Concerns About Botox

After reviewing reports of 16 deaths related to Botox, a U.S. consumer group has asked authorities to require the strongest possible warning on the label. Botox is famous for smoothing facial wrinkles, but also has been approved for medical uses such as treating cervical dystonia, or rigid neck muscles. The medication is made with forms of the botulinum toxin, which blocks nerve impulses to muscles and makes them relax.

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. Reports to the FDA do not prove a product caused a specific problem, but the agency uses them to look for patterns of potential complications. Experts believe most problems are under-reported to the agency.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said problems can occur if botulinum toxin spreads from the injection site to other places in the body such as the esophagus. Public Citizen asked the FDA to order a black-box warning to highlight concerns. The agency was also asked to require a consumer-friendly guide explaining the risks that would be handed out by doctors when the drug is injected, the group said. FDA spokeswoman Karen Riley said the agency would not comment while the Public Citizen petition was under review.