Health Canada has announced a new labelling protocol for Botox and Botox Cosmetic that will require warnings that there is a small risk of the toxin spreading to other parts of the body.
Botox is prescribed 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. Both are manufactured by Allergan Inc.
The announcement from Health Canada came in January following a recent safety review.
An Allergan Canada announcement posted on its website noted, “Muscle weakness remote to the site of injection and other serious adverse effects have been reported rarely for Botox in both pediatric and adult patients, and very rarely for Botox Cosmetic in adult patients …There were no fatalities involved in these very rare adverse events reported following esthetic use of Botox Cosmetic.”
Possible symptoms of "distant toxin spread," which can be fatal, include muscle weakness, swallowing difficulties, pneumonia, speech disorders and breathing problems, reports Health Canada.
Canadians using the products are advised to seek immediate medical care if swallowing, speech or breathing disorders arise. Canadians with a history of neurological disorders, swallowing difficulties or breathing problems should use these products with “extreme caution,” said Health Canada.
To report an adverse reaction, consumers and health professionals may call toll-free 866-234-2345 or email canadavigilance@hc-sc.gc.ca.
For more information visit allergan.ca.
