U.S. group seeks Botox warning after 16 death reports

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, according to consumer group Public Citizen.

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. Sixteen of the cases reported were fatal, including four involving children under 18, Public Citizen said.

Problems can occur if botulinum 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.