Use of SSRIs in children and adolescents ...Europe latest warnings 10/12/2004

[Guest guest]

" Therefore the CHMP considers that there is a need to warn

physicians and parents that there is a signal of an increase in

suicidal behaviour, including suicide attempts and suicidal ideation

and/or related behaviour like self-harm, hostility and mood lability

in children and adolescents treated with SSRIs and SNRIs. There were

no reports of deaths due to suicide in the clinical trials reviewed

in children and adolescents.............. "

ANNEX II – Use of SSRIs in children and adolescents

http://www.network54.com/Forum/message?

forumid=281849 & messageid=1102685964

Following the Article 31 referral on Paroxetine, the European

Commission requested the EMEA Scientific Committee, the Committee

for Medicinal Products for Human Use (CHMP) to advise whether there

was any public health concern in relation to the safe use of SSRIs

in children and adolescents.

The CHMP evaluation focussed on the following products: Atomoxetine,

Citalopram, Duloxetine, Escitalopram, Fluoxetine, Fluvoxamine,

Mianserine, Milnacipran, Mirtazapine, Paroxetine, Reboxetine,

Sertraline and Venlafaxine.

The CHMP reviewed the data available to national competent

authorities for these compounds in children and adolescents. This

included:

& #65463; 28 short-term placebo controlled randomised clinical trials

(RCTs)

that were submitted to the EU competent authorities (15 in Major

Depressive Disorder (MDD), 7 in anxiety disorders and 6 in Attention

Deficit/Hyperactivity Disorder (ADHD)). In total more than 5000

patients were evaluated.

& #65463; 8 additional RCTs that were published in the medical

literature.

& #65463; Several observational studies (based on the UK General

Practice

Research Database (GPRD)

and ecological studies).

& #65463; Active control trials and uncontrolled extension data were

not

taken into account as they do not provide a comparison with placebo.

The CHMP also set up an ad-hoc expert group which included child

psychiatrists in order to advise the

Committee on this matter.

The studies that were examined indicate the following:

& #65463; There were no reports of deaths due to suicide in any of the

clinical trials in children and adolescents.

& #65463; MDD studies showed consistent increase in the risk of

suicidal

related behaviour (such as suicide attempts and suicidal thoughts)

in all antidepressants.

& #65463; The signal in anxiety disorders studies was less strong but

still

present.

& #65463; ADHD studies did not show increased suicidal behaviour.

& #65463; For each compound reviewed where sufficient data were

available

there was a signal of suicidal related behaviour, self-harm or

hostility. These concerns cannot be excluded for those compounds

where data on children and adolescents were limited.

& #65463; From the GPRD studies there were some apparent differences

between

products. However, the evidence from the randomised clinical trials

did not show such a difference.

Therefore the CHMP considers that there is a need to warn physicians

and parents that there is a signal of an increase in suicidal

behaviour, including suicide attempts and suicidal ideation and/or

related behaviour like self-harm, hostility and mood lability in

children and adolescents treated with SSRIs and SNRIs. There were no

reports of deaths due to suicide in the clinical trials reviewed in

children and adolescents.

[Guest guest]

" Therefore the CHMP considers that there is a need to warn

physicians and parents that there is a signal of an increase in

suicidal behaviour, including suicide attempts and suicidal ideation

and/or related behaviour like self-harm, hostility and mood lability

in children and adolescents treated with SSRIs and SNRIs. There were

no reports of deaths due to suicide in the clinical trials reviewed

in children and adolescents.............. "

ANNEX II – Use of SSRIs in children and adolescents

http://www.network54.com/Forum/message?

forumid=281849 & messageid=1102685964

Following the Article 31 referral on Paroxetine, the European

Commission requested the EMEA Scientific Committee, the Committee

for Medicinal Products for Human Use (CHMP) to advise whether there

was any public health concern in relation to the safe use of SSRIs

in children and adolescents.

The CHMP evaluation focussed on the following products: Atomoxetine,

Citalopram, Duloxetine, Escitalopram, Fluoxetine, Fluvoxamine,

Mianserine, Milnacipran, Mirtazapine, Paroxetine, Reboxetine,

Sertraline and Venlafaxine.

