paroxetine NOT to be used in children and adolescents .... Europe

[Guest guest]

: A warning to reflect that paroxetine should not be used in

children and adolescents. In the EU paroxetine is not authorised for

use in this population. Data from clinical trials raised concerns

regarding suicidal behaviour and hostility. In addition, data from

clinical trials have not adequately demonstrated efficacy in these

age groups.

: A warning to prescribers recommending close monitoring of

patients

at high risk of suicidal behaviour. These include patients with a

known history of suicidal behaviour or suicidal thoughts prior to

starting treatment and possibly also young adults.

: Prescribers and patients should be warned regarding the

occurrence

of withdrawal reactions upon stopping treatment. Generally these are

mild to moderate and self-limiting. However, in some patients they

may be severe and/or prolonged.

from ANNEX I – CHMP recommendations on Paroxetine

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

forumid=281849 & messageid=1102685964

[Guest guest]

: A warning to reflect that paroxetine should not be used in

children and adolescents. In the EU paroxetine is not authorised for

use in this population. Data from clinical trials raised concerns

regarding suicidal behaviour and hostility. In addition, data from

clinical trials have not adequately demonstrated efficacy in these

age groups.

: A warning to prescribers recommending close monitoring of

patients

at high risk of suicidal behaviour. These include patients with a

known history of suicidal behaviour or suicidal thoughts prior to

starting treatment and possibly also young adults.

: Prescribers and patients should be warned regarding the

occurrence

of withdrawal reactions upon stopping treatment. Generally these are

mild to moderate and self-limiting. However, in some patients they

may be severe and/or prolonged.

from ANNEX I – CHMP recommendations on Paroxetine

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

forumid=281849 & messageid=1102685964

[Guest guest]

: A warning to reflect that paroxetine should not be used in

children and adolescents. In the EU paroxetine is not authorised for

use in this population. Data from clinical trials raised concerns

regarding suicidal behaviour and hostility. In addition, data from

clinical trials have not adequately demonstrated efficacy in these

age groups.

: A warning to prescribers recommending close monitoring of

patients

at high risk of suicidal behaviour. These include patients with a

known history of suicidal behaviour or suicidal thoughts prior to

starting treatment and possibly also young adults.

: Prescribers and patients should be warned regarding the

occurrence

of withdrawal reactions upon stopping treatment. Generally these are

mild to moderate and self-limiting. However, in some patients they

may be severe and/or prolonged.

from ANNEX I – CHMP recommendations on Paroxetine

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

forumid=281849 & messageid=1102685964

[Guest guest]

: A warning to reflect that paroxetine should not be used in

children and adolescents. In the EU paroxetine is not authorised for

use in this population. Data from clinical trials raised concerns

regarding suicidal behaviour and hostility. In addition, data from

clinical trials have not adequately demonstrated efficacy in these

age groups.

: A warning to prescribers recommending close monitoring of

patients

at high risk of suicidal behaviour. These include patients with a

known history of suicidal behaviour or suicidal thoughts prior to

starting treatment and possibly also young adults.

: Prescribers and patients should be warned regarding the

occurrence

of withdrawal reactions upon stopping treatment. Generally these are

mild to moderate and self-limiting. However, in some patients they

may be severe and/or prolonged.

from ANNEX I – CHMP recommendations on Paroxetine

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

forumid=281849 & messageid=1102685964