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FDA urged to press tougher warnings on Botox
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This undated file photo shows a person is receiving botulinum toxin injection. A public interest group has petitioned the U.S. authorities to press tougher warnings on wrinkle-eliminating cosmetic drug, media reported Monday. (file Photo)

 

A public interest group has petitioned the U.S. authorities to press tougher warnings on wrinkle-eliminating cosmetic drug, media reported Monday.

 

Public Citizen Health Research Group urged the U.S. Food and Drug Administration Thursday to immediately increase its warnings about the use of botulinum toxin because serious adverse reactions, including deaths, were found linked to the drug.

 

The toxin is sold under the commercial names of Botox, Myobloc and Dysport.

 

In its petition, the group said although detailed information about the possible serious side effects is noted, that is not always available to the public.

 

The group noted that U.S. authorities have approved the toxin for "a limited number of 'therapeutic' conditions, including uncontrollable neck and shoulder muscle contractions, spasmodic blinking of the eyes and excessive underarm sweating.

 

 

"The only approved cosmetic use is for temporary smoothing of wrinkles between the eyebrows. Most cosmetic uses of botulinum toxin are unapproved," said Dr. Sidney Wolfe of the group.

 

Botulinum toxin, a natural poison found in decomposing food, is 40 million times more powerful than cyanide.

 

In some cases, the toxin had spread to other parts of the body with serious consequences, such as paralysis of respiratory muscles and difficulty swallowing, which was likely to lead to food or liquids entering the respiratory tract and lungs, causing aspiration pneumonia, Wolf???? said.

 

About 16 deaths were reported between November 1997 and December 2006, along with more than 600 people suffering adverse effects from injections of botulinum toxin.

 

(Agencies via Xinhua January 28, 2008)

 

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