely not just from

drug to drug but between studies of the same drugs, Hammad found. In

general, patients in Prozac studies showed far fewer problems those on other

drugs.

Still, " FDA will assure that the labels of the antidepressants used in

pediatric patients reflect the most recent information obtained from these

studies and analyses, " said an agency statement issued Friday.

[Guest guest]

It's unfortunate that Prozac is still being singled out as the only " safe " ,

" approved " SSRI for use in children, but I guess this is one way to back

Lilly into the corner. When nervous doctors stop prescribing all SSRIS

except Prozac for children, there will be only one answer left as to why

those children are still found hanging from belts in their closets, jumping

off bridges and shooting themselves in the head.

How will Lilly respond then??? What will Laughren, Temple and

the others at the FDA have to say then???

It is unfortunate that they are willing to continue to sacrifice children

until the whole sordid truth is finally acknowledged.

Cassandra Dawn

Mother of one of the many children who is dead because of Prozac

=============================================================

Thanks to Lynn for sending this article

Child Anti-Depressant Use Linked To Suicide--FDA To Issue New

Warnings

By AP

Aug 20, 2004, 13:18

http://www.earthchangestv.com/secure/2004/article_3316.php

WASHINGTON

A new Food and Drug Administration analysis backs earlier suggestions of a

link between at least some antidepressants used by children and suicidal

tendencies, prompting the agency to prepare new warnings.

Exactly what those warnings will say, and which drugs will be affected,

hasn't been settled, according to FDA documents released Friday. The agency

will take the debate to its scientific advisers next month for help in

deciding.

" While there remains a signal of risk ... for some drugs in some trials, it

is important to note that the data are not black-and-white in providing a

clear and definitive answer, " FDA psychiatric drugs chief Dr.

Laughren wrote the advisory panel this week.

The controversy has simmered since last year, when British health

authorities declared that a list of popular antidepressants might sometimes

increase the risk of suicidal behavior in children and teenagers, and

declared all but one - Prozac - unsuitable for depressed youth.

It's a difficult issue to sort out because depression itself can lead to

suicide, and studies show that antidepressants have helped adult depressed

patients recover. But, Prozac is the only drug FDA-approved to treat

pediatric depression and there is little scientific evidence that any other

antidepressant works in that age group, thus deepening concern about even

potential risks.

In March, the FDA did urge doctors to monitor closely patients of all ages

for warning signs of suicide, especially when they first start the pills or

change a dose. The reason: They may cause agitation, anxiety and hostility

in a subset of patients unusually prone to rare side effects. Or, in the

time period when severe depression just starts to lift but isn't yet much

better, patients who had been too lethargic to act on suicidal thoughts

might gain the energy to do so.

Now the question is whether the drugs' labels need still more warnings - or,

most costly to industry, specific instructions not to use certain ones in

children and teenagers.

Among 25 studies involving 4,000 children and teens and eight

antidepressants, there were no completed suicides.

FDA analyzed those studies in February, sent them for a second opinion from

Columbia University researchers, and then reanalyzed them together with the

Columbia data.

The result: Lump all the studies together, and patients given any of the

antidepressants were about 1.8 times more likely to have suicidal thoughts

or behavior than patients given dummy pills, FDA reviewer Dr.

Mosholder wrote his bosses on Monday.

However, most suicidal tendencies showed up in studies with the highest

proportion of patients who had a history of a suicide attempt or suicidal

behavior before they were enrolled, noted a separate review by FDA's Dr.

Tarek Hammad. Other studies didn't even admit those high-risk patients.

Further complicating the assessment, the risk varied widely not just from

drug to drug but between studies of the same drugs, Hammad found. In

general, patients in Prozac studies showed far fewer problems those on other

drugs.

Still, " FDA will assure that the labels of the antidepressants used in

pediatric patients reflect the most recent information obtained from these

studies and analyses, " said an agency statement issued Friday.

[Guest guest]

It's unfortunate that Prozac is still being singled out as the only " safe " ,

" approved " SSRI for use in children, but I guess this is one way to back

Lilly into the corner. When nervous doctors stop prescribing all SSRIS

except Prozac for children, there will be only one answer left as to why

those children are still found hanging from belts in their closets, jumping

off bridges and shooting themselves in the head.

How will Lilly respond then??? What will Laughren, Temple and

the others at the FDA have to say then???

It is unfortunate that they are willing to continue to sacrifice children

until the whole sordid truth is finally acknowledged.

Cassandra Dawn

Mother of one of the many children who is dead because of Prozac

=============================================================

Thanks to Lynn for sending this article

Child Anti-Depressant Use Linked To Suicide--FDA To Issue New

Warnings

By AP

Aug 20, 2004, 13:18

http://www.earthchangestv.com/secure/2004/article_3316.php

WASHINGTON

A new Food and Drug Administration analysis backs earlier suggestions of a

link between at least some antidepressants used by children and suicidal

tendencies, prompting the agency to prepare new warnings.

Exactly what those warnings will say, and which drugs will be affected,

hasn't been settled, according to FDA documents released Friday. The agency

will take the debate to its scientific advisers next month for help in

deciding.

" While there remains a signal of risk ... for some drugs in some trials, it

is important to note that the data are not black-and-white in providing a

clear and definitive answer, " FDA psychiatric drugs chief Dr.

Laughren wrote the advisory panel this week.

The controversy has simmered since last year, when British health

authorities declared that a list of popular antidepressants might sometimes

increase the risk of suicidal behavior in children and teenagers, and

declared all but one - Prozac - unsuitable for depressed youth.

