Health Canada To Review Botox Safety
1 CommentBy Ed Silverman // January 30th, 2008 // 12:14 pm
Health Canada is reviewing safety information on Botox, just one week after Public Citizen petitioned the FDA to issue stronger safety warnings, The Canadian Press reports.
“Health Canada’s review of safety information on the issue of toxin spread regarding Botox began after departmental experts’ review of European studies,” Health Canada spokeswoman Carole Saindon wrote in an e-mail to the paper. If the review identifies any new safety information, “it will be made public to Canadians and Canadian health care professionals as soon as it is available…Canadians can be confident that after a thorough review, Health Canada will take action, if necessary.”
In its petition, Public Citizen wrote the FDA that the “European Union has posted a series of warnings concerning botulinum toxin (Botox) on its web site, the latest in March 2007, alerting physicians in its 27 member states about the need to monitor for signs of botulinum toxin adverse events. The UK and Germany amplified the EU warning with ‘Dear Doctor Letters,’ but no similar official warnings have been forthcoming from the FDA.”
The FDA has yet to react. Allergan, meanwhile, released a statement today in response to the move by Health Canada, maintaining that “reports of serious adverse events following Botox injection have been rare and there has never been a single reported death where a causal link to Botox Cosmeticwas established.”
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