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US Activists Press for Tougher Warnings on Botox
Advocacy group Public Citizen, founded by former presidential candidate Ralph Nader, urged the Food and Drug Administration (FDA) on Thursday to "immediately increase its warnings ... about the use of botulinum toxin" because of "serious adverse reactions, including deaths, linked to the drug."
However neither Allergen Inc, the company that produces and sells Botox, nor the American Society for Dermatologic Surgery, which groups surgeons that use the product, believe further warnings are necessary.
The FDA "has not issued any warnings to patients or doctors about the dangers of using the toxin," the group, founded by consumer campaigner and former presidential candidate Ralph Nader, said in a statement.
The botulinum toxin is a natural poison found in decomposing food that is 40 million times more powerful than cyanide.
When injected, tiny dosages of the toxin paralyze a muscle and prevent it from contracting for between four and six months -- ideal for temporarily eliminating facial wrinkles.
The toxin is sold under the commercial names of Botox or Vistabel (Allergen Inc), Myobloc or Neurobloc (Solstice Neurosciences Inc.) and Dysport (Ipsen Ltd).
In its petition, Public Citizen notes that US authorities have approved the toxin for "a limited number of 'therapeutic' conditions, including uncontrollable neck and shoulder muscle contractions, crossed eyes, spasmodic blinking of the eyes and excessive underarm sweating.
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