Watchdog warns of Botox risks
2008-02-09 09:07
Washington - The US drugs safety watchdog on Friday warned that using botulinum toxins such as the popular cosmetic treatment Botox can have serious side-effects including death, but stopped short of banning them.
"The FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins," the Food and Drug Administration (FDA) said.
"The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected.
"The most serious cases had outcomes that included hospitalisation and death," it added.
The side-effects occurred in child and adult patients using botulinum toxins to treat several different conditions, including spasms of the legs, eyelids or neck, the easing of facial lines, or excessive sweating.
The warning comes amid an ongoing review by the FDA of the safety of botulinum toxins, and two weeks after a consumer rights group urged that Botox, the toxin used by millions around the world to iron out wrinkles, carry more stringent health warnings.
Advocacy group Public Citizen, founded by former presidential candidate Ralph Nader, called last month for the FDA to "immediately increase its warnings ... about the use of botulinum toxin" because of "serious adverse reactions, including deaths, linked to the drug".
The group said that between November 1997 and December 2006 there were 16 deaths among the 658 reported cases of people "suffering adverse effects from injections of botulinum toxin."
The FDA insisted it has "not concluded there is a causal relationship between the drug products and the emerging safety issue" and was "not advising healthcare professionals to discontinue prescribing these products".
"FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action," it said on Friday.
The botulinum toxin is a natural poison found in decomposing food that is 40 million times more powerful than cyanide.
When injected, tiny doses of the toxin paralyze a muscle and prevent it from contracting for between four and six months - ideal for temporarily eliminating facial wrinkles but deadly if it affects the wrong muscles, such as the heart.