May 26, 2004
Subject: Stronger WARNING for SSRIs and other newer antidepressants regarding the potential for behavioural and emotional changes, including risk of self- harm
Dear Health Care 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.
IIt 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.
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 :
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:
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.
original signed by
Bernard Prigent, M.D.
*Trademark Pfizer Inc.