Health Canada / SantÚ Canada - Government of Canada
Franšais Contact Us Help Search Canada Site

Therapeutic Products Directorate: TPD-Web
  Copyright Requests | Needed Downloads
Skip all menus (access key: Z) Skip first menu (access key: X)
cornerspacercorner
line bar
line bar
 Advisories and
 Warnings
 Regulatory  Requirements for  Advertising
 Special Access
 Programme
 Activities
 Communications

cornerspacercorner

Spacer
Contact
bcans Enquiries
This document is also available in PDF format
[paxil_hpc_e.pdf]
Pages: 4, Size: 62 K, Date: 2004-06-02


The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from GlaxoSmithKline Inc..
Contact the company for a copy of any references, attachments or enclosures.



Health Canada Endorsed Important Safety Information on
PAXIL« (paroxetine)

GlaxoSmithKline

May 2004

Subject: Stronger WARNING for SSRIs and other newer anti-depressants regarding the potential for behavioural and emotional changes, including risk of self-harm. For paroxetine, this replaces the previous interim contraindication

Dear Health Care Professional,

GlaxoSmithKline Inc. (GSK), following discussions with Health Canada, would like to inform you of important safety information regarding the possibility that selective serotonin reuptake inhibitors (SSRIs) and other newer anti-depressants may be associated with behavioural and emotional changes, including risk of self-harm.

The new Class warning incorporated in the product monograph of paroxetine is provided below.

Please note this warning replaces the interim contraindication for Paxil« (paroxetine) issued in July 2003 for patients under 18 years of age with Major Depressive Disorder.

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 anti-depressants 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 anti-depressants, 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 behaviour is advised in patients of all ages. This includes monitoring for agitation-type emotional and behavioural changes.

Discontinuation Symptoms

Patients currently taking paroxetine 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 anti-depressant 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 anti-depressants 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 anti-depressants should be rigorously monitored for clinical worsening, or onset/worsening of agitation-type adverse events, or other indicators of potential for suicidal behaviour.

Paroxetine is not indicated for use in the pediatric population, and controlled clinical studies with paroxetine in children and adolescents under 18 years of age with major depressive disorder failed to demonstrate efficacy.

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 anti-depressants 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 post-marketing reports for SSRIs and other newer anti-depressants. 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.

GSK continues to work closely with Health Canada to monitor adverse event reporting and to ensure that up-to-date information regarding the use of paroxetine is available.

The identification, characterization and management of drug-related adverse events are dependent on the active participation of health-care professionals in adverse drug reaction reporting programs. Healthcare professionals are asked to report any suspected adverse reactions in patients receiving PAXIL« and PAXIL CRTM (paroxetine hydrochloride) directly to GSK or Health Canada at the following addresses.

GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga, Ontario
L5N 6L4
Tel: 1-800-387-7374

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, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

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.

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 health care professionals may be directed to Medical Information via GSK Customer service at 1-800-387-7374.

Sincerely,

original signed by

Anne Phillips, M.D., FRCPC
Vice-President, Research & Development and Chief Medical Officer
GlaxoSmithKline Inc

 

Previous  
Blue Bar
Last Updated - 2004-06-03 Top of page Important Notices