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February 14, 2008

FDA links anti-wrinkle drugs to deaths

The Food and Drug Administration has linked botulism in some users to the anti-wrinkle drugs Botox Cosmetic and competitor Myobloc. Some cases have been so severe that a few children given the drugs for muscle spasms have died. In rare cases, the toxin can spread to other parts of the body, paralyzing or weakening the muscles used for breathing and swallowing, a potentially fatal side effect. Botox is best known for minimizing wrinkles by paralyzing facial muscles, but botulinum toxin is also widely used for a variety of muscle-spasm conditions, such as cervical dystonia or severe neck spasms. The FDA said the deaths it is investigating so far all involve children, mostly cerebral palsy patients being treated for spasticity in their legs. The FDA has never formally approved that use for the drugs, but some other countries have. However, the FDA warned that it also is looking into reports of illnesses in people of all ages who used the drugs, including at least one hospitalization of a woman given Botox for forehead wrinkles. The FDA wouldn't say exactly how many reports it is researching.

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