FDA Asks Antidepressant drug companies to add Cautions on labe

[Guest guest]

FDA Asks Antidepressant drug companies to add Cautions on labe

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and

full

disclosure http://www.ahrp.org

The FDA has " requested " drug companies to put prominent warnings on

the

labels of 10 antidepressant drugs, " to include stronger cautions and

warnings about the need to monitor patients for the worsening of

depression

and the emergence of suicidal ideation, regardless of the cause of

such

worsening. " The warnings apply to children and adults.

The FDA did not clearly spell out that it is the drugs that most

likely

trigger suicidal and aggressive behavior. In clinical trials these

high

risk

behaviors occurred in children taking the drugs, not those taking

placebo.

By failing to identify the reasonable evidence linking the drugs to

the

high

risk behavior, the FDA is shielding manufacturers from legal

liability.

Nevertheless, prescribing physicians will be on notice that these

drugs

are

not benign--as they had been led to believe. They will have a clue

that

antidepressants should not be prescribed like a panacea.

The FDA has given in to public pressure after compelling testimonies

of

grieving families at a public advisory committee hearing (February

2).

In

that sense this is a victory for those who have for years advocated

for

drug

warnings. FDA's advisory committee was persuaded by the credible

testimonies. The testimonies corroborated the analyses of independent

experts that found reasonable evidence linking antidepressants to

increased

risks of harm to self and others.

The FDA continued to deny a problem existed until the concealed,

unpublished

evidence uncovered in court proceedings reached the public arena. In

fact,

FDA's chief counsel filed an Amicus Curiae brief stating that Pfizer,

manufacturer of Zoloft (one of the antidepressants that will now

have to

carry a warning) the FDA would prohibit the company from putting a

warning

label about the potential suicide risk because that would be

" misbranding. "

The FDA has failed to provide leadership. FDA officials are passing

the

buck

and playing for time by turning the clinical trial data that was in

its

possession for over a decade to Columbia University for " re-

analysis. "

Why

did the FDA fail to do its own analysis over the years and report the

findings?

Conflict of interest is the major reason for the concealment of

evidence

not

favorable to drug manufacturers. Concealment of the evidence has led

to

unwarranted and risky prescribing of antidepressant drugs and has

resulted

in preventable suicides.

The public good will be served only when all clinical trial data is

publicly

available for independent analysis and validation. Columbia is one of

the

major stakeholders in psychiatric drug research and its faculty has

been

in

the forefront of publishing unsupportable " positive " reports that

misinformed doctors by stating that antidepressants were " safe and

effective " for children. What credibility will an analysis by

stakeholders

in the industry have?

Why does the FDA not accept the finding of its own independent

medical

expert who has analyzed the data? Dr. Mosholder analyzed the

data

and

corroborated the findings of Dr. Healy and the analysis of the

British

Medicine authority.

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare@a...

http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01283.html

FDA Talk Paper

T04-08

March 22, 2004

Media Inquiries: 301-827-6242

Consumer Inquiries: 888-INFO-FDA

FDA Issues Public Health Advisory on Cautions for Use of

Antidepressants

in

Adults and Children The Food and Drug Administration today issued a

Public

Health Advisory that provides further cautions to physicians, their

patients, and families and caregivers of patients about the need to

closely

monitor both adults and children with depression, especially at the

beginning of treatment, or when the doses are changed with either an

increase or decrease in the dose.

FDA has been closely reviewing the results of antidepressant studies

in

children, since June 2003, after an initial report on studies with

paroxetine (Paxil), and subsequent reports on studies of other drugs,

appeared to suggest an increased risk of suicidal thoughts and

actions

in

the children given antidepressants. There were no suicides in any of

the

trials. On close examination of the initial reports, it was unclear

whether

certain behaviors reported in these studies represented actual

suicide

attempts, or other self-injurious behavior that was not suicide-

related.

FDA has initiated a full review of these reported behaviors by

experts

in

such evaluation. However, it is not yet clear whether antidepressants

contribute to the emergence of suicidal thinking and behavior. The

agency is

advising clinicians, patients, families and caregivers of adults and

children that they should closely monitor all patients being placed

on

therapy with these drugs for worsening depression and suicidal

thinking,

which can occur during the early period of treatment. The agency is

also

advising that these patients be observed for certain behaviors that

are

known to be associated with these drugs, such as anxiety, agitation,

panic

attacks, insomnia, irritability, hostility, impulsivity, akathisia

(severe

restlessness), hypomania, and mania, and that physicians be

particularly

vigilant in patients who may have bipolar disorder.

