Re: Duckworth Medical Director of NAMI Comments on FDA black box warning

[Guest guest]

Hey, if these drugs are so important to the treatment of children and

adolescents diagnosed with depression, how come they aren't approved

for use by children and adolscents? How come the scientific studies

required by the FDA don't prove they are effective? Are these people

-- NAMI and the FDA -- pushing off label use of these drugs? I

thought that was illegal? It must certainly be unethical.

>

>

>

> NAMI Comments on FDA Announcement on New Warning Labels for

> Antidepressants Used With Children

> Friday October 15, 3:07 pm ET

>

>

> NAMI Medical Director Duckworth, a board certified child

> psychiatrist, today issued the following statement in response to

> the FDA announcement on new warning labels for antidepressants used

> with children:

>

>

>

> Providing both doctors and parents with complete information

> represents sound clinical practice. Discussion of benefits and risks

> in prescribing any medication or course of treatment is essential.

>

> Close monitoring is appropriate. So too is the need for a clear

> warning that depression and other psychiatric disorders can have

> significant consequences, including suicidality, if not

> appropriately treated.

>

> The FDA's press release claims that the " new warning language

> recognizes this need " while advising close monitoring as a way to

> manage the risk. However, the FDA's recognition of the risk is NOT

> included in the actual black box warning language nor clearly stated

> in other labeling changes. This is a serious omission. Untreated

> mental illness poses a very real risk of suicide. We know that 80

> percent of children today with mental illnesses are not getting any

> treatment. Suicide in fact is the 3rd leading cause of death among

> young people ages 15 to 24, constituting an even broader public

> health crisis.

>

> The new labeling also does not recognize that antidepressants

> combined with psychotherapy represents the most effective course of

> treatment.

>

> The risk now is that the FDA's incomplete warning language may

> simply discourage pediatricians from prescribing antidepressants at

> all, at a time when there is a severe shortage of child

> psychiatrists nationwide.

>

> Greater education and training of doctors will be needed, besides

> greater education and dialogue with parents. Otherwise, the risk of

> unintended consequences may end up greater than the risks behind the

> FDA's action.

>

>

>

>

>

> Source: NAMI

[Guest guest]

Hey, if these drugs are so important to the treatment of children and

adolescents diagnosed with depression, how come they aren't approved

for use by children and adolscents? How come the scientific studies

required by the FDA don't prove they are effective? Are these people

-- NAMI and the FDA -- pushing off label use of these drugs? I

thought that was illegal? It must certainly be unethical.

>

>

>

> NAMI Comments on FDA Announcement on New Warning Labels for

> Antidepressants Used With Children

> Friday October 15, 3:07 pm ET

>

>

> NAMI Medical Director Duckworth, a board certified child

> psychiatrist, today issued the following statement in response to

> the FDA announcement on new warning labels for antidepressants used

> with children:

>

>

>

> Providing both doctors and parents with complete information

> represents sound clinical practice. Discussion of benefits and risks

> in prescribing any medication or course of treatment is essential.

>

> Close monitoring is appropriate. So too is the need for a clear

> warning that depression and other psychiatric disorders can have

> significant consequences, including suicidality, if not

> appropriately treated.

>

> The FDA's press release claims that the " new warning language

> recognizes this need " while advising close monitoring as a way to

> manage the risk. However, the FDA's recognition of the risk is NOT

> included in the actual black box warning language nor clearly stated

> in other labeling changes. This is a serious omission. Untreated

> mental illness poses a very real risk of suicide. We know that 80

> percent of children today with mental illnesses are not getting any

> treatment. Suicide in fact is the 3rd leading cause of death among

> young people ages 15 to 24, constituting an even broader public

> health crisis.

>

> The new labeling also does not recognize that antidepressants

> combined with psychotherapy represents the most effective course of

> treatment.

>

> The risk now is that the FDA's incomplete warning language may

> simply discourage pediatricians from prescribing antidepressants at

> all, at a time when there is a severe shortage of child

> psychiatrists nationwide.

