Botox Danger

The U.S. consumer advocacy group, Public Citizen, has called upon authorities to require that Botox and a similar injections come with strong warnings following reports of 16 deaths and other serious problems after the botulinum toxin spread inside the body. 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 used widely to decrease 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 are made with forms of the botulinum toxin, which can paralyze muscles.
Public Citizen 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.
Sixteen of the cases reported were fatal, including four involving children under 18, Public Citizen said. Some patients were hospitalized.
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said such problems can occur if toxin spreads from the injection site to the esophagus, causing partial paralysis. Instructions for Botox and Myobloc mention the issue but it is easy to miss, he said. He called for the increased warnings to physicians and consumers.