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Canada web site safety alerts, public health advisories, press
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This is duplicated text of a letter from Eli Lilly Canada Inc.
Contact the company for
a copy of any references, attachments or
enclosures. |
Health Canada Endorsed
Important Safety Information on
PROZAC (fluoxetine
hydrochloride) |
May 18, 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 Healthcare Professional,
Eli Lilly 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 new Class warning incorporated in the product monograph of PROZAC
(fluoxetine hydrochloride) 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 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 SSRIs or other newer
anti-depressants should NOT be discontinued abruptly, due to risk of
discontinuation symptoms. PROZAC has only rarely been associated
with such 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, except for
fluoxetine, is recommended. Plasma fluoxetine and norfluoxetine
concentrations decrease gradually at the conclusion of therapy which
makes dose tapering unnecessary in most patients taking this drug
(see Product Monograph sections PRECAUTIONS: DISCONTINUATION OF
TREATMENT WITH PROZAC (POST-MARKETING AND CLINICAL TRIALS); ADVERSE
REACTIONS: Discontinuation of Treatment with Prozac (Post-Marketing
and Clinical Trials); DOSAGE AND ADMINISTRATION: DISCONTINUATION OF
TREATMENT WITH PROZAC). |
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.
Fluoxetine 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.
Eli Lilly 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 PROZAC (fluoxetine 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. Health care
professionals are asked to report any suspected adverse reactions in
patients receiving PROZAC (fluoxetine hydrochloride) directly to Eli Lilly
Canada Inc. or Health Canada at the following addresses:
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Customer Response Centre
Eli Lilly Canada Inc.
3650
Danforth Avenue
Toronto, Ontario
M1N 2E8
Toll Free Number:
1-888-545-5972
Fax: 1-888-898-2961
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.
Inquiries from healthcare professionals should be directed to Eli Lilly
Canada Customer Response Centre at 1-888-545-5972 between 8 a.m. and 6
p.m. EST.
Sincerely,
original signed by
Loren D. Grossman, MD, FRCPC, FACP
Vice President, Research and
Development
Eli Lilly Canada Inc.
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