Breaking: Joe Barton blasts FDA

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http://story.news./news?tmpl=story & cid=571 & ncid=1422 & e=4 & u=/nm/20040923\

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Lawmaker Blasts FDA Over Antidepressants Risk

1 hour, 40 minutes ago Add Health - Reuters to My

By Richwine

WASHINGTON (Reuters) - U.S. Food and Drug Administration staff first

questioned the possibility of a link between antidepressant use and suicidal

behavior in youth as far back as eight years ago, a senior U.S. lawmaker

charged on Thursday.

Rep. Joe Barton, chairman of the House Energy and Commerce Committee, said

one FDA medical reviewer raised the question of whether Pfizer Inc.'s Zoloft

had increased the risk of suicidal behavior in pediatric clinical trials in

a 1996 review.

Barton and other lawmakers criticized the agency's handling of an

investigation of the connection between widely prescribed antidepressants

and suicidal behavior in children and teens.

" The fact that children taking antidepressants were experiencing psychiatric

adverse events at greater rates than adults was known at the agency as far

back as 1996 and 1997, " Barton, a Texas Republican, said at a hearing of the

oversight and investigations subcommittee.

" I want to know: what did the agency do to respond to these concerns? "

Barton said.

Recent questions about youth antidepressant use began in May 2003 when

another FDA reviewer raised concerns that the drugs might increase the

chances of suicidal acts. But top agency officials did not publicly confirm

a link until last week.

Dr. Temple, director of the FDA's Office of Medical Policy, defended

the agency's handling of the controversy. He said data were unclear and

officials wanted to be certain of the risks before warning doctors and the

public.

" The agency realizes its responsibility to the public to find the right

answer to this question, " Temple said in remarks prepared for delivery at

the hearing.

For some patients, the drugs can be life-saving by relieving depression, a

serious mental illness that itself raises the risk of suicide. Many

psychiatrists believe the drop in teen suicides in recent years is linked to

the widespread use of antidepressants such as Prozac, Zoloft and Paxil.

The committee was scheduled to hear from Dr. Mosholder, the FDA

reviewer who told officials months ago he felt the drugs could make youth

suicide-prone. His supervisors disagreed and kept him from presenting his

analysis at a public advisory committee meeting in February.

The FDA now is drafting new warnings for all antidepressants about the

possibility of suicidal thoughts and actions among youth who take the drugs.

A panel of outside experts has recommended the drug labels highlight the

risk in a " black box, " the strongest type of warning for prescription drugs.

An FDA analysis estimated 2 percent to 3 percent of children and teens who

take antidepressants might have an elevated risk for suicidal behavior. But

no suicides occurred in studies of more than 4,000 children as young as six.

Antidepressants include Eli Lilly and Co.'s Prozac, Pfizer's Zoloft,

GlaxoKline Plc's Paxil, Forest Laboratories Inc.'s Celexa and Wyeth's

Effexor. Prozac also is sold under the generic name fluoxetine.

[Guest guest]

http://story.news./news?tmpl=story & cid=571 & ncid=1422 & e=4 & u=/nm/20040923\

/hl_nm/health_antidepressants_dc

Lawmaker Blasts FDA Over Antidepressants Risk

1 hour, 40 minutes ago Add Health - Reuters to My

By Richwine

WASHINGTON (Reuters) - U.S. Food and Drug Administration staff first

questioned the possibility of a link between antidepressant use and suicidal

behavior in youth as far back as eight years ago, a senior U.S. lawmaker

charged on Thursday.

Rep. Joe Barton, chairman of the House Energy and Commerce Committee, said

one FDA medical reviewer raised the question of whether Pfizer Inc.'s Zoloft

had increased the risk of suicidal behavior in pediatric clinical trials in

a 1996 review.

Barton and other lawmakers criticized the agency's handling of an

investigation of the connection between widely prescribed antidepressants

and suicidal behavior in children and teens.

