Antidepressants increase the risk of suicidal behavior for people up to age 24

[Guest guest]

http://www.cumberlink.com/articles/2006/12/13/ap/health/d8m06tg00.txt

FDA May Expand Antidepressant Warning

By ANDREW BRIDGES

WASHINGTON - Antidepressants increase the risk of suicidal behavior for people

up to age 24, the government said Wednesday. It plans new warning labels and

says users of all ages should be closely monitored.

The label change proposed Wednesday would expand a warning now on the

antidepressants that applies only to children and adolescents.

The Food and Drug Administration put forth its plan to update the drug labels at

a meeting of outside advisers on the issue. The changes also would include a

recommendation for careful monitoring, especially when patients are beginning

treatment.

Public reaction was split, with some saying the changes were overdue and others

arguing they could keep drugs from those who need them.

In emotional testimony illustrated at times by slides of family photos,

relatives of suicide victims pleaded for the new warnings.

Suzanne , shouting and in tears, goaded the panel to action, telling the

experts that her 40-year-old husband who had been taking Paxil shot himself.

" I wake up every morning thinking, 'Oh my God, he's dead. He is freaking dead.'

Do you wake up and think, 'How many people are going to die today because I am

doing nothing?' " asked.

Still, mental health experts worry that additional warnings could curtail use of

the drugs and ultimately do more harm than good.

Dr. Mann, a Columbia University psychiatrist, suggested simply replacing

the proposed expanded warnings with the recommendation that doctors more closely

monitor their patients.

" We can do more good by providing more treatment for depressed children and

adults, " Mann said.

The FDA proposed the changes after completing a review that found use of the

drugs may increase the risk of suicidal thoughts and behavior among young adults

18 to 24, as well as among younger patients.

Psychiatrists testified Wednesday that the 2004 addition of a warning for

children led to a falloff in antidepressant prescriptions being written for

patients under 18 _ and an increase in suicides in that age group.

Still, overall use of antidepressants continues to grow, with nearly 190 million

prescriptions dispensed in the United States last year, according to IMS Health,

a health care information company. That suggests doctors have placed more weight

on the long-term benefits of the drugs than on any short-term risks, said Dr.

Laughren, director of the FDA's division of psychiatry products.

Expanding the " black box " or other warnings on the drugs could dissuade patients

from seeking or starting treatment, mental health experts said. They warned that

people with untreated depression _ about half of those who suffer from the

disease _ face an estimated 15 percent greater likelihood of death by suicide.

Dr. ph Glenmullen, a Harvard Medical School clinical instructor in

psychiatry and author of " Prozac Backlash, " said expanding the warnings wouldn't

scare off patients, but instead would allow them to make informed choices.

The FDA recently completed a review of 372 studies involving about 100,000

patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil.

When the results were analyzed by age, it became clear there was an elevated

though small and short-term risk for suicidal thoughts and behavior among adults

18 to 24, the FDA said in documents released ahead of Wednesday's meeting of its

psychopharmacologic drugs advisory committee.

The FDA's analysis of the multiple studies suggests an age-related shift in the

risk of suicidal thoughts and behavior associated with treatment with the drugs.

For instance, antidepressants seem to protect against suicidal thoughts and

behavior in adults 30 and older, with the effect most pronounced in patients

over 65.

The FDA said the increased risk could mean as many as 14 additional cases of

suicidal thoughts or behavior in every 1,000 children treated with

antidepressants. For adults 18 to 24, there could be four additional such cases

per 1,000.

In May, GlaxoKline and the FDA warned Paxil may raise the risk of suicidal

behavior in young adults and added that to the drug's label.

" Anytime suicide is involved it is a tragic outcome. It is one of the things

that keeps us motivated to search for better treatments because depression can

be a fatal illness, " GlaxoKline spokeswoman Anne Rhyne said.

[Guest guest]

http://www.cumberlink.com/articles/2006/12/13/ap/health/d8m06tg00.txt

FDA May Expand Antidepressant Warning

By ANDREW BRIDGES

WASHINGTON - Antidepressants increase the risk of suicidal behavior for people

up to age 24, the government said Wednesday. It plans new warning labels and

says users of all ages should be closely monitored.

The label change proposed Wednesday would expand a warning now on the

antidepressants that applies only to children and adolescents.

The Food and Drug Administration put forth its plan to update the drug labels at

a meeting of outside advisers on the issue. The changes also would include a

recommendation for careful monitoring, especially when patients are beginning

treatment.

Public reaction was split, with some saying the changes were overdue and others

arguing they could keep drugs from those who need them.

In emotional testimony illustrated at times by slides of family photos,

relatives of suicide victims pleaded for the new warnings.

Suzanne , shouting and in tears, goaded the panel to action, telling the

experts that her 40-year-old husband who had been taking Paxil shot himself.

" I wake up every morning thinking, 'Oh my God, he's dead. He is freaking dead.'

Do you wake up and think, 'How many people are going to die today because I am

doing nothing?' " asked.