FDA is asking manufacturers to change the labels of ten drugs to

include

stronger cautions and warnings about the need to monitor patients for

the

worsening of depression and the emergence of suicidal ideation,

regardless

of the cause of such worsening.

The drugs under review include bupropion, citalopram, fluoxetine,

fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline,

escitalopram

and venlafaxine. It should be noted that the only drug that has

received

approval for use in children with major depressive disorder is

fluoxetine

(Prozac). Several of these drugs are approved for the treatment of

obsessive-compulsive disorder in pediatric patients, i.e., sertraline

(Zoloft), fluoxetine (Prozac), and fluvoxamine (Luvox). Luvox is not

approved as an antidepressant in the United States.

These interim actions follow recommendations made by FDA's

Psychopharmacologic Drugs and Pediatric Subcommittee of the

Anti-Infective

Drugs Advisory Committees, which met on February 2, 2004. The

advisory

committee members advised FDA that the labeling should draw more

attention

to the need to monitor patients being treated with certain

antidepressants.

FDA has previously noted (in Public Health Advisory and a Talk Paper

T03-70

published Oct. 27, 2003) the possible finding of increased suicidal

thinking

or behavior, but emphasized that it was not clear that the drugs

caused

such

events and additional analyses were being done to allow FDA to seek

more

definitive answers.

The Public Health Advisory containing the new label warnings and

cautions is

available online at

http://www.fda.gov/cder/drug/antidepressants/default.htm.

Later this summer, FDA plans to update the Advisory Committees on the

results of the expert analyses and its own analyses of the pediatric

suicidality data.

[Guest guest]

Another version of this story:

http://www.msnbc.msn.com/id/4579108/

Gold

jonnygee@...

FDA Asks Antidepressant drug companies to add

Cautions on labe

FDA Asks Antidepressant drug companies to add Cautions on labe

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and

full

disclosure http://www.ahrp.org

The FDA has " requested " drug companies to put prominent warnings on

the

labels of 10 antidepressant drugs, " to include stronger cautions and

warnings about the need to monitor patients for the worsening of

depression

and the emergence of suicidal ideation, regardless of the cause of

such

worsening. " The warnings apply to children and adults.

The FDA did not clearly spell out that it is the drugs that most

likely

trigger suicidal and aggressive behavior. In clinical trials these

high

risk

behaviors occurred in children taking the drugs, not those taking

placebo.

By failing to identify the reasonable evidence linking the drugs to

the

high

risk behavior, the FDA is shielding manufacturers from legal

liability.

Nevertheless, prescribing physicians will be on notice that these

drugs

are

not benign--as they had been led to believe. They will have a clue

that

antidepressants should not be prescribed like a panacea.

The FDA has given in to public pressure after compelling testimonies

of

grieving families at a public advisory committee hearing (February

2).

In

that sense this is a victory for those who have for years advocated

for

drug

warnings. FDA's advisory committee was persuaded by the credible

testimonies. The testimonies corroborated the analyses of independent

experts that found reasonable evidence linking antidepressants to

increased

risks of harm to self and others.

The FDA continued to deny a problem existed until the concealed,

unpublished

evidence uncovered in court proceedings reached the public arena. In

fact,

FDA's chief counsel filed an Amicus Curiae brief stating that Pfizer,

manufacturer of Zoloft (one of the antidepressants that will now

have to

carry a warning) the FDA would prohibit the company from putting a

warning

label about the potential suicide risk because that would be

" misbranding. "

The FDA has failed to provide leadership. FDA officials are passing

the

buck

and playing for time by turning the clinical trial data that was in

its

possession for over a decade to Columbia University for " re-

analysis. "

Why

did the FDA fail to do its own analysis over the years and report the

findings?

Conflict of interest is the major reason for the concealment of

evidence

not

favorable to drug manufacturers. Concealment of the evidence has led

to

unwarranted and risky prescribing of antidepressant drugs and has

resulted

in preventable suicides.

The public good will be served only when all clinical trial data is

publicly

available for independent analysis and validation. Columbia is one of

the

major stakeholders in psychiatric drug research and its faculty has

been

in

the forefront of publishing unsupportable " positive " reports that

misinformed doctors by stating that antidepressants were " safe and

effective " for children. What credibility will an analysis by

stakeholders

in the industry have?

Why does the FDA not accept the finding of its own independent

medical

expert who has analyzed the data? Dr. Mosholder analyzed the

data

and

corroborated the findings of Dr. Healy and the analysis of the

British

Medicine authority.

