This update comes in light of Health Canada's recent safety review of distant toxin spread from Botox and Botox Cosmetic products. Health Canada has worked with the manufacturer, Allergan, to revise the labelling of these products on the Canadian market. It is important to note that there are no medically confirmed cases of distant toxin spread related to Botox or Botox Cosmetic in Canada.
Health Canada would also like to advise Canadians using Botox and Botox Cosmetic products to seek immediate medical care if swallowing, speech or breathing disorders arise. Canadians with a history of underlying neurological disorders, swallowing difficulties and/or breathing problems should use these products with extreme caution. Botox and Botox Cosmetic products should only be used under specialist supervision in those patients and should only be used if the benefit of treatment is considered to outweigh the risk.
Botox and Botox Cosmetic, manufactured by Allergan Inc., is the only botulinum toxin products marketed in Canada. Botox is indicated for the treatment of muscle spasms in the neck, eye and foot, muscle pain, and excessive sweating. Botox Cosmetic is indicated for cosmetic purposes, to treat facial wrinkling.
Patients using Botox and Botox Cosmetic products should consult with their physician if they have any questions or concerns.
Health Canada will continue to monitor the safety of Botox and Botox Cosmetic products and Canadians will continue to be informed if new safety information arises.
More information on Botox and Botox Cosmetic products, including prescribing and patient information, can be found in Health Canada's Drug Product Database. Health Canada's previous advisory on Botox is also available on the Health Canada Web site.
Consumers requiring more information about this advisory can contact Health Canada's public inquiries line at (613) 957-2991, or call toll free at 1-866-225-0709.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways :
- Report online at the MedEffect ™ Canada section of the Health Canada Web site
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and either:
- Fax toll-free to 1-866-678-6789
- Mail to: Canada Vigilance Program
Health Canada
AL 0701C
Ottawa, ON K1A 0K9
To have postage pre-paid, download the postage paid label from the MedEffect ™ Canada section of the Health Canada Web site. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.
Media Inquiries:
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
1-866 225-0709
No comments:
Post a Comment