Is the Canadian Government going overboard with regard to Botox?

Posted on the 10 February 2010 at 17:23

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. 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. Health Canada is also advising 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 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.

However closer evaluation of the facts give rise to some concern. As of March 2008, Health Canada received 13 reports describing adverse reactions suggestive of distant toxin spread suspected of being associated with Botox. In reality none was medically confirmed as distant toxin spread. All but 1 patient received Botox for a therapeutic rather than a cosmetic indication. It is important to note that there are no medically confirmed cases of distant toxin spread related to Botox or Botox Cosmetic in Canada and on this basis I would be very surprised if any other country followed their lead. However we should be aware that a similar situation could happen in the UK or Ireland. 
What are your thoughts on the matter?

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Blog Comment(s) [1]

These risks are on our consent forms but I am not sure they need to be as the risk are much less than 1%. I am not aware of any published data which confirms distance spread from cosmetic indications with Botox or Dysport. I personally have never seen any systemic effects following any injection.

Dr Ravi Jain |