ZOLOFT (Lustral) - Health Canada Endorse Important Safety Information

[Guest guest]

Health Canada Endorsed Important Safety Information on

ZOLOFT (sertraline hydrochloride)

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/zoloft_hpc_e.pdf

May 26, 2004

Subject: Stronger WARNING for SSRIs and other newer antidepressants

regarding

the potential for behavioural and emotional changes, including risk

of

selfharm

Dear Healthcare Professional,

Pfizer Canada Inc., following discussions with Health Canada, would

like to

inform you of

important safety information regarding the possibility that SSRIs

(selective

serotonin reuptake

inhibitors) and other newer antidepressants may be associated with

behavioural and emotional

changes, including risk of self-harm.

The new Class warning incorporated in the Product Monograph of

ZOLOFT*

(sertraline

hydrochloride) capsules is provided below.

POTENTIAL ASSOCIATION WITH THE OCCURRENCE OF BEHAVIOURAL AND

EMOTIONAL CHANGES, INCLUDING SELF-HARM.

Pediatrics: Placebo-Controlled Clinical Trial Data

.. Recent analyses of placebo-controlled clinical trial safety

databases from

SSRIs and other newer antidepressants suggest that use of these

drugs in

patients under the age of 18 may be associated with behavioural and

emotional

changes, including an increased risk of suicidal ideation and

behaviour over

that of placebo.

.. The small denominators in the clinical trial database, as well as

the

variability in

placebo rates, preclude reliable conclusions on the relative safety

profiles

among these drugs.

Adult and Pediatrics: Additional data

.. There are clinical trial and post-marketing reports with SSRIs and

other

newer

antidepressants, in both pediatrics and adults, of severe agitation-

type

adverse

events coupled with self-harm or harm to others. The agitation-type

events

include: akathisia, agitation, disinhibition, emotional lability,

hostility,

aggression, depersonalization. In some cases, the events occurred

within

several weeks of starting treatment.

Rigorous clinical monitoring for suicidal ideation or other

indicators of

potential for

suicidal behavior is advised in patients of all ages. This includes

monitoring for

agitation-type emotional and behavioural changes.

Discontinuation Symptoms [aka: WITHDRAWAL FROM ADDICTION]

Patients currently taking sertraline hydrochloride should NOT be

discontinued

abruptly, due to risk of discontinuation symptoms. At the time that a

medical decision

is made to discontinue an SSRI or other newer antidepressant drug, a

gradual

reduction in the dose rather than an abrupt cessation is recommended.

It should be noted that a causal role for SSRIs and other newer

antidepressants in inducing

self-harm or harm to others has not been established. The

possibility of a

suicide attempt is

inherent in depression and other psychiatric disorders, and may

persist

until remission occurs.

Therefore, high-risk patients should be closely supervised throughout

therapy with appropriate

consideration to the possible need for hospitalization. The updated

warning

informs

practitioners that all patients being treated with SSRIs and other

newer

antidepressants should

be rigorously monitored for clinical worsening, or onset/ worsening

of

agitation-type adverse

events, or other indicators of potential for suicidal behaviour.

Sertraline hydrochloride is not indicated for use in the pediatric

population

New Information Added to the Consumer Information Section

The Consumer Information Section of the Product Monograph has been

updated

to reflect this new

Class warning, and to advise patients that treatment with SSRIs and

other

newer antidepressants

is most safe and effective when there is good communication with the

treating physician about how

the patient is feeling.

Background

In February 2004, a scientific advisory panel set up by Health

Canada was

asked to provide the

clinical practice perspective on the pediatric clinical trial safety

data,

and the spontaneous postmarketing

reports for SSRIs and other newer antidepressants. The panel agreed

that a

contraindication was not warranted for these medications, and

supported

Health Canada's

recommendation for stronger warnings, while providing suggestions and

comments. The record

of proceedings, and other information about the panel, can be found

on

Health Canada's website

at http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/sap_ssri_2004-02-

20_rop_e.html.

Pfizer Canada Inc. continues to work closely with Health Canada to

monitor

adverse event

reporting and to ensure that up-to-date information regarding the

use of

ZOLOFT (sertraline

hydrochloride) is available.

The identification, characterization and management of drug-related

adverse

events are dependent

on the active participation of healthcare professionals in adverse

drug

reaction reporting programs.

