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Beauty Byte: FDA Orders "Black Box" Warning For Botox

Beauty Byte: FDA Orders "Black Box" Warning For Botox


The black box warning is one of the strongest safety actions the FDA can take . . . and it has come to Botox. Reserved for medications with known serious or life-threatening dangers, the change requires printed bold-face risk information in a black border. Not only does this increase awareness for the adverse effects, but treatment is now accompanied by a medication guide for patients at the time of toxin injection (presumably with even more warnings about this cosmetic treatment).

The decision was made on the heels of a newly approved drug, Dysport, expected to be the first real challenger to the Botox Cosmetic drug. Both are derived from the agent botulinum toxin – purified forms of the bacterial poison that causes botulism – a potentially fatal disease. These drugs temporarily reduce or halt (aka paralyze) muscle activity near the injection spot . . . but reports claim those problems can also spread to other body parts. Now, I know the choice is yours — but does a new labeling requirement change your view on this treatment?

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