Dr. Patrick Treacy
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.
Dr. Patrick Treacy Chairman of the Irish Association of Cosmetic Doctors stated "We have been monitoring the situation in Canada for some time. 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"..
He continued "Health care professionals and consumers are reminded that botulinum toxin health products should be administered only at the recommended doses by authoriised personnel and for authoriised indications"
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