<b>Botox warning after 16 death reports</b>
Botox and a similar injection called Myobloc should come with stronger warnings following reports of 16 deaths after the botulinum toxin spread inside the body, a U.S. consumer group warned recently.
Botox (Type A botulinum toxin) is famous for smoothing facial wrinkles but also has approved medical uses such as treating cervical dystonia, or rigid neck muscles and in some other conditions. FDA approved another injection Myobloc (type B toxin) to treat cervical dystonia and has also been used to remove facial wrinkles.
Both injections are made with forms of the botulinum toxin, which blocks nerve impulses to muscles and makes them relax.
Public Citizen said it reviewed 180 reports submitted to the Food and Drug Administration (FDA) 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. Experts believe most problems are under-reported to the agency.
Sixteen cases reported to the FDA were fatal, including four involving children under 18, Public Citizen informed. Eighty-seven patients were hospitalised.
Dr Sidney Wolfe, director of Public Citizen's Health Research Group, said such problems can occur if botulinum toxin spreads from the injection site to places such as the esophagus, causing partial paralysis. Instructions for Botox and Myobloc mention the issue but it is easy to miss, he expressed.
Public Citizen asked the FDA to order a black-box warning to highlight the concern, plus a letter to doctors. The agency also should require a consumer-friendly guide explaining the risks that would be handed out by doctors when the drug is injected, the group said.
"These significantly improved warnings to doctors and patients would increase the likelihood of earlier medical intervention when symptoms of adverse reactions to botulinum toxin first appear, and could prevent more serious complications, including death," Public Citizen said in a petition to the FDA.
Early symptoms include dry mouth, difficulty breathing or swallowing, slurred speech, drooping eyelids and muscle weakness.
For all latest news, follow The Daily Star's Google News channel.
Comments