Healthcare professionals are asked to report any suspected adverse

reactions

in patients receiving

ZOLOFT (sertraline hydrochloride) directly to Pfizer Canada Inc. or

Health

Canada at the following

addresses:

Pfizer Canada Inc.

Medical Information

P.O. Box 800

Pointe-, Quebec

H9R 4V2

1 800 463-6001

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: (613) 957-0337 or Fax: (613) 957-0335

To report an Adverse Reaction, consum ers and health professionals

may call

toll free:

Tel: 866 234-2345

Fax: 866 678-6789

cadrmp@h...

For other inquiries: please refer to contact information.

The AR Reporting Form and the AR Guidelines can be found on the

Health

Canada web site or in The Canadian

Compendium of Pharmaceuticals and Specialties.

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.html

http://www .hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.htm l

Your professional commitment in this regard has an important role in

protecting the well-being of

your patients by contributing to early signal detection and informed

drug

use.

Any questions from healthcare professionals may be directed to the

Pfizer

Medical Information

Group at Tel: 1 800 463-6001.

Sincerely,

original signed by

Bernard Prigent, M.D.

Vice President & Medical Director

Pfizer Canada Inc.

*Trademark Pfizer Inc.

Pfizer Canada Inc. Licensee

[Guest guest]

Health Canada Endorsed Important Safety Information on

ZOLOFT (sertraline hydrochloride)

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/zoloft_hpc_e.pdf

May 26, 2004

Subject: Stronger WARNING for SSRIs and other newer antidepressants

regarding

the potential for behavioural and emotional changes, including risk

of

selfharm

Dear Healthcare Professional,

Pfizer Canada Inc., following discussions with Health Canada, would

like to

inform you of

important safety information regarding the possibility that SSRIs

(selective

serotonin reuptake

inhibitors) and other newer antidepressants may be associated with

behavioural and emotional

changes, including risk of self-harm.

The new Class warning incorporated in the Product Monograph of

ZOLOFT*

(sertraline

hydrochloride) capsules is provided below.

POTENTIAL ASSOCIATION WITH THE OCCURRENCE OF BEHAVIOURAL AND

EMOTIONAL CHANGES, INCLUDING SELF-HARM.

Pediatrics: Placebo-Controlled Clinical Trial Data

.. Recent analyses of placebo-controlled clinical trial safety

databases from

SSRIs and other newer antidepressants suggest that use of these

drugs in

patients under the age of 18 may be associated with behavioural and

emotional

changes, including an increased risk of suicidal ideation and

behaviour over

that of placebo.

.. The small denominators in the clinical trial database, as well as

the

variability in

placebo rates, preclude reliable conclusions on the relative safety

profiles

among these drugs.

Adult and Pediatrics: Additional data

.. There are clinical trial and post-marketing reports with SSRIs and

other

newer

antidepressants, in both pediatrics and adults, of severe agitation-

type

adverse

events coupled with self-harm or harm to others. The agitation-type

events

include: akathisia, agitation, disinhibition, emotional lability,

hostility,

aggression, depersonalization. In some cases, the events occurred

within

several weeks of starting treatment.

Rigorous clinical monitoring for suicidal ideation or other

indicators of

potential for

suicidal behavior is advised in patients of all ages. This includes

monitoring for

agitation-type emotional and behavioural changes.

Discontinuation Symptoms [aka: WITHDRAWAL FROM ADDICTION]

Patients currently taking sertraline hydrochloride should NOT be

discontinued

abruptly, due to risk of discontinuation symptoms. At the time that a

medical decision

is made to discontinue an SSRI or other newer antidepressant drug, a

gradual

reduction in the dose rather than an abrupt cessation is recommended.

It should be noted that a causal role for SSRIs and other newer

antidepressants in inducing

self-harm or harm to others has not been established. The

possibility of a

suicide attempt is

inherent in depression and other psychiatric disorders, and may

persist

until remission occurs.

Therefore, high-risk patients should be closely supervised throughout

therapy with appropriate

consideration to the possible need for hospitalization. The updated

warning

informs

practitioners that all patients being treated with SSRIs and other

newer

antidepressants should

be rigorously monitored for clinical worsening, or onset/ worsening

of

agitation-type adverse

events, or other indicators of potential for suicidal behaviour.

Sertraline hydrochloride is not indicated for use in the pediatric

population

New Information Added to the Consumer Information Section

The Consumer Information Section of the Product Monograph has been

updated

to reflect this new

Class warning, and to advise patients that treatment with SSRIs and

other

newer antidepressants

is most safe and effective when there is good communication with the

treating physician about how

the patient is feeling.

