"Black box" warnings and generic name changes for botulinum products in US
This article was originally published in Scrip
Executive Summary
The US FDA has added a "black box" warning to all botulinum-containing products, cautioning against "life-threatening" adverse events in cases where the toxin spreads beyond the injection site. The products' established drug names also have been changed to differentiate them and reduce the potential for dosing errors owing to inappropriate substitution.