Archived – New Safety Information Regarding Botox and Botox Cosmetic Products
- Starting date:
- January 13, 2009
- Posting date:
- January 13, 2009
- Type of communication:
- Information Update
- Source of recall:
- Health Canada
- Product Safety, Microbial Hazard
- General Public
- Identification number:
Health Canada is informing Canadians and Canadian health care professionals that the labelling information of BOTOX® and BOTOX Cosmetic® will now include the risk of the toxin spreading to other distant parts of the body. Possible symptoms of "distant toxin spread," which can be fatal, include muscle weakness, swallowing difficulties, pneumonia, speech disorders and breathing problems.
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 be used only 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 website.
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 website
- 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
Ottawa, ON K1A 0K9
To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the Health Canada website. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.