What Is The Botox Black Box Warning?

In 2009, the FDA issued a “Black Box” warning for Botox that has now carried over to all neuromodulators such as Dysport and Xeomin.

A Black Box warning is the most serious warning that the FDA may issue for drugs/medications that have potentially dangerous side effects. Because of the potential spread to distant areas after injection, Botox (and its sister products) was given this warning on its packaging.

Let’s consider the following:

• When Botox/Dysport are received directly from the manufacturer and used responsibly by a trained practitioner, treatments are extremely safe.
• Botox has a higher safety rating than Aspirin.
• Botox (neuromodulators) is the #1 cosmetic treatment in the world.
• Reports of distant spread of Botox were associated with very large doses in patients already with compromised health wherein the risks of treatment were outweighed by potential benefits. (ex: cerebral palsy)
• Cases wherein patients suffered great harm were associated with “bootleg” Botox that was not received directly from the manufacturer.
• A more recent case of distant spread was related to the use of high doses in the neck for platysmal bands that resulted in compromised swallowing for more than a couple of months. We do NOT use Botox/Dysport in the neck as we believe this is far left off-label wherein benefits are outweighed by potential risks.
• Finally, there are many common drugs that carry a Black Box warning such as:

Cipro (a common antibiotic), anti-depressants, anti-coagulants, anti-diabetics

Balanced and responsible information in all things…