Botox Black Box Warning: AAD Responds

The FDA recently announced that a boxed warning ("black box warning") will be added to the labeling of botulinum toxin products (Botox, Dysport) and a medication guide will be distributed to patients receiving these products for any use.

The American Academy of Dermatology (AAD) today issued a statement in response to the U.S. Food and Drug Administration's (FDA) announcement. See the Botulinum Toxin Black Box Review that provides answer to frequently asked questions regarding this new statement by the FDA.

"The health, safety and welfare of our patients being treated with botulinum toxin products are of paramount importance to dermatologists," said dermatologist David M. Pariser, MD, president of the American Academy of Dermatology. "While no serious side effects have been reported from the dermatologic use of botulinum toxin products, the FDA's actions emphasize the importance of selecting a qualified physician to administer these products for medical and cosmetic uses."