Another article on FDA Hearing

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http://www.usatoday.com/news/health/2006-12-12-fda-antidepressants_x.htm?csp=34 & \

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FDA panel to hear testimony on antidepressantsPosted 12/12/2006

7:27 PM ET By Marilyn Elias, USA TODAY

Fierce debate is likely at a Food and Drug Administration hearing Wednesday on

whether antidepressants can prompt adults to attempt suicide.

Opposing sides are lined up to speak before a panel of scientific advisers to

the FDA who are considering whether to recommend expanding tough label warnings

on such widely used drugs as Zoloft and Lexapro.

The agency ordered " black boxes, " the most severe safety warning, on

antidepressants in 2004, saying the drugs increased suicidal behavior in

children and teens.

At today's hearing, FDA officials will summarize adult antidepressant studies

done by pharmaceutical companies.

The findings suggest that adults up to age 24 are more than twice as likely to

think about or try suicide if they're using antidepressants than if they're

taking sugar pills. The studies didn't find that antidepressants increase

suicidal behavior for adults ages 25 to 64, and the drugs appear to reduce

suicide attempts in patients 65 and older.

The research is flawed, says psychiatrist ph Glenmullen, a clinical

instructor at Harvard Medical School, who will testify at the hearing. Most

antidepressant studies exclude patients who are seriously suicidal, " but

suicidal people are the first to get these drugs, so how much can we know if

they're not even in the studies? " he says.

Also, the FDA summarizes the risk for patients 25 to 64 years old. Patients in

some subgroups are at heightened risk. For example, those 45 to 54 years old

have about the same higher risk as youths up to age 24, says Glenmullen, author

of Prozac Backlash and The Antidepressant Solution.

Another critic questions why the FDA told companies to consider suicidal

behavior as linked to the antidepressants only if it happens while a patient is

on the drug or within one day of either stopping or beginning to taper off

treatment.

" More than half of these drugs have very clear withdrawal symptoms that can be

dangerous and go on for weeks, " says Healy, a psychiatry professor at

Cardiff University in Wales.

Many psychiatrists and spokesmen for mental health advocacy groups do not want

the FDA to broaden black-box warnings.

" Untreated depression causes more loss of life than any of the approved

treatments, " says Carolyn Robinowitz, president-elect of the American

Psychiatric Association. In her 38 years of practicing psychiatry, she says she

has never seen an increase in suicidal behavior, or a suicide, due to

antidepressants.

Black boxes have sharply reduced antidepressant use by kids, Robinowitz adds.

" A black box for adults creates a fear mentality, not only in patients but in

doctors. … It can limit access to needed care. "

Any black box ordered by the FDA " should acknowledge clearly that untreated

depression is directly linked to suicide and that antidepressant medications are

effective in treatment, " says Ken Duckworth, medical director of the National

Alliance on Mental Illness.

Find this article at:

http://www.usatoday.com/news/health/2006-12-12-fda-antidepressants_x.htm?csp=34 & \

POE=click-refer

" ...There are certain things in our nation and in the world about which I am

proud to be maladjusted and about which I hope all men of good-will will be

maladjusted...Through such maladjustment, I believe that we will be able to

emerge from the bleak and desolate midnight of man's inhumanity to man into the

bright and glittering daybreak of freedom and justice. " - Dr. Luther

King, Jr. - December 18, 1963

---------------------------------

Access over 1 million songs - Music Unlimited.

[Guest guest]

http://www.usatoday.com/news/health/2006-12-12-fda-antidepressants_x.htm?csp=34 & \

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FDA panel to hear testimony on antidepressantsPosted 12/12/2006

7:27 PM ET By Marilyn Elias, USA TODAY

Fierce debate is likely at a Food and Drug Administration hearing Wednesday on

whether antidepressants can prompt adults to attempt suicide.

Opposing sides are lined up to speak before a panel of scientific advisers to

the FDA who are considering whether to recommend expanding tough label warnings

on such widely used drugs as Zoloft and Lexapro.

The agency ordered " black boxes, " the most severe safety warning, on

antidepressants in 2004, saying the drugs increased suicidal behavior in

children and teens.

At today's hearing, FDA officials will summarize adult antidepressant studies

done by pharmaceutical companies.

The findings suggest that adults up to age 24 are more than twice as likely to

think about or try suicide if they're using antidepressants than if they're

taking sugar pills. The studies didn't find that antidepressants increase

suicidal behavior for adults ages 25 to 64, and the drugs appear to reduce

suicide attempts in patients 65 and older.

