Wednesday, April 9, 2008
Group Wants Botox Warning After Deaths
Botox and a similar injection should come with strong warnings following reports of 16 deaths and other serious problems after the botulinum toxin spread inside the body, a U.S. consumer group said on Thursday.
Public Citizen asked U.S. authorities to require the strongest possible warning, highlighted in a "black box," on Allergan Inc's Botox and Solstice Neuroscience Inc's Myobloc.
Botox is famous for smoothing facial wrinkles but also has approved medical uses such as treating cervical dystonia, or rigid neck muscles. Myobloc is cleared only for the neck condition.
Both injections are made with forms of the botulinum toxin, which can paralyze muscles.
Public Citizen said it reviewed 180 reports submitted to the Food and Drug Administration by manufacturers involving patients injected with Botox or Myobloc. The reports detailed cases of muscle weakness, difficulty swallowing or aspiration pneumonia, a serious condition caused by breathing a foreign material into the lungs.
Reports to the FDA do not prove a product caused a particular problem, but the agency uses them to look for patterns of potential complications.Read more..
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