FDA Requires Boxed Warning for All Botulinum Toxin Products
Prompted by reports of serious adverse events, the U.S. Food and Drug
Administration announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation
Strategy (REMS), are necessary for all botulinum toxin products. The agency said it took the action because of reports
that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing
symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble
talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred
vision and drooping eyelids. These symptoms have mostly been reported in children with cerebral palsy being treated with
the products for muscle spasticity, an unapproved use of the drugs. Symptoms have also been reported in adults treated
both for approved and unapproved uses. Read more...