Still, mental health experts worry that additional warnings could curtail use of

the drugs and ultimately do more harm than good.

Dr. Mann, a Columbia University psychiatrist, suggested simply replacing

the proposed expanded warnings with the recommendation that doctors more closely

monitor their patients.

" We can do more good by providing more treatment for depressed children and

adults, " Mann said.

The FDA proposed the changes after completing a review that found use of the

drugs may increase the risk of suicidal thoughts and behavior among young adults

18 to 24, as well as among younger patients.

Psychiatrists testified Wednesday that the 2004 addition of a warning for

children led to a falloff in antidepressant prescriptions being written for

patients under 18 _ and an increase in suicides in that age group.

Still, overall use of antidepressants continues to grow, with nearly 190 million

prescriptions dispensed in the United States last year, according to IMS Health,

a health care information company. That suggests doctors have placed more weight

on the long-term benefits of the drugs than on any short-term risks, said Dr.

Laughren, director of the FDA's division of psychiatry products.

Expanding the " black box " or other warnings on the drugs could dissuade patients

from seeking or starting treatment, mental health experts said. They warned that

people with untreated depression _ about half of those who suffer from the

disease _ face an estimated 15 percent greater likelihood of death by suicide.

Dr. ph Glenmullen, a Harvard Medical School clinical instructor in

psychiatry and author of " Prozac Backlash, " said expanding the warnings wouldn't

scare off patients, but instead would allow them to make informed choices.

The FDA recently completed a review of 372 studies involving about 100,000

patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil.

When the results were analyzed by age, it became clear there was an elevated

though small and short-term risk for suicidal thoughts and behavior among adults

18 to 24, the FDA said in documents released ahead of Wednesday's meeting of its

psychopharmacologic drugs advisory committee.

The FDA's analysis of the multiple studies suggests an age-related shift in the

risk of suicidal thoughts and behavior associated with treatment with the drugs.

For instance, antidepressants seem to protect against suicidal thoughts and

behavior in adults 30 and older, with the effect most pronounced in patients

over 65.

The FDA said the increased risk could mean as many as 14 additional cases of

suicidal thoughts or behavior in every 1,000 children treated with

antidepressants. For adults 18 to 24, there could be four additional such cases

per 1,000.

In May, GlaxoKline and the FDA warned Paxil may raise the risk of suicidal

behavior in young adults and added that to the drug's label.

" Anytime suicide is involved it is a tragic outcome. It is one of the things

that keeps us motivated to search for better treatments because depression can

be a fatal illness, " GlaxoKline spokeswoman Anne Rhyne said.

[Guest guest]

http://www.cumberlink.com/articles/2006/12/13/ap/health/d8m06tg00.txt

FDA May Expand Antidepressant Warning

By ANDREW BRIDGES

WASHINGTON - Antidepressants increase the risk of suicidal behavior for people

up to age 24, the government said Wednesday. It plans new warning labels and

says users of all ages should be closely monitored.

The label change proposed Wednesday would expand a warning now on the

antidepressants that applies only to children and adolescents.

The Food and Drug Administration put forth its plan to update the drug labels at

a meeting of outside advisers on the issue. The changes also would include a

recommendation for careful monitoring, especially when patients are beginning

treatment.

Public reaction was split, with some saying the changes were overdue and others

arguing they could keep drugs from those who need them.

In emotional testimony illustrated at times by slides of family photos,

relatives of suicide victims pleaded for the new warnings.

Suzanne , shouting and in tears, goaded the panel to action, telling the

experts that her 40-year-old husband who had been taking Paxil shot himself.

" I wake up every morning thinking, 'Oh my God, he's dead. He is freaking dead.'

Do you wake up and think, 'How many people are going to die today because I am

doing nothing?' " asked.

Still, mental health experts worry that additional warnings could curtail use of

the drugs and ultimately do more harm than good.

Dr. Mann, a Columbia University psychiatrist, suggested simply replacing

the proposed expanded warnings with the recommendation that doctors more closely

monitor their patients.

" We can do more good by providing more treatment for depressed children and

adults, " Mann said.

The FDA proposed the changes after completing a review that found use of the

drugs may increase the risk of suicidal thoughts and behavior among young adults

18 to 24, as well as among younger patients.

Psychiatrists testified Wednesday that the 2004 addition of a warning for

children led to a falloff in antidepressant prescriptions being written for

patients under 18 _ and an increase in suicides in that age group.

Still, overall use of antidepressants continues to grow, with nearly 190 million

prescriptions dispensed in the United States last year, according to IMS Health,

a health care information company. That suggests doctors have placed more weight

on the long-term benefits of the drugs than on any short-term risks, said Dr.

Laughren, director of the FDA's division of psychiatry products.

Expanding the " black box " or other warnings on the drugs could dissuade patients

from seeking or starting treatment, mental health experts said. They warned that

people with untreated depression _ about half of those who suffer from the

disease _ face an estimated 15 percent greater likelihood of death by suicide.