The CHMP reviewed the data available to national competent

authorities for these compounds in children and adolescents. This

included:

& #65463; 28 short-term placebo controlled randomised clinical trials

(RCTs)

that were submitted to the EU competent authorities (15 in Major

Depressive Disorder (MDD), 7 in anxiety disorders and 6 in Attention

Deficit/Hyperactivity Disorder (ADHD)). In total more than 5000

patients were evaluated.

& #65463; 8 additional RCTs that were published in the medical

literature.

& #65463; Several observational studies (based on the UK General

Practice

Research Database (GPRD)

and ecological studies).

& #65463; Active control trials and uncontrolled extension data were

not

taken into account as they do not provide a comparison with placebo.

The CHMP also set up an ad-hoc expert group which included child

psychiatrists in order to advise the

Committee on this matter.

The studies that were examined indicate the following:

& #65463; There were no reports of deaths due to suicide in any of the

clinical trials in children and adolescents.

& #65463; MDD studies showed consistent increase in the risk of

suicidal

related behaviour (such as suicide attempts and suicidal thoughts)

in all antidepressants.

& #65463; The signal in anxiety disorders studies was less strong but

still

present.

& #65463; ADHD studies did not show increased suicidal behaviour.

& #65463; For each compound reviewed where sufficient data were

available

there was a signal of suicidal related behaviour, self-harm or

hostility. These concerns cannot be excluded for those compounds

where data on children and adolescents were limited.

& #65463; From the GPRD studies there were some apparent differences

between

products. However, the evidence from the randomised clinical trials

did not show such a difference.

Therefore the CHMP considers that there is a need to warn physicians

and parents that there is a signal of an increase in suicidal

behaviour, including suicide attempts and suicidal ideation and/or

related behaviour like self-harm, hostility and mood lability in

children and adolescents treated with SSRIs and SNRIs. There were no

reports of deaths due to suicide in the clinical trials reviewed in

children and adolescents.

[Guest guest]

" Therefore the CHMP considers that there is a need to warn

physicians and parents that there is a signal of an increase in

suicidal behaviour, including suicide attempts and suicidal ideation

and/or related behaviour like self-harm, hostility and mood lability

in children and adolescents treated with SSRIs and SNRIs. There were

no reports of deaths due to suicide in the clinical trials reviewed

in children and adolescents.............. "

ANNEX II – Use of SSRIs in children and adolescents

http://www.network54.com/Forum/message?

forumid=281849 & messageid=1102685964

Following the Article 31 referral on Paroxetine, the European

Commission requested the EMEA Scientific Committee, the Committee

for Medicinal Products for Human Use (CHMP) to advise whether there

was any public health concern in relation to the safe use of SSRIs

in children and adolescents.

The CHMP evaluation focussed on the following products: Atomoxetine,

Citalopram, Duloxetine, Escitalopram, Fluoxetine, Fluvoxamine,

Mianserine, Milnacipran, Mirtazapine, Paroxetine, Reboxetine,

Sertraline and Venlafaxine.

The CHMP reviewed the data available to national competent

authorities for these compounds in children and adolescents. This

included:

& #65463; 28 short-term placebo controlled randomised clinical trials

(RCTs)

that were submitted to the EU competent authorities (15 in Major

Depressive Disorder (MDD), 7 in anxiety disorders and 6 in Attention

Deficit/Hyperactivity Disorder (ADHD)). In total more than 5000

patients were evaluated.

& #65463; 8 additional RCTs that were published in the medical

literature.

& #65463; Several observational studies (based on the UK General

Practice

Research Database (GPRD)

and ecological studies).

& #65463; Active control trials and uncontrolled extension data were

not

taken into account as they do not provide a comparison with placebo.

The CHMP also set up an ad-hoc expert group which included child

psychiatrists in order to advise the

Committee on this matter.

The studies that were examined indicate the following:

& #65463; There were no reports of deaths due to suicide in any of the

clinical trials in children and adolescents.