Background

In February 2004, a scientific advisory panel set up by Health

Canada was

asked to provide the

clinical practice perspective on the pediatric clinical trial safety

data,

and the spontaneous postmarketing

reports for SSRIs and other newer antidepressants. The panel agreed

that a

contraindication was not warranted for these medications, and

supported

Health Canada's

recommendation for stronger warnings, while providing suggestions and

comments. The record

of proceedings, and other information about the panel, can be found

on

Health Canada's website

at http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/sap_ssri_2004-02-

20_rop_e.html.

Pfizer Canada Inc. continues to work closely with Health Canada to

monitor

adverse event

reporting and to ensure that up-to-date information regarding the

use of

ZOLOFT (sertraline

hydrochloride) is available.

The identification, characterization and management of drug-related

adverse

events are dependent

on the active participation of healthcare professionals in adverse

drug

reaction reporting programs.

Healthcare professionals are asked to report any suspected adverse

reactions

in patients receiving

ZOLOFT (sertraline hydrochloride) directly to Pfizer Canada Inc. or

Health

Canada at the following

addresses:

Pfizer Canada Inc.

Medical Information

P.O. Box 800

Pointe-, Quebec

H9R 4V2

1 800 463-6001

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: (613) 957-0337 or Fax: (613) 957-0335

To report an Adverse Reaction, consum ers and health professionals

may call

toll free:

Tel: 866 234-2345

Fax: 866 678-6789

cadrmp@h...

For other inquiries: please refer to contact information.

The AR Reporting Form and the AR Guidelines can be found on the

Health

Canada web site or in The Canadian

Compendium of Pharmaceuticals and Specialties.

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.html

http://www .hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.htm l

Your professional commitment in this regard has an important role in

protecting the well-being of

your patients by contributing to early signal detection and informed

drug

use.

Any questions from healthcare professionals may be directed to the

Pfizer

Medical Information

Group at Tel: 1 800 463-6001.

Sincerely,

original signed by

Bernard Prigent, M.D.

Vice President & Medical Director

Pfizer Canada Inc.

*Trademark Pfizer Inc.

Pfizer Canada Inc. Licensee

[Guest guest]

Health Canada Endorsed Important Safety Information on

ZOLOFT (sertraline hydrochloride)

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/zoloft_hpc_e.pdf

May 26, 2004

Subject: Stronger WARNING for SSRIs and other newer antidepressants

regarding

the potential for behavioural and emotional changes, including risk

of

selfharm

Dear Healthcare Professional,

Pfizer Canada Inc., following discussions with Health Canada, would

like to

inform you of

important safety information regarding the possibility that SSRIs

(selective

serotonin reuptake

inhibitors) and other newer antidepressants may be associated with

behavioural and emotional

changes, including risk of self-harm.

The new Class warning incorporated in the Product Monograph of

ZOLOFT*

(sertraline

hydrochloride) capsules is provided below.

POTENTIAL ASSOCIATION WITH THE OCCURRENCE OF BEHAVIOURAL AND

EMOTIONAL CHANGES, INCLUDING SELF-HARM.

Pediatrics: Placebo-Controlled Clinical Trial Data

.. Recent analyses of placebo-controlled clinical trial safety

databases from

SSRIs and other newer antidepressants suggest that use of these

drugs in

patients under the age of 18 may be associated with behavioural and

emotional

changes, including an increased risk of suicidal ideation and

behaviour over

that of placebo.

.. The small denominators in the clinical trial database, as well as

the

variability in

placebo rates, preclude reliable conclusions on the relative safety

profiles

among these drugs.

Adult and Pediatrics: Additional data

.. There are clinical trial and post-marketing reports with SSRIs and

other

newer

antidepressants, in both pediatrics and adults, of severe agitation-

type

adverse

events coupled with self-harm or harm to others. The agitation-type

events

include: akathisia, agitation, disinhibition, emotional lability,

hostility,

aggression, depersonalization. In some cases, the events occurred

within

several weeks of starting treatment.

Rigorous clinical monitoring for suicidal ideation or other

indicators of

potential for

suicidal behavior is advised in patients of all ages. This includes

monitoring for

agitation-type emotional and behavioural changes.

