TORONTO - Health Canada says the labels on Botox products are being changed to warn that use may result in spread of the toxin to other parts of the body, potentially with fatal consequences.
The department says symptoms of "distant toxin spread" include muscle weakness, swallowing difficulties, pneumonia, speech disorders and breathing problems.
The risks came to light in a recent Health Canada safety review of distant toxin spread from Botox and Botox Cosmetic products, made by Allergan Inc. of Irvine, Calif.
Botox is approved for use in the treatment of muscle spasms in the neck, eye and foot, muscle pain and excessive sweating while Botox Cosmetic is approved for esthetic purposes such as the slowing of facial wrinkling.
Health Canada says there have been no medically confirmed cases in Canada of distant toxin spread.
But it says Canadians who use Botox and Botox Cosmetic products should immediately seek medical care if they develop swallowing, speech or breathing problems after use.
Health Canada further warns that Canadians with a history of neurological disorders, swallowing difficulties and-or breathing problems should use the products with extreme caution.
Botox and Botox Cosmetic are the only botulinum toxin products marketed in Canada.
Last February the U.S. Food and Drug Administration warned the distant spread phenomenon had been reported in both in FDA-approved and non-approved uses of Botox.
It said the most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy -- an experimental treatment not currently approved by the FDA.
Health Canada says it will continue to monitor the safety of Botox and Botox Cosmetic products.