" The fact that children taking antidepressants were experiencing psychiatric

adverse events at greater rates than adults was known at the agency as far

back as 1996 and 1997, " Barton, a Texas Republican, said at a hearing of the

oversight and investigations subcommittee.

" I want to know: what did the agency do to respond to these concerns? "

Barton said.

Recent questions about youth antidepressant use began in May 2003 when

another FDA reviewer raised concerns that the drugs might increase the

chances of suicidal acts. But top agency officials did not publicly confirm

a link until last week.

Dr. Temple, director of the FDA's Office of Medical Policy, defended

the agency's handling of the controversy. He said data were unclear and

officials wanted to be certain of the risks before warning doctors and the

public.

" The agency realizes its responsibility to the public to find the right

answer to this question, " Temple said in remarks prepared for delivery at

the hearing.

For some patients, the drugs can be life-saving by relieving depression, a

serious mental illness that itself raises the risk of suicide. Many

psychiatrists believe the drop in teen suicides in recent years is linked to

the widespread use of antidepressants such as Prozac, Zoloft and Paxil.

The committee was scheduled to hear from Dr. Mosholder, the FDA

reviewer who told officials months ago he felt the drugs could make youth

suicide-prone. His supervisors disagreed and kept him from presenting his

analysis at a public advisory committee meeting in February.

The FDA now is drafting new warnings for all antidepressants about the

possibility of suicidal thoughts and actions among youth who take the drugs.

A panel of outside experts has recommended the drug labels highlight the

risk in a " black box, " the strongest type of warning for prescription drugs.

An FDA analysis estimated 2 percent to 3 percent of children and teens who

take antidepressants might have an elevated risk for suicidal behavior. But

no suicides occurred in studies of more than 4,000 children as young as six.

Antidepressants include Eli Lilly and Co.'s Prozac, Pfizer's Zoloft,

GlaxoKline Plc's Paxil, Forest Laboratories Inc.'s Celexa and Wyeth's

Effexor. Prozac also is sold under the generic name fluoxetine.

[Guest guest]

http://story.news./news?tmpl=story & cid=571 & ncid=1422 & e=4 & u=/nm/20040923\

/hl_nm/health_antidepressants_dc

Lawmaker Blasts FDA Over Antidepressants Risk

1 hour, 40 minutes ago Add Health - Reuters to My

By Richwine

WASHINGTON (Reuters) - U.S. Food and Drug Administration staff first

questioned the possibility of a link between antidepressant use and suicidal

behavior in youth as far back as eight years ago, a senior U.S. lawmaker

charged on Thursday.

Rep. Joe Barton, chairman of the House Energy and Commerce Committee, said

one FDA medical reviewer raised the question of whether Pfizer Inc.'s Zoloft

had increased the risk of suicidal behavior in pediatric clinical trials in

a 1996 review.

Barton and other lawmakers criticized the agency's handling of an

investigation of the connection between widely prescribed antidepressants

and suicidal behavior in children and teens.

" The fact that children taking antidepressants were experiencing psychiatric

adverse events at greater rates than adults was known at the agency as far

back as 1996 and 1997, " Barton, a Texas Republican, said at a hearing of the

oversight and investigations subcommittee.

" I want to know: what did the agency do to respond to these concerns? "

Barton said.

Recent questions about youth antidepressant use began in May 2003 when

another FDA reviewer raised concerns that the drugs might increase the

chances of suicidal acts. But top agency officials did not publicly confirm

a link until last week.

Dr. Temple, director of the FDA's Office of Medical Policy, defended

the agency's handling of the controversy. He said data were unclear and

officials wanted to be certain of the risks before warning doctors and the

public.

" The agency realizes its responsibility to the public to find the right

answer to this question, " Temple said in remarks prepared for delivery at

the hearing.

For some patients, the drugs can be life-saving by relieving depression, a

serious mental illness that itself raises the risk of suicide. Many

psychiatrists believe the drop in teen suicides in recent years is linked to

the widespread use of antidepressants such as Prozac, Zoloft and Paxil.

