The makers of licensed botulinum toxin products like Botox and Myobloc will need to change their products' labeling to include boxed warnings on serious health problems that can result if the toxin spreads beyond the injection site, under a mandate issued today by the U.S. Food and Drug Administration (FDA).
The FDA order came after reports of adverse health problems and at least one death linked to the use of Botox to treat cerebral palsy and spasticity, which are uses that haven't been approved by the FDA.
Botox is typically injected into the skin or into muscle tissue, and has been approved by the FDA for cosmetic and other uses, including removal of frown lines, treatment of crossed eyes and eyelid twitches, and the prevention of severe underarm sweating. And no definitive health problems have been linked to the toxin spreading via these approved uses, Reuters reports.

