FDA Changes Box Warnings for Botox

Source:  US FDA Press Announcements

Botulinum Toxin (Botox), a poison used to treat “crow’s feet”, “wrinkles”, “frown lines” and to prevent underarm sweating,  has undergone some labeling revisions and guidelines.

The warnings include the risk that the botox may spread from the areas injected to other areas of the body causing symptoms consistent with botulism. These include: swallowing and breathing difficulties which could result in airway compromise and death.  What price vanity?

Oddly, the warnings were prompted by an off-label (unapproved) use for the drug, to treat muscle spasticity in children with cerebral palsy and not at the recommended dosages for the cosmetic use of botox.  FDA Approved botox products include: Botox; Botox Cosmetic; Myobloc;, and Dysport.

It may work but it is derived from poison so it’s not a terrible idea to pay attention.  Standard caveat applies: Consult your physician or aesthetician.

posted by David Marc Schwadron, Esquire