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare@a...

http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01283.html

FDA Talk Paper

T04-08

March 22, 2004

Media Inquiries: 301-827-6242

Consumer Inquiries: 888-INFO-FDA

FDA Issues Public Health Advisory on Cautions for Use of

Antidepressants

in

Adults and Children The Food and Drug Administration today issued a

Public

Health Advisory that provides further cautions to physicians, their

patients, and families and caregivers of patients about the need to

closely

monitor both adults and children with depression, especially at the

beginning of treatment, or when the doses are changed with either an

increase or decrease in the dose.

FDA has been closely reviewing the results of antidepressant studies

in

children, since June 2003, after an initial report on studies with

paroxetine (Paxil), and subsequent reports on studies of other drugs,

appeared to suggest an increased risk of suicidal thoughts and

actions

in

the children given antidepressants. There were no suicides in any of

the

trials. On close examination of the initial reports, it was unclear

whether

certain behaviors reported in these studies represented actual

suicide

attempts, or other self-injurious behavior that was not suicide-

related.

FDA has initiated a full review of these reported behaviors by

experts

in

such evaluation. However, it is not yet clear whether antidepressants

contribute to the emergence of suicidal thinking and behavior. The

agency is

advising clinicians, patients, families and caregivers of adults and

children that they should closely monitor all patients being placed

on

therapy with these drugs for worsening depression and suicidal

thinking,

which can occur during the early period of treatment. The agency is

also

advising that these patients be observed for certain behaviors that

are

known to be associated with these drugs, such as anxiety, agitation,

panic

attacks, insomnia, irritability, hostility, impulsivity, akathisia

(severe

restlessness), hypomania, and mania, and that physicians be

particularly

vigilant in patients who may have bipolar disorder.

FDA is asking manufacturers to change the labels of ten drugs to

include

stronger cautions and warnings about the need to monitor patients for

the

worsening of depression and the emergence of suicidal ideation,

regardless

of the cause of such worsening.

The drugs under review include bupropion, citalopram, fluoxetine,

fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline,

escitalopram

and venlafaxine. It should be noted that the only drug that has

received

approval for use in children with major depressive disorder is

fluoxetine

(Prozac). Several of these drugs are approved for the treatment of

obsessive-compulsive disorder in pediatric patients, i.e., sertraline

(Zoloft), fluoxetine (Prozac), and fluvoxamine (Luvox). Luvox is not

approved as an antidepressant in the United States.

These interim actions follow recommendations made by FDA's

Psychopharmacologic Drugs and Pediatric Subcommittee of the

Anti-Infective

Drugs Advisory Committees, which met on February 2, 2004. The

advisory

committee members advised FDA that the labeling should draw more

attention

to the need to monitor patients being treated with certain

antidepressants.

FDA has previously noted (in Public Health Advisory and a Talk Paper

T03-70

published Oct. 27, 2003) the possible finding of increased suicidal

thinking

or behavior, but emphasized that it was not clear that the drugs

caused

such

events and additional analyses were being done to allow FDA to seek

more

definitive answers.

The Public Health Advisory containing the new label warnings and

cautions is

available online at

http://www.fda.gov/cder/drug/antidepressants/default.htm.

Later this summer, FDA plans to update the Advisory Committees on the

results of the expert analyses and its own analyses of the pediatric

suicidality data.

[Guest guest]

Another version of this story:

http://www.msnbc.msn.com/id/4579108/

Gold

jonnygee@...

FDA Asks Antidepressant drug companies to add

Cautions on labe

FDA Asks Antidepressant drug companies to add Cautions on labe

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and

full

disclosure http://www.ahrp.org

The FDA has " requested " drug companies to put prominent warnings on

the

labels of 10 antidepressant drugs, " to include stronger cautions and

warnings about the need to monitor patients for the worsening of

depression

and the emergence of suicidal ideation, regardless of the cause of

such

worsening. " The warnings apply to children and adults.

The FDA did not clearly spell out that it is the drugs that most

likely

trigger suicidal and aggressive behavior. In clinical trials these

high

risk

behaviors occurred in children taking the drugs, not those taking

placebo.

By failing to identify the reasonable evidence linking the drugs to

the

high

risk behavior, the FDA is shielding manufacturers from legal

liability.

Nevertheless, prescribing physicians will be on notice that these

drugs

are

not benign--as they had been led to believe. They will have a clue

that

antidepressants should not be prescribed like a panacea.

The FDA has given in to public pressure after compelling testimonies

of

grieving families at a public advisory committee hearing (February

2).

In

that sense this is a victory for those who have for years advocated

for

drug

warnings. FDA's advisory committee was persuaded by the credible

testimonies. The testimonies corroborated the analyses of independent

experts that found reasonable evidence linking antidepressants to

increased

risks of harm to self and others.