Discontinuation Symptoms [aka: WITHDRAWAL FROM ADDICTION]

Patients currently taking sertraline hydrochloride should NOT be

discontinued

abruptly, due to risk of discontinuation symptoms. At the time that a

medical decision

is made to discontinue an SSRI or other newer antidepressant drug, a

gradual

reduction in the dose rather than an abrupt cessation is recommended.

It should be noted that a causal role for SSRIs and other newer

antidepressants in inducing

self-harm or harm to others has not been established. The

possibility of a

suicide attempt is

inherent in depression and other psychiatric disorders, and may

persist

until remission occurs.

Therefore, high-risk patients should be closely supervised throughout

therapy with appropriate

consideration to the possible need for hospitalization. The updated

warning

informs

practitioners that all patients being treated with SSRIs and other

newer

antidepressants should

be rigorously monitored for clinical worsening, or onset/ worsening

of

agitation-type adverse

events, or other indicators of potential for suicidal behaviour.

Sertraline hydrochloride is not indicated for use in the pediatric

population

New Information Added to the Consumer Information Section

The Consumer Information Section of the Product Monograph has been

updated

to reflect this new

Class warning, and to advise patients that treatment with SSRIs and

other

newer antidepressants

is most safe and effective when there is good communication with the

treating physician about how

the patient is feeling.

Background

In February 2004, a scientific advisory panel set up by Health

Canada was

asked to provide the

clinical practice perspective on the pediatric clinical trial safety

data,

and the spontaneous postmarketing

reports for SSRIs and other newer antidepressants. The panel agreed

that a

contraindication was not warranted for these medications, and

supported

Health Canada's

recommendation for stronger warnings, while providing suggestions and

comments. The record

of proceedings, and other information about the panel, can be found

on

Health Canada's website

at http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/sap_ssri_2004-02-

20_rop_e.html.

Pfizer Canada Inc. continues to work closely with Health Canada to

monitor

adverse event

reporting and to ensure that up-to-date information regarding the

use of

ZOLOFT (sertraline

hydrochloride) is available.

The identification, characterization and management of drug-related

adverse

events are dependent

on the active participation of healthcare professionals in adverse

drug

reaction reporting programs.

Healthcare professionals are asked to report any suspected adverse

reactions

in patients receiving

ZOLOFT (sertraline hydrochloride) directly to Pfizer Canada Inc. or

Health

Canada at the following

addresses:

Pfizer Canada Inc.

Medical Information

P.O. Box 800

Pointe-, Quebec

H9R 4V2

1 800 463-6001

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: (613) 957-0337 or Fax: (613) 957-0335

To report an Adverse Reaction, consum ers and health professionals

may call

toll free:

Tel: 866 234-2345

Fax: 866 678-6789

cadrmp@h...

For other inquiries: please refer to contact information.

The AR Reporting Form and the AR Guidelines can be found on the

Health

Canada web site or in The Canadian

Compendium of Pharmaceuticals and Specialties.

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.html

http://www .hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.htm l

Your professional commitment in this regard has an important role in

protecting the well-being of

your patients by contributing to early signal detection and informed

drug

use.

Any questions from healthcare professionals may be directed to the

Pfizer

Medical Information

Group at Tel: 1 800 463-6001.

Sincerely,

original signed by

Bernard Prigent, M.D.

Vice President & Medical Director

Pfizer Canada Inc.

*Trademark Pfizer Inc.

Pfizer Canada Inc. Licensee

[Guest guest]

Health Canada Endorsed Important Safety Information on

ZOLOFT (sertraline hydrochloride)

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/zoloft_hpc_e.pdf

May 26, 2004

Subject: Stronger WARNING for SSRIs and other newer antidepressants

regarding

the potential for behavioural and emotional changes, including risk

of

selfharm

Dear Healthcare Professional,

Pfizer Canada Inc., following discussions with Health Canada, would

like to

inform you of

important safety information regarding the possibility that SSRIs

(selective

serotonin reuptake

inhibitors) and other newer antidepressants may be associated with

behavioural and emotional

changes, including risk of self-harm.

The new Class warning incorporated in the Product Monograph of

ZOLOFT*

(sertraline

hydrochloride) capsules is provided below.

POTENTIAL ASSOCIATION WITH THE OCCURRENCE OF BEHAVIOURAL AND

EMOTIONAL CHANGES, INCLUDING SELF-HARM.

