As far as cosmetic procedures go, Botox advertising makes the procedure sound about as routine as getting a haircut.
But the citizen's group, Public Citizen is now sounding a warning that Botox can cause serious injury and death.
Tiny amounts of the botulinum toxin type A is used to deaden muscles and diminish wrinkles between the forehead. It's also used off-label to stop sweating and address pain.
Public Citizen did a safety analysis of Botox procedures from FDA records covering 1997 to 2006. Altogether there were 658 adverse effects from injections. Among those included potentially life-threatening pneumonia and fluid in the lungs and difficulty swallowing. There were also 16 deaths.
The data comes from drug manufacturers, so Public Citizen believes the numbers could be much higher.
The watchdog group today petitioned the FDA to strengthen warning to doctors and patients about the risks of Botox. The group wants the FDA to send warning letters to doctors so they take seriously the safety risks and share those adverse effect potential with their patients. And they want a “black box” warning on the label- the strongest possible safety warning.
In 2003, the FDA warned maker Allergan that its ads were minimizing the risks of the botulinum toxin.
Today the Botox Web site has warnings posted and doctors say they already alert patients about possible adverse side effects.
Botox is only approved for injection between the eyebrows. Some doctors may be using it “off-label” elsewhere on the face. Other patients have had extremely adverse reactions when practitioners make up their own botulism toxin to save money and make more profit.
One couple was permanently disabled after their phony Botox injections.
"These significantly improved warnings...could prevent more serious complications, including death," said Dr. Sidney Wolfe, head of Public Citizen's Health Research Group. According to Wolfe, "Nobody should be dying from injected botulinum toxin.
Allergan, maker of Botox made no comment on the petition today.
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