Adverse Drug Reactions

AAFPRS Speaks to the Safety of BOTOX(R) Cosmetic

Published in Medical Letter on the CDC and FDA, March 2nd, 2008

In response to the recent news of the U.S. Food and Drug Administration (FDA) "Early Communication" regarding a safety review of botulinum toxins in the United States, the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) wants to make clear that the FDA's inquiry relates primarily to high dose medical uses of BOTOX(R), and not BOTOX(R) Cosmetic for aesthetic use.

BOTOX(R) (botulinum toxin type A) is indicated and used to treat a variety of often serious medical conditions, whereas BOTOX(R) Cosmetic is approved by the FDA for the aesthetic treatment of wrinkles between the brows and involves very different doses.

On February 8th,...

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Source: Medical Letter on the CDC and FDA (2008-03-02)

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