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This is
duplicated text of a letter from Wyeth
Pharmaceuticals.
Contact the company for a copy of any
references, attachments or enclosures. |
| Health Canada Endorsed
Important Safety Information on EFFEXOR and EFFEXOR XR
(venlafaxine)
|
May 26, 2004
Subject: Stronger WARNING for SSRIs and other newer
anti-depressants regarding the potential for behavioural and emotional
changes, including risk of self-harm
Dear Health Care Professional,
Wyeth Canada, 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
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 Effexor
and Effexor XR (venlafaxine) is provided below.
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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 the drugs in the class.
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 EFFEXOR or EFFEXOR
XR (venlafaxine) 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.
Venlafaxine 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 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
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
Wyeth Canada continues to work closely with Health Canada to monitor
adverse event reporting and to ensure that up-to-date information
regarding the use of Effexor and Effexor XR (venlafaxine) 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 Effexor or Effexor XR (venlafaxine) directly to Wyeth
Canada or Health Canada at the following addresses:
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Wyeth Medical Information & Pharmacovigilance
50 Minthorn
Boulevard
MARKHAM, Ontario, L3T 7Y2
Tel:
1-800-461-8844
Fax: (905) 470-4385
Any suspected adverse incident 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.
Please contact Wyeth Medical Information at 1-800-461-8844 with any
questions or concerns.
Sincerely,
original signed by
Neil Maresky, M.B., B.Ch.
Vice-President
Scientific Affairs
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