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June 8, 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, Biovail Pharmaceuticals Canada (BPC), 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, including bupropion HCl, may be associated with behavioural and emotional changes, including risk of self harm. Bupropion is marketed in Canada as both the anti-depressant WELLBUTRIN® SR and the smoking cessation drug ZYBAN®. As findings from post-market spontaneous reports regarding agitation type events apply to ZYBAN® as well as WELLBUTRIN® SR, the following Class warning is therefore being incorporated into the labelling of both products. This warning applies to both adults and pediatrics. Please note that neither WELLBUTRIN® SR nor ZYBAN® have been fully evaluated in pediatrics, and these products are not indicated for use in patients less than 18 years of age.
It should be noted that a causal role for 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 or other newer anti-depressants should be rigorously monitored for clinical worsening, or onset/worsening of agitation-type adverse events or other indicators with a potential for suicidal behaviour. New Information Added to the Consumer Information Section The Consumer Information section of the product monographs has also 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, SNRIs (serotonin and norepinephrine reuptake inhibitors) and other newer antidepressants. The Panel agreed that a contraindication was not warranted for these drugs and supported Health Canada’s recommendations for stronger warnings, while providing suggestions and comments. The Record of Proceedings, and other information about the Panel, can be found on the Health Canada website at: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/sap_ssri_2004-02-20_rop_e.html. Subsequently Health Canada, in discussion with the Advisory Panel, decided to include bupropion, a NDRI (noradrenalin and dopamine reuptake inhibitor), in the warning due to case reports of labile emotions, predominantly exemplified by agitation. Biovail Pharmaceuticals 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 WELLBUTRIN® SR and ZYBAN® 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 WELLBUTRIN® SR or ZYBAN® directly to Biovail Pharmaceuticals Canada 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 Biovail Pharmaceuticals Canada Medical Information services at 1-866-825-8120. Sincerely, original signed by Kenneth Michalko, Pharm.D., MBA
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