The committee was scheduled to hear from Dr. Mosholder, the FDA

reviewer who told officials months ago he felt the drugs could make youth

suicide-prone. His supervisors disagreed and kept him from presenting his

analysis at a public advisory committee meeting in February.

The FDA now is drafting new warnings for all antidepressants about the

possibility of suicidal thoughts and actions among youth who take the drugs.

A panel of outside experts has recommended the drug labels highlight the

risk in a " black box, " the strongest type of warning for prescription drugs.

An FDA analysis estimated 2 percent to 3 percent of children and teens who

take antidepressants might have an elevated risk for suicidal behavior. But

no suicides occurred in studies of more than 4,000 children as young as six.

Antidepressants include Eli Lilly and Co.'s Prozac, Pfizer's Zoloft,

GlaxoKline Plc's Paxil, Forest Laboratories Inc.'s Celexa and Wyeth's

Effexor. Prozac also is sold under the generic name fluoxetine.

[Guest guest]

http://story.news./news?tmpl=story & cid=571 & ncid=1422 & e=4 & u=/nm/20040923\

/hl_nm/health_antidepressants_dc

Lawmaker Blasts FDA Over Antidepressants Risk

1 hour, 40 minutes ago Add Health - Reuters to My

By Richwine

WASHINGTON (Reuters) - U.S. Food and Drug Administration staff first

questioned the possibility of a link between antidepressant use and suicidal

behavior in youth as far back as eight years ago, a senior U.S. lawmaker

charged on Thursday.

Rep. Joe Barton, chairman of the House Energy and Commerce Committee, said

one FDA medical reviewer raised the question of whether Pfizer Inc.'s Zoloft

had increased the risk of suicidal behavior in pediatric clinical trials in

a 1996 review.

Barton and other lawmakers criticized the agency's handling of an

investigation of the connection between widely prescribed antidepressants

and suicidal behavior in children and teens.

" The fact that children taking antidepressants were experiencing psychiatric

adverse events at greater rates than adults was known at the agency as far

back as 1996 and 1997, " Barton, a Texas Republican, said at a hearing of the

oversight and investigations subcommittee.

" I want to know: what did the agency do to respond to these concerns? "

Barton said.

Recent questions about youth antidepressant use began in May 2003 when

another FDA reviewer raised concerns that the drugs might increase the

chances of suicidal acts. But top agency officials did not publicly confirm

a link until last week.

Dr. Temple, director of the FDA's Office of Medical Policy, defended

the agency's handling of the controversy. He said data were unclear and

officials wanted to be certain of the risks before warning doctors and the

public.

" The agency realizes its responsibility to the public to find the right

answer to this question, " Temple said in remarks prepared for delivery at

the hearing.

For some patients, the drugs can be life-saving by relieving depression, a

serious mental illness that itself raises the risk of suicide. Many

psychiatrists believe the drop in teen suicides in recent years is linked to

the widespread use of antidepressants such as Prozac, Zoloft and Paxil.

The committee was scheduled to hear from Dr. Mosholder, the FDA

reviewer who told officials months ago he felt the drugs could make youth

suicide-prone. His supervisors disagreed and kept him from presenting his

analysis at a public advisory committee meeting in February.

The FDA now is drafting new warnings for all antidepressants about the

possibility of suicidal thoughts and actions among youth who take the drugs.

A panel of outside experts has recommended the drug labels highlight the

risk in a " black box, " the strongest type of warning for prescription drugs.

An FDA analysis estimated 2 percent to 3 percent of children and teens who

take antidepressants might have an elevated risk for suicidal behavior. But

no suicides occurred in studies of more than 4,000 children as young as six.

Antidepressants include Eli Lilly and Co.'s Prozac, Pfizer's Zoloft,

GlaxoKline Plc's Paxil, Forest Laboratories Inc.'s Celexa and Wyeth's

Effexor. Prozac also is sold under the generic name fluoxetine.