Pediatrics: Placebo-Controlled Clinical Trial Data

.. Recent analyses of placebo-controlled clinical trial safety

databases from

SSRIs and other newer antidepressants suggest that use of these

drugs in

patients under the age of 18 may be associated with behavioural and

emotional

changes, including an increased risk of suicidal ideation and

behaviour over

that of placebo.

.. The small denominators in the clinical trial database, as well as

the

variability in

placebo rates, preclude reliable conclusions on the relative safety

profiles

among these drugs.

Adult and Pediatrics: Additional data

.. There are clinical trial and post-marketing reports with SSRIs and

other

newer

antidepressants, in both pediatrics and adults, of severe agitation-

type

adverse

events coupled with self-harm or harm to others. The agitation-type

events

include: akathisia, agitation, disinhibition, emotional lability,

hostility,

aggression, depersonalization. In some cases, the events occurred

within

several weeks of starting treatment.

Rigorous clinical monitoring for suicidal ideation or other

indicators of

potential for

suicidal behavior is advised in patients of all ages. This includes

monitoring for

agitation-type emotional and behavioural changes.

Discontinuation Symptoms [aka: WITHDRAWAL FROM ADDICTION]

Patients currently taking sertraline hydrochloride should NOT be

discontinued

abruptly, due to risk of discontinuation symptoms. At the time that a

medical decision

is made to discontinue an SSRI or other newer antidepressant drug, a

gradual

reduction in the dose rather than an abrupt cessation is recommended.

It should be noted that a causal role for SSRIs and other newer

antidepressants in inducing

self-harm or harm to others has not been established. The

possibility of a

suicide attempt is

inherent in depression and other psychiatric disorders, and may

persist

until remission occurs.

Therefore, high-risk patients should be closely supervised throughout

therapy with appropriate

consideration to the possible need for hospitalization. The updated

warning

informs

practitioners that all patients being treated with SSRIs and other

newer

antidepressants should

be rigorously monitored for clinical worsening, or onset/ worsening

of

agitation-type adverse

events, or other indicators of potential for suicidal behaviour.

Sertraline hydrochloride is not indicated for use in the pediatric

population

New Information Added to the Consumer Information Section

The Consumer Information Section of the Product Monograph has been

updated

to reflect this new

Class warning, and to advise patients that treatment with SSRIs and

other

newer antidepressants

is most safe and effective when there is good communication with the

treating physician about how

the patient is feeling.

Background

In February 2004, a scientific advisory panel set up by Health

Canada was

asked to provide the

clinical practice perspective on the pediatric clinical trial safety

data,

and the spontaneous postmarketing

reports for SSRIs and other newer antidepressants. The panel agreed

that a

contraindication was not warranted for these medications, and

supported

Health Canada's

recommendation for stronger warnings, while providing suggestions and

comments. The record

of proceedings, and other information about the panel, can be found

on

Health Canada's website

at http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/sap_ssri_2004-02-

20_rop_e.html.

Pfizer Canada Inc. continues to work closely with Health Canada to

monitor

adverse event

reporting and to ensure that up-to-date information regarding the

use of

ZOLOFT (sertraline

hydrochloride) is available.

The identification, characterization and management of drug-related

adverse

events are dependent

on the active participation of healthcare professionals in adverse

drug

reaction reporting programs.

Healthcare professionals are asked to report any suspected adverse

reactions

in patients receiving

ZOLOFT (sertraline hydrochloride) directly to Pfizer Canada Inc. or

Health

Canada at the following

addresses:

Pfizer Canada Inc.

Medical Information

P.O. Box 800

Pointe-, Quebec

H9R 4V2

1 800 463-6001

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: (613) 957-0337 or Fax: (613) 957-0335

To report an Adverse Reaction, consum ers and health professionals

may call

toll free:

Tel: 866 234-2345

Fax: 866 678-6789

cadrmp@h...

For other inquiries: please refer to contact information.

The AR Reporting Form and the AR Guidelines can be found on the

Health

Canada web site or in The Canadian

Compendium of Pharmaceuticals and Specialties.

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.html

http://www .hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.htm l

Your professional commitment in this regard has an important role in

protecting the well-being of

your patients by contributing to early signal detection and informed

drug

use.

Any questions from healthcare professionals may be directed to the

Pfizer

Medical Information

Group at Tel: 1 800 463-6001.

Sincerely,

original signed by

Bernard Prigent, M.D.

Vice President & Medical Director

Pfizer Canada Inc.

*Trademark Pfizer Inc.

Pfizer Canada Inc. Licensee