The research is flawed, says psychiatrist ph Glenmullen, a clinical

instructor at Harvard Medical School, who will testify at the hearing. Most

antidepressant studies exclude patients who are seriously suicidal, " but

suicidal people are the first to get these drugs, so how much can we know if

they're not even in the studies? " he says.

Also, the FDA summarizes the risk for patients 25 to 64 years old. Patients in

some subgroups are at heightened risk. For example, those 45 to 54 years old

have about the same higher risk as youths up to age 24, says Glenmullen, author

of Prozac Backlash and The Antidepressant Solution.

Another critic questions why the FDA told companies to consider suicidal

behavior as linked to the antidepressants only if it happens while a patient is

on the drug or within one day of either stopping or beginning to taper off

treatment.

" More than half of these drugs have very clear withdrawal symptoms that can be

dangerous and go on for weeks, " says Healy, a psychiatry professor at

Cardiff University in Wales.

Many psychiatrists and spokesmen for mental health advocacy groups do not want

the FDA to broaden black-box warnings.

" Untreated depression causes more loss of life than any of the approved

treatments, " says Carolyn Robinowitz, president-elect of the American

Psychiatric Association. In her 38 years of practicing psychiatry, she says she

has never seen an increase in suicidal behavior, or a suicide, due to

antidepressants.

Black boxes have sharply reduced antidepressant use by kids, Robinowitz adds.

" A black box for adults creates a fear mentality, not only in patients but in

doctors. … It can limit access to needed care. "

Any black box ordered by the FDA " should acknowledge clearly that untreated

depression is directly linked to suicide and that antidepressant medications are

effective in treatment, " says Ken Duckworth, medical director of the National

Alliance on Mental Illness.

Find this article at:

http://www.usatoday.com/news/health/2006-12-12-fda-antidepressants_x.htm?csp=34 & \

POE=click-refer

" ...There are certain things in our nation and in the world about which I am

proud to be maladjusted and about which I hope all men of good-will will be

maladjusted...Through such maladjustment, I believe that we will be able to

emerge from the bleak and desolate midnight of man's inhumanity to man into the

bright and glittering daybreak of freedom and justice. " - Dr. Luther

King, Jr. - December 18, 1963

---------------------------------

Access over 1 million songs - Music Unlimited.

[Guest guest]

http://www.usatoday.com/news/health/2006-12-12-fda-antidepressants_x.htm?csp=34 & \

POE=click-refer

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bnum=new Number(Math.floor(99999999 * Math.random())+1); document.write('');

FDA panel to hear testimony on antidepressantsPosted 12/12/2006

7:27 PM ET By Marilyn Elias, USA TODAY

Fierce debate is likely at a Food and Drug Administration hearing Wednesday on

whether antidepressants can prompt adults to attempt suicide.

Opposing sides are lined up to speak before a panel of scientific advisers to

the FDA who are considering whether to recommend expanding tough label warnings

on such widely used drugs as Zoloft and Lexapro.

The agency ordered " black boxes, " the most severe safety warning, on

antidepressants in 2004, saying the drugs increased suicidal behavior in

children and teens.

At today's hearing, FDA officials will summarize adult antidepressant studies

done by pharmaceutical companies.

The findings suggest that adults up to age 24 are more than twice as likely to

think about or try suicide if they're using antidepressants than if they're

taking sugar pills. The studies didn't find that antidepressants increase

suicidal behavior for adults ages 25 to 64, and the drugs appear to reduce

suicide attempts in patients 65 and older.

The research is flawed, says psychiatrist ph Glenmullen, a clinical

instructor at Harvard Medical School, who will testify at the hearing. Most

antidepressant studies exclude patients who are seriously suicidal, " but

suicidal people are the first to get these drugs, so how much can we know if

they're not even in the studies? " he says.

Also, the FDA summarizes the risk for patients 25 to 64 years old. Patients in

some subgroups are at heightened risk. For example, those 45 to 54 years old

have about the same higher risk as youths up to age 24, says Glenmullen, author

of Prozac Backlash and The Antidepressant Solution.

Another critic questions why the FDA told companies to consider suicidal

behavior as linked to the antidepressants only if it happens while a patient is

on the drug or within one day of either stopping or beginning to taper off

treatment.

" More than half of these drugs have very clear withdrawal symptoms that can be

dangerous and go on for weeks, " says Healy, a psychiatry professor at

Cardiff University in Wales.

Many psychiatrists and spokesmen for mental health advocacy groups do not want

the FDA to broaden black-box warnings.

" Untreated depression causes more loss of life than any of the approved

treatments, " says Carolyn Robinowitz, president-elect of the American

Psychiatric Association. In her 38 years of practicing psychiatry, she says she

has never seen an increase in suicidal behavior, or a suicide, due to

antidepressants.