Dr. ph Glenmullen, a Harvard Medical School clinical instructor in

psychiatry and author of " Prozac Backlash, " said expanding the warnings wouldn't

scare off patients, but instead would allow them to make informed choices.

The FDA recently completed a review of 372 studies involving about 100,000

patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil.

When the results were analyzed by age, it became clear there was an elevated

though small and short-term risk for suicidal thoughts and behavior among adults

18 to 24, the FDA said in documents released ahead of Wednesday's meeting of its

psychopharmacologic drugs advisory committee.

The FDA's analysis of the multiple studies suggests an age-related shift in the

risk of suicidal thoughts and behavior associated with treatment with the drugs.

For instance, antidepressants seem to protect against suicidal thoughts and

behavior in adults 30 and older, with the effect most pronounced in patients

over 65.

The FDA said the increased risk could mean as many as 14 additional cases of

suicidal thoughts or behavior in every 1,000 children treated with

antidepressants. For adults 18 to 24, there could be four additional such cases

per 1,000.

In May, GlaxoKline and the FDA warned Paxil may raise the risk of suicidal

behavior in young adults and added that to the drug's label.

" Anytime suicide is involved it is a tragic outcome. It is one of the things

that keeps us motivated to search for better treatments because depression can

be a fatal illness, " GlaxoKline spokeswoman Anne Rhyne said.

[Guest guest]

http://www.cumberlink.com/articles/2006/12/13/ap/health/d8m06tg00.txt

FDA May Expand Antidepressant Warning

By ANDREW BRIDGES

WASHINGTON - Antidepressants increase the risk of suicidal behavior for people

up to age 24, the government said Wednesday. It plans new warning labels and

says users of all ages should be closely monitored.

The label change proposed Wednesday would expand a warning now on the

antidepressants that applies only to children and adolescents.

The Food and Drug Administration put forth its plan to update the drug labels at

a meeting of outside advisers on the issue. The changes also would include a

recommendation for careful monitoring, especially when patients are beginning

treatment.

Public reaction was split, with some saying the changes were overdue and others

arguing they could keep drugs from those who need them.

In emotional testimony illustrated at times by slides of family photos,

relatives of suicide victims pleaded for the new warnings.

Suzanne , shouting and in tears, goaded the panel to action, telling the

experts that her 40-year-old husband who had been taking Paxil shot himself.

" I wake up every morning thinking, 'Oh my God, he's dead. He is freaking dead.'

Do you wake up and think, 'How many people are going to die today because I am

doing nothing?' " asked.

Still, mental health experts worry that additional warnings could curtail use of

the drugs and ultimately do more harm than good.

Dr. Mann, a Columbia University psychiatrist, suggested simply replacing

the proposed expanded warnings with the recommendation that doctors more closely

monitor their patients.

" We can do more good by providing more treatment for depressed children and

adults, " Mann said.

The FDA proposed the changes after completing a review that found use of the

drugs may increase the risk of suicidal thoughts and behavior among young adults

18 to 24, as well as among younger patients.

Psychiatrists testified Wednesday that the 2004 addition of a warning for

children led to a falloff in antidepressant prescriptions being written for

patients under 18 _ and an increase in suicides in that age group.

Still, overall use of antidepressants continues to grow, with nearly 190 million

prescriptions dispensed in the United States last year, according to IMS Health,

a health care information company. That suggests doctors have placed more weight

on the long-term benefits of the drugs than on any short-term risks, said Dr.

Laughren, director of the FDA's division of psychiatry products.

Expanding the " black box " or other warnings on the drugs could dissuade patients

from seeking or starting treatment, mental health experts said. They warned that

people with untreated depression _ about half of those who suffer from the

disease _ face an estimated 15 percent greater likelihood of death by suicide.

Dr. ph Glenmullen, a Harvard Medical School clinical instructor in

psychiatry and author of " Prozac Backlash, " said expanding the warnings wouldn't

scare off patients, but instead would allow them to make informed choices.

The FDA recently completed a review of 372 studies involving about 100,000

patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil.

When the results were analyzed by age, it became clear there was an elevated

though small and short-term risk for suicidal thoughts and behavior among adults

18 to 24, the FDA said in documents released ahead of Wednesday's meeting of its

psychopharmacologic drugs advisory committee.

The FDA's analysis of the multiple studies suggests an age-related shift in the

risk of suicidal thoughts and behavior associated with treatment with the drugs.

For instance, antidepressants seem to protect against suicidal thoughts and

behavior in adults 30 and older, with the effect most pronounced in patients

over 65.

The FDA said the increased risk could mean as many as 14 additional cases of

suicidal thoughts or behavior in every 1,000 children treated with

antidepressants. For adults 18 to 24, there could be four additional such cases

per 1,000.

In May, GlaxoKline and the FDA warned Paxil may raise the risk of suicidal

behavior in young adults and added that to the drug's label.

" Anytime suicide is involved it is a tragic outcome. It is one of the things

that keeps us motivated to search for better treatments because depression can

be a fatal illness, " GlaxoKline spokeswoman Anne Rhyne said.