“Black-box warning” ordered for Botox

Anti-wrinkle drugs must carry serious warning label, FDA says

Botox and similar anti-wrinkle drugs will now come with a “black-box warning,” one of the strongest safety actions the US Food and Drug Administration can take. Such labels are typically used on medications with serious or life-threatening risks (for example, antidepressants carry such warnings due to an increased danger of suicidal thoughts and actions). The labels on Botox and similar drugs will warn they can spread from injection site to other parts of the body, the New York Times reports, which can cause serious problems including difficulties swallowing or breathing. The FDA issued its order the day after it approved a new drug expected to be Botox’s first rival in the US: Dysport, an injectable drug made from the botulinum toxin, which has been available in Europe for years at a price point lower than Botox. According to Dr. Ellis F. Unger of the FDA, botulinum toxins are safe when used at approved doses for approved uses.

The New York Times

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