Black boxes have sharply reduced antidepressant use by kids, Robinowitz adds.

" A black box for adults creates a fear mentality, not only in patients but in

doctors. … It can limit access to needed care. "

Any black box ordered by the FDA " should acknowledge clearly that untreated

depression is directly linked to suicide and that antidepressant medications are

effective in treatment, " says Ken Duckworth, medical director of the National

Alliance on Mental Illness.

Find this article at:

http://www.usatoday.com/news/health/2006-12-12-fda-antidepressants_x.htm?csp=34 & \

POE=click-refer

" ...There are certain things in our nation and in the world about which I am

proud to be maladjusted and about which I hope all men of good-will will be

maladjusted...Through such maladjustment, I believe that we will be able to

emerge from the bleak and desolate midnight of man's inhumanity to man into the

bright and glittering daybreak of freedom and justice. " - Dr. Luther

King, Jr. - December 18, 1963

---------------------------------

Access over 1 million songs - Music Unlimited.

[Guest guest]

http://www.usatoday.com/news/health/2006-12-12-fda-antidepressants_x.htm?csp=34 & \

POE=click-refer

OAS_RICH( " VerticalBanner " ) Advertisement var

bnum=new Number(Math.floor(99999999 * Math.random())+1); document.write('');

FDA panel to hear testimony on antidepressantsPosted 12/12/2006

7:27 PM ET By Marilyn Elias, USA TODAY

Fierce debate is likely at a Food and Drug Administration hearing Wednesday on

whether antidepressants can prompt adults to attempt suicide.

Opposing sides are lined up to speak before a panel of scientific advisers to

the FDA who are considering whether to recommend expanding tough label warnings

on such widely used drugs as Zoloft and Lexapro.

The agency ordered " black boxes, " the most severe safety warning, on

antidepressants in 2004, saying the drugs increased suicidal behavior in

children and teens.

At today's hearing, FDA officials will summarize adult antidepressant studies

done by pharmaceutical companies.

The findings suggest that adults up to age 24 are more than twice as likely to

think about or try suicide if they're using antidepressants than if they're

taking sugar pills. The studies didn't find that antidepressants increase

suicidal behavior for adults ages 25 to 64, and the drugs appear to reduce

suicide attempts in patients 65 and older.

The research is flawed, says psychiatrist ph Glenmullen, a clinical

instructor at Harvard Medical School, who will testify at the hearing. Most

antidepressant studies exclude patients who are seriously suicidal, " but

suicidal people are the first to get these drugs, so how much can we know if

they're not even in the studies? " he says.

Also, the FDA summarizes the risk for patients 25 to 64 years old. Patients in

some subgroups are at heightened risk. For example, those 45 to 54 years old

have about the same higher risk as youths up to age 24, says Glenmullen, author

of Prozac Backlash and The Antidepressant Solution.

Another critic questions why the FDA told companies to consider suicidal

behavior as linked to the antidepressants only if it happens while a patient is

on the drug or within one day of either stopping or beginning to taper off

treatment.

" More than half of these drugs have very clear withdrawal symptoms that can be

dangerous and go on for weeks, " says Healy, a psychiatry professor at

Cardiff University in Wales.

Many psychiatrists and spokesmen for mental health advocacy groups do not want

the FDA to broaden black-box warnings.

" Untreated depression causes more loss of life than any of the approved

treatments, " says Carolyn Robinowitz, president-elect of the American

Psychiatric Association. In her 38 years of practicing psychiatry, she says she

has never seen an increase in suicidal behavior, or a suicide, due to

antidepressants.

Black boxes have sharply reduced antidepressant use by kids, Robinowitz adds.

" A black box for adults creates a fear mentality, not only in patients but in

doctors. … It can limit access to needed care. "

Any black box ordered by the FDA " should acknowledge clearly that untreated

depression is directly linked to suicide and that antidepressant medications are

effective in treatment, " says Ken Duckworth, medical director of the National

Alliance on Mental Illness.

Find this article at:

http://www.usatoday.com/news/health/2006-12-12-fda-antidepressants_x.htm?csp=34 & \

POE=click-refer

" ...There are certain things in our nation and in the world about which I am

proud to be maladjusted and about which I hope all men of good-will will be

maladjusted...Through such maladjustment, I believe that we will be able to

emerge from the bleak and desolate midnight of man's inhumanity to man into the

bright and glittering daybreak of freedom and justice. " - Dr. Luther

King, Jr. - December 18, 1963

---------------------------------

Access over 1 million songs - Music Unlimited.