Legal Updates

Health Canada Evaluating Botox Botulism Side Effects

Thursday, February 21, 2008

Health Canada announced on February 21, 2008 they are reviewing the possibility of "distant toxin spread" linked to Botox and Botox Cosmetic anti-wrinkle products. The U.S. FDA, on February 8, 2008 announced a comparable review after Botox was linked to possible adverse reactions, including respiratory failure and death. Botox consists of botulinum toxin A, which is closely related to botulism. Botulism is a neurotoxin produced by the bacterium Clostridium botulinum. Botulinum toxin A is one of the neurotoxins produced by Clostridium botulinum.

"Botulinum toxin when used as indicated, is expected to act locally to briefly paralyze a muscle or group of muscles," Health Canada spokesman Paul Duchesne said. "Distant toxin spread occurs when botulinum toxin disperses beyond the targeted muscle to areas of the body distant from the injection site. So, let's say you were to inject this in your arm, well it could go as far as your leg. So that's the issue here."

Botox is authorized in Canada for non-cosmetic purposes to decrease muscular responsiveness. It also is used to treat spasticity or muscle stiffness. Botox Cosmetic is authorized for cosmetic purposes, to decrease facial wrinkling.

Reports of adverse effects possibly related to distant toxin spread from botulinum toxin products began to surface in Europe in 2007. Health Canada then began a review of safety information on the issue of toxin spread from Botox and Botox Cosmetic. Duchesne said Health Canada's current review would analyze the use of Botox 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, but Duchesne said Health Canada is reminding doctors and consumers that botulinum health products should only be administered at the recommended doses by qualified health-care professionals.

Posted in Dangerous DrugsBotox

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