Body, Bath & Beauty Blog

FDA Issues New Warning On Botox

Posted on: May 1, 2009

In an article in the New York Times today, Natasha Singer reports that the FDA has ordered the strictest of all warning labels for Botox and similar anti-wrinkle drugs.

“The F.D.A. said such drugs must carry warning labels explaining that the material has the potential to spread from the injection site to distant parts of the body — with the risk of serious difficulties, like problems with swallowing or breathing.

Requiring a drug to carry a box with bold-face risk information — a so-called black-box warning — is one of the strongest safety actions the F.D.A. can take. Black boxes are typically reserved for medications known to have serious or life-threatening risks.”

This comes the day after the FDA approved another anti-wrinkle drug, Dysport.

“The agency’s approval of Dysport, manufactured by Ipsen, based in Paris, portends a fierce competition in the United States toxin market of a sort that has been raging in Europe for years.”

Botox is not only used for treating frown lines, but also used in treating “crossed eyes, eyelid spasms, severe underarm sweating, and cervical dystonia, a neck problem that can cause severe pain and abnormal head position,” as well as cervical dystonia.

To read the full article from the New York Times click here.

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