Public recall detail

Archived – Important Drug Safety Information for WELLBUTRIN® SR and ZYBAN® (Bupropion HCI): Warning for SSRIs and Other Newer Anti-Depressants Regarding the Potential for Behavioural and Emotional Changes, Including Risk of Self-Harm

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Quick summary: Archived – Important Drug Safety Information for WELLBUTRIN® SR and ZYBAN® (Bupropion HCI): Warning for SSRIs and Other Newer Anti-Depressants Regarding the Potential for Behavioural and Emotional Changes, Including Risk of Self-Harm .

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Recall details

Quick summary: Archived – Important Drug Safety Information for WELLBUTRIN® SR and ZYBAN® (Bupropion HCI): Warning for SSRIs and Other Newer Anti-Depressants Regarding the Potential for Behavioural and Emotional Changes, Including Risk of Self-Harm .

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Background{"text":"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/dhp-mps/prodpharma/activit/sci-consult/serotonin/sapssri_rop_gcsisrs_crd_2004-02-20-eng.php. 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: Biovail Pharmaceuticals Canada 7150 Mississauga Rd. Mississauga, Ontario. L5N 8M5 Tel: 866-825-8120 Fax: 905-286-3256 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. 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 Vice President, Regulatory Affairs Biovail Pharmaceuticals Canada"}
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Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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