Can Botox Kill?
A public interest group is petitioning the Food and Drug Administration to increase the warnings on the popular cosmetic and drug Botox.
Dr. Sidney Wolfe of Public Citizen Health Research Group said severe reactions, including deaths, have been linked to the product.
Botox and another drug, Myobloc, use botulinum toxin, which blocks nerve impulses to muscles, causing them to relax.
But in a few cases, the toxin has spread to other parts of the body, resulting in problems including paralysis of respiratory muscles and difficulty swallowing, potentially leading to food or liquids entering the lungs and causing aspiration pneumonia, Wolfe said.
Public Citizen sought so-called black box warnings on both products.
"What we're saying is, nobody should be dying of Botox, and they wouldn't be dying if the government and the companies were doing a better job warning people," Wolfe said to Early Show
co-anchor Maggie Rodriguez Friday.
Botulinum toxin is approved for such uses as easing muscle spasms and crossed eyes. Botox is also approved for one cosmetic use treatment of wrinkles between the eyebrows.
Botox maker Allergan did not immediately respond to requests for comment on the petition.
According to the petition, there have been 180 reports of adverse effects in the United States, including 16 deaths, with four children among the fatalities.
While the possibility of dangerous side effects is noted in the detailed information available for the products, that isn't always available to the public.
The enhanced warnings would make people aware of the possibility of side effects, so they could seek emergency medical help if they experienced early symptoms such as dry mouth, difficulty swallowing, difficulty breathing, slurred speech, drooping eyelids and muscle weakness, Public Citizen says.
"In Britain and in Germany, letters were sent out last year to every doctor, warning them about the early signs of problems," Wolfe told Rodriguez.