It's a difficult issue to sort out because depression itself can lead to

suicide, and studies show that antidepressants have helped adult depressed

patients recover. But, Prozac is the only drug FDA-approved to treat

pediatric depression and there is little scientific evidence that any other

antidepressant works in that age group, thus deepening concern about even

potential risks.

In March, the FDA did urge doctors to monitor closely patients of all ages

for warning signs of suicide, especially when they first start the pills or

change a dose. The reason: They may cause agitation, anxiety and hostility

in a subset of patients unusually prone to rare side effects. Or, in the

time period when severe depression just starts to lift but isn't yet much

better, patients who had been too lethargic to act on suicidal thoughts

might gain the energy to do so.

Now the question is whether the drugs' labels need still more warnings - or,

most costly to industry, specific instructions not to use certain ones in

children and teenagers.

Among 25 studies involving 4,000 children and teens and eight

antidepressants, there were no completed suicides.

FDA analyzed those studies in February, sent them for a second opinion from

Columbia University researchers, and then reanalyzed them together with the

Columbia data.

The result: Lump all the studies together, and patients given any of the

antidepressants were about 1.8 times more likely to have suicidal thoughts

or behavior than patients given dummy pills, FDA reviewer Dr.

Mosholder wrote his bosses on Monday.

However, most suicidal tendencies showed up in studies with the highest

proportion of patients who had a history of a suicide attempt or suicidal

behavior before they were enrolled, noted a separate review by FDA's Dr.

Tarek Hammad. Other studies didn't even admit those high-risk patients.

Further complicating the assessment, the risk varied widely not just from

drug to drug but between studies of the same drugs, Hammad found. In

general, patients in Prozac studies showed far fewer problems those on other

drugs.

Still, " FDA will assure that the labels of the antidepressants used in

pediatric patients reflect the most recent information obtained from these

studies and analyses, " said an agency statement issued Friday.

[Guest guest]

It's unfortunate that Prozac is still being singled out as the only " safe " ,

" approved " SSRI for use in children, but I guess this is one way to back

Lilly into the corner. When nervous doctors stop prescribing all SSRIS

except Prozac for children, there will be only one answer left as to why

those children are still found hanging from belts in their closets, jumping

off bridges and shooting themselves in the head.

How will Lilly respond then??? What will Laughren, Temple and

the others at the FDA have to say then???

It is unfortunate that they are willing to continue to sacrifice children

until the whole sordid truth is finally acknowledged.

Cassandra Dawn

Mother of one of the many children who is dead because of Prozac

=============================================================

Thanks to Lynn for sending this article

Child Anti-Depressant Use Linked To Suicide--FDA To Issue New

Warnings

By AP

Aug 20, 2004, 13:18

http://www.earthchangestv.com/secure/2004/article_3316.php

WASHINGTON

A new Food and Drug Administration analysis backs earlier suggestions of a

link between at least some antidepressants used by children and suicidal

tendencies, prompting the agency to prepare new warnings.

Exactly what those warnings will say, and which drugs will be affected,

hasn't been settled, according to FDA documents released Friday. The agency

will take the debate to its scientific advisers next month for help in

deciding.

" While there remains a signal of risk ... for some drugs in some trials, it

is important to note that the data are not black-and-white in providing a

clear and definitive answer, " FDA psychiatric drugs chief Dr.

Laughren wrote the advisory panel this week.

The controversy has simmered since last year, when British health

authorities declared that a list of popular antidepressants might sometimes

increase the risk of suicidal behavior in children and teenagers, and

declared all but one - Prozac - unsuitable for depressed youth.

It's a difficult issue to sort out because depression itself can lead to

suicide, and studies show that antidepressants have helped adult depressed

patients recover. But, Prozac is the only drug FDA-approved to treat

pediatric depression and there is little scientific evidence that any other

antidepressant works in that age group, thus deepening concern about even

potential risks.

In March, the FDA did urge doctors to monitor closely patients of all ages

for warning signs of suicide, especially when they first start the pills or

change a dose. The reason: They may cause agitation, anxiety and hostility

in a subset of patients unusually prone to rare side effects. Or, in the

time period when severe depression just starts to lift but isn't yet much

better, patients who had been too lethargic to act on suicidal thoughts

might gain the energy to do so.

Now the question is whether the drugs' labels need still more warnings - or,

most costly to industry, specific instructions not to use certain ones in

children and teenagers.

Among 25 studies involving 4,000 children and teens and eight

antidepressants, there were no completed suicides.

FDA analyzed those studies in February, sent them for a second opinion from

Columbia University researchers, and then reanalyzed them together with the

Columbia data.

The result: Lump all the studies together, and patients given any of the

antidepressants were about 1.8 times more likely to have suicidal thoughts

or behavior than patients given dummy pills, FDA reviewer Dr.

Mosholder wrote his bosses on Monday.

However, most suicidal tendencies showed up in studies with the highest

proportion of patients who had a history of a suicide attempt or suicidal

behavior before they were enrolled, noted a separate review by FDA's Dr.

Tarek Hammad. Other studies didn't even admit those high-risk patients.

Further complicating the assessment, the risk varied widely not just from

drug to drug but between studies of the same drugs, Hammad found. In

general, patients in Prozac studies showed far fewer problems those on other

drugs.

Still, " FDA will assure that the labels of the antidepressants used in

pediatric patients reflect the most recent information obtained from these

studies and analyses, " said an agency statement issued Friday.