>

> Greater education and training of doctors will be needed, besides

> greater education and dialogue with parents. Otherwise, the risk of

> unintended consequences may end up greater than the risks behind the

> FDA's action.

>

>

>

>

>

> Source: NAMI

[Guest guest]

In Talking Back to Prozac ( I know it is an old book by now), Dr. Breggin

states something to the effect that after a search of the literature, he found

that anxiety, not depression, is the biggest cause of suicide. This is re all

the talk these days, as by the psychiatrist below, referring to depression as a

suicide risk, if left " untreated. " gertie

Duckworth Medical Director of NAMI Comments

on FDA black box warning

NAMI Comments on FDA Announcement on New Warning Labels for

Antidepressants Used With Children

Friday October 15, 3:07 pm ET

NAMI Medical Director Duckworth, a board certified child

psychiatrist, today issued the following statement in response to

the FDA announcement on new warning labels for antidepressants used

with children:

Providing both doctors and parents with complete information

represents sound clinical practice. Discussion of benefits and risks

in prescribing any medication or course of treatment is essential.

Close monitoring is appropriate. So too is the need for a clear

warning that depression and other psychiatric disorders can have

significant consequences, including suicidality, if not

appropriately treated.

The FDA's press release claims that the " new warning language

recognizes this need " while advising close monitoring as a way to

manage the risk. However, the FDA's recognition of the risk is NOT

included in the actual black box warning language nor clearly stated

in other labeling changes. This is a serious omission. Untreated

mental illness poses a very real risk of suicide. We know that 80

percent of children today with mental illnesses are not getting any

treatment. Suicide in fact is the 3rd leading cause of death among

young people ages 15 to 24, constituting an even broader public

health crisis.

The new labeling also does not recognize that antidepressants

combined with psychotherapy represents the most effective course of

treatment.

The risk now is that the FDA's incomplete warning language may

simply discourage pediatricians from prescribing antidepressants at

all, at a time when there is a severe shortage of child

psychiatrists nationwide.

Greater education and training of doctors will be needed, besides

greater education and dialogue with parents. Otherwise, the risk of

unintended consequences may end up greater than the risks behind the

FDA's action.

Source: NAMI

[Guest guest]

In Talking Back to Prozac ( I know it is an old book by now), Dr. Breggin

states something to the effect that after a search of the literature, he found

that anxiety, not depression, is the biggest cause of suicide. This is re all

the talk these days, as by the psychiatrist below, referring to depression as a

suicide risk, if left " untreated. " gertie

Duckworth Medical Director of NAMI Comments

on FDA black box warning

NAMI Comments on FDA Announcement on New Warning Labels for

Antidepressants Used With Children

Friday October 15, 3:07 pm ET

NAMI Medical Director Duckworth, a board certified child

psychiatrist, today issued the following statement in response to

the FDA announcement on new warning labels for antidepressants used

with children:

Providing both doctors and parents with complete information

represents sound clinical practice. Discussion of benefits and risks

in prescribing any medication or course of treatment is essential.

Close monitoring is appropriate. So too is the need for a clear

warning that depression and other psychiatric disorders can have

significant consequences, including suicidality, if not

appropriately treated.

The FDA's press release claims that the " new warning language

recognizes this need " while advising close monitoring as a way to

manage the risk. However, the FDA's recognition of the risk is NOT

included in the actual black box warning language nor clearly stated

in other labeling changes. This is a serious omission. Untreated

mental illness poses a very real risk of suicide. We know that 80

percent of children today with mental illnesses are not getting any

treatment. Suicide in fact is the 3rd leading cause of death among

young people ages 15 to 24, constituting an even broader public

health crisis.

The new labeling also does not recognize that antidepressants

combined with psychotherapy represents the most effective course of

treatment.

The risk now is that the FDA's incomplete warning language may

simply discourage pediatricians from prescribing antidepressants at

all, at a time when there is a severe shortage of child

psychiatrists nationwide.

Greater education and training of doctors will be needed, besides

greater education and dialogue with parents. Otherwise, the risk of

unintended consequences may end up greater than the risks behind the

FDA's action.

Source: NAMI