2008-29
February 14, 2008
OTTAWA - Health Canada is informing Canadians of an ongoing safety review of distant toxin spread potentially associated with Botox and Botox Cosmetic. A similar review was recently announced by the US Food and Drug Administration linking Botox and Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B) to cases of adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a range of doses.
Botox is authorized in Canada for non-cosmetic purposes to decrease muscular responsiveness, and is used to treat spasticity or muscle stiffness. Botox Cosmetic is authorized for cosmetic purposes, to decrease facial wrinkling. Myobloc is not currently marketed in Canada.
Botulinum toxin, when used as indicated, is expected to act locally, to temporarily paralyze a muscle or group of muscles. Distant toxin spread occurs when botulinum toxin disperses beyond the targeted muscle(s) to areas of the body distant from the injection site.
Reports of adverse events possibly related to distant toxin spread from botulinum toxin products were first made public in Europe in 2007. Health Canada then began a review of safety information on the issue of toxin spread from Botox and Botox Cosmetic. This ongoing review will involve the analysis of Botox as it relates to use in both adults and children, including whether additional precautionary measures are required.
No confirmed cases of distant toxin spread related to Botox or Botox Cosmetic have been reported in Canada.
Health Canada reminds physicians and consumers that botulinum health products should only be administered at the recommended doses, for authorized indications, by qualified healthcare professionals.
Patients should contact their physician or pharmacist if they have questions about Botox or Botox Cosmetic.
Consumers requiring more information about this Information Update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction to these products, please contact the Canada Vigilance Program of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9
E-mail: CanadaVigilance@hc-sc.gc.ca
The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect area of the Health Canada Web site.
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Media Inquiries:
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
1-866 225-0709