& #65463; MDD studies showed consistent increase in the risk of

suicidal

related behaviour (such as suicide attempts and suicidal thoughts)

in all antidepressants.

& #65463; The signal in anxiety disorders studies was less strong but

still

present.

& #65463; ADHD studies did not show increased suicidal behaviour.

& #65463; For each compound reviewed where sufficient data were

available

there was a signal of suicidal related behaviour, self-harm or

hostility. These concerns cannot be excluded for those compounds

where data on children and adolescents were limited.

& #65463; From the GPRD studies there were some apparent differences

between

products. However, the evidence from the randomised clinical trials

did not show such a difference.

Therefore the CHMP considers that there is a need to warn physicians

and parents that there is a signal of an increase in suicidal

behaviour, including suicide attempts and suicidal ideation and/or

related behaviour like self-harm, hostility and mood lability in

children and adolescents treated with SSRIs and SNRIs. There were no

reports of deaths due to suicide in the clinical trials reviewed in

children and adolescents.

[Guest guest]

" Therefore the CHMP considers that there is a need to warn

physicians and parents that there is a signal of an increase in

suicidal behaviour, including suicide attempts and suicidal ideation

and/or related behaviour like self-harm, hostility and mood lability

in children and adolescents treated with SSRIs and SNRIs. There were

no reports of deaths due to suicide in the clinical trials reviewed

in children and adolescents.............. "

ANNEX II – Use of SSRIs in children and adolescents

http://www.network54.com/Forum/message?

forumid=281849 & messageid=1102685964

Following the Article 31 referral on Paroxetine, the European

Commission requested the EMEA Scientific Committee, the Committee

for Medicinal Products for Human Use (CHMP) to advise whether there

was any public health concern in relation to the safe use of SSRIs

in children and adolescents.

The CHMP evaluation focussed on the following products: Atomoxetine,

Citalopram, Duloxetine, Escitalopram, Fluoxetine, Fluvoxamine,

Mianserine, Milnacipran, Mirtazapine, Paroxetine, Reboxetine,

Sertraline and Venlafaxine.

The CHMP reviewed the data available to national competent

authorities for these compounds in children and adolescents. This

included:

& #65463; 28 short-term placebo controlled randomised clinical trials

(RCTs)

that were submitted to the EU competent authorities (15 in Major

Depressive Disorder (MDD), 7 in anxiety disorders and 6 in Attention

Deficit/Hyperactivity Disorder (ADHD)). In total more than 5000

patients were evaluated.

& #65463; 8 additional RCTs that were published in the medical

literature.

& #65463; Several observational studies (based on the UK General

Practice

Research Database (GPRD)

and ecological studies).

& #65463; Active control trials and uncontrolled extension data were

not

taken into account as they do not provide a comparison with placebo.

The CHMP also set up an ad-hoc expert group which included child

psychiatrists in order to advise the

Committee on this matter.

The studies that were examined indicate the following:

& #65463; There were no reports of deaths due to suicide in any of the

clinical trials in children and adolescents.

& #65463; MDD studies showed consistent increase in the risk of

suicidal

related behaviour (such as suicide attempts and suicidal thoughts)

in all antidepressants.

& #65463; The signal in anxiety disorders studies was less strong but

still

present.

& #65463; ADHD studies did not show increased suicidal behaviour.

& #65463; For each compound reviewed where sufficient data were

available

there was a signal of suicidal related behaviour, self-harm or

hostility. These concerns cannot be excluded for those compounds

where data on children and adolescents were limited.

& #65463; From the GPRD studies there were some apparent differences

between

products. However, the evidence from the randomised clinical trials

did not show such a difference.

Therefore the CHMP considers that there is a need to warn physicians

and parents that there is a signal of an increase in suicidal

behaviour, including suicide attempts and suicidal ideation and/or

related behaviour like self-harm, hostility and mood lability in

children and adolescents treated with SSRIs and SNRIs. There were no

reports of deaths due to suicide in the clinical trials reviewed in

children and adolescents.