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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
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product or the company. Any questions regarding product information
should be discussed with your health professional.
This is duplicated text of a letter from Lundbeck Canada Inc.
Contact the company for
a copy of any references, attachments or
enclosures. |
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Health Canada Endorsed Important Safety
Information on CELEXA® (citalopram
hydrobromide) |
Lundbeck Canada Inc.
413 St. Jacques Street West
Suite
FB-230
Montreal, QC H2Y 1N9
May 26, 2004
Subject: 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,
Lundbeck 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 anti-depressants may be associated with behavioural and emotional
changes, including risk of self-harm.
The Class warning incorporated in the product monograph of
Celexa® (citalopram hydrobromide) 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 suggests 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 Celexa®
(citalopram hydrobromide) 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, patients should be closely supervised
throughout therapy with appropriate consideration to the possible need for
hospitalization. The 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.
Citalopram 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 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 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.
Lundbeck 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 Celexa® (citalopram hydrobromide) 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 Celexa® (citalopram hydrobromide) directly
to Lundbeck Canada Inc. or Health Canada at the following addresses:
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Lundbeck Canada Inc.
413 St. Jacques Street West
Suite
FB-230
Montreal, QC H2Y 1N9
Medical Information line at
Lundbeck Canada Inc. at
Tel No. 1-866-880-4636 (toll free) or
(514) 844-8088 (local).
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.
Any questions from health care professionals may be directed to the
Medical Information line at Lundbeck Canada Inc. at Tel No. 1-866-880-4636
(toll free) or (514) 844-8088 (local).
Sincerely,
original signed by
Marie Gagné, Ph.D.
Director, Medical and Clinical
Department
Lundbeck Canada Inc.
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