The FDA continued to deny a problem existed until the concealed,

unpublished

evidence uncovered in court proceedings reached the public arena. In

fact,

FDA's chief counsel filed an Amicus Curiae brief stating that Pfizer,

manufacturer of Zoloft (one of the antidepressants that will now

have to

carry a warning) the FDA would prohibit the company from putting a

warning

label about the potential suicide risk because that would be

" misbranding. "

The FDA has failed to provide leadership. FDA officials are passing

the

buck

and playing for time by turning the clinical trial data that was in

its

possession for over a decade to Columbia University for " re-

analysis. "

Why

did the FDA fail to do its own analysis over the years and report the

findings?

Conflict of interest is the major reason for the concealment of

evidence

not

favorable to drug manufacturers. Concealment of the evidence has led

to

unwarranted and risky prescribing of antidepressant drugs and has

resulted

in preventable suicides.

The public good will be served only when all clinical trial data is

publicly

available for independent analysis and validation. Columbia is one of

the

major stakeholders in psychiatric drug research and its faculty has

been

in

the forefront of publishing unsupportable " positive " reports that

misinformed doctors by stating that antidepressants were " safe and

effective " for children. What credibility will an analysis by

stakeholders

in the industry have?

Why does the FDA not accept the finding of its own independent

medical

expert who has analyzed the data? Dr. Mosholder analyzed the

data

and

corroborated the findings of Dr. Healy and the analysis of the

British

Medicine authority.

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare@a...

http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01283.html

FDA Talk Paper

T04-08

March 22, 2004

Media Inquiries: 301-827-6242

Consumer Inquiries: 888-INFO-FDA

FDA Issues Public Health Advisory on Cautions for Use of

Antidepressants

in

Adults and Children The Food and Drug Administration today issued a

Public

Health Advisory that provides further cautions to physicians, their

patients, and families and caregivers of patients about the need to

closely

monitor both adults and children with depression, especially at the

beginning of treatment, or when the doses are changed with either an

increase or decrease in the dose.

FDA has been closely reviewing the results of antidepressant studies

in

children, since June 2003, after an initial report on studies with

paroxetine (Paxil), and subsequent reports on studies of other drugs,

appeared to suggest an increased risk of suicidal thoughts and

actions

in

the children given antidepressants. There were no suicides in any of

the

trials. On close examination of the initial reports, it was unclear

whether

certain behaviors reported in these studies represented actual

suicide

attempts, or other self-injurious behavior that was not suicide-

related.

FDA has initiated a full review of these reported behaviors by

experts

in

such evaluation. However, it is not yet clear whether antidepressants

contribute to the emergence of suicidal thinking and behavior. The

agency is

advising clinicians, patients, families and caregivers of adults and

children that they should closely monitor all patients being placed

on

therapy with these drugs for worsening depression and suicidal

thinking,

which can occur during the early period of treatment. The agency is

also

advising that these patients be observed for certain behaviors that

are

known to be associated with these drugs, such as anxiety, agitation,

panic

attacks, insomnia, irritability, hostility, impulsivity, akathisia

(severe

restlessness), hypomania, and mania, and that physicians be

particularly

vigilant in patients who may have bipolar disorder.

FDA is asking manufacturers to change the labels of ten drugs to

include

stronger cautions and warnings about the need to monitor patients for

the

worsening of depression and the emergence of suicidal ideation,

regardless

of the cause of such worsening.

The drugs under review include bupropion, citalopram, fluoxetine,

fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline,

escitalopram

and venlafaxine. It should be noted that the only drug that has

received

approval for use in children with major depressive disorder is

fluoxetine

(Prozac). Several of these drugs are approved for the treatment of

obsessive-compulsive disorder in pediatric patients, i.e., sertraline

(Zoloft), fluoxetine (Prozac), and fluvoxamine (Luvox). Luvox is not

approved as an antidepressant in the United States.

These interim actions follow recommendations made by FDA's

Psychopharmacologic Drugs and Pediatric Subcommittee of the

Anti-Infective

Drugs Advisory Committees, which met on February 2, 2004. The

advisory

committee members advised FDA that the labeling should draw more

attention

to the need to monitor patients being treated with certain

antidepressants.

FDA has previously noted (in Public Health Advisory and a Talk Paper

T03-70

published Oct. 27, 2003) the possible finding of increased suicidal

thinking

or behavior, but emphasized that it was not clear that the drugs

caused

such

events and additional analyses were being done to allow FDA to seek

more

definitive answers.

The Public Health Advisory containing the new label warnings and

cautions is

available online at

http://www.fda.gov/cder/drug/antidepressants/default.htm.

Later this summer, FDA plans to update the Advisory Committees on the

results of the expert analyses and its own analyses of the pediatric

suicidality data.