Labelling on Botox changed to add detail on proper use, possible adverse reactions

Published Saturday October 11th, 2008
E9

TORONTO - Health Canada has received 13 reports describing adverse reactions in people who received Botox, according to the agency's latest adverse reaction newsletter.

The report includes data up to and including March 28 of this year, and all but one patient had the injections for therapeutic rather than cosmetic reasons.

The report's release coincides with word that Health Canada has approved new labelling for the product.

"These adverse events are all categorized as suggestive of distant toxin spread, suspected of being associated with botulinum toxin type A," said Caroline Van Hove, vice-president of corporate communications for Allergan Canada, which makes Botox and Botox Cosmetic.

Botox is used for medical reasons, and Botox Cosmetic is used for facial wrinkling. Botulinum toxin blocks nerve impulses to muscles, causing them to relax. In rare cases, the toxin may spread beyond the injection site to other parts of the body and result in problems such as paralysis of respiratory muscles and difficulty swallowing. Among the adverse event reports were five deaths, including two children with cerebral palsy.

But Van Hove noted that Health Canada's adverse events report doesn't establish cause and effect.

"What's important here is that the newsletter itself acknowledges that none of these are actually medically confirmed to be distant toxin spread," she said. "And even with the limited information available in the newsletter table of all the cases, you can clearly see that the confounding risk factors and the possible alternative causes are very apparent in these cases."

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