Consumer Group Calls for Stronger Warnings on Potential Dangers of Botox
Watchdog group says its analysis shows Botox can cause serious injury and death.
Jan. 24, 2008— -- A leading consumer watchdog group says its safety analysis revealed that the use of Botox can potentially cause serious injury and death. As a result, Public Citizen today petitioned the Food and Drug Administration to immediately strengthen health warnings to doctors and patients about the risks of using botulinum toxin products, the most commonly known of which is Botox.
While botulinum toxin is highly toxic, minute quantities of the substance have been widely used for therapeutic and cosmetic procedures.
Public Citizen said an analysis of FDA data showed that from 1997 to 2006 there were 658 cases of patients experiencing adverse effects after being injected with the botulinum toxin. The consumer group said 180 of these patients suffered from potentially life-threatening conditions, including pneumonia, difficulty swallowing and fluid in the lungs. According to the analysis, there were 16 deaths associated with the use of the toxin. Because the data was self-reported by drug manufacturers, Public Citizen estimated the numbers only account for 10 percent of all cases.
Public Citizen's petition calls for the FDA to strengthen existing warnings about the potential health risks associated with use of the botulinum toxin. Specifically, the petition asks the FDA to send letters to doctors alerting them of all safety risks and would require doctors to provide patients with information about possible adverse effects. The FDA would also be required to include the strongest possible safety warning on botulinum toxin products -- a so-called "black box" label.
"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. Educating physicians and patients about what adverse symptoms to look for and when to seek immediate medical attention will save lives."
The FDA said it could not comment on Public Citizen's petition while it is under consideration. Allergan, the U.S. manufacturer of Botox, was unavailable for comment.
Currently, U.S. doctors voluntarily inform patients of possible adverse effects from the use of botulinum toxin. New York City plastic surgeon Dr. Jennifer Walden said she performs routine Botox treatment on 10 to 15 patients each week. Walden said she requires her patients to undergo a comprehensive explanation about the procedure and complete a consent form, detailing the drug's possible adverse effects before she will treat them.
"We do an informed consent process that goes over all the possible complications from the injection of Botox," said Walden.
Walden, however, said a potential concern is when doctors inject Botox for "off-label" uses. For cosmetic procedures, Botox is only approved for injection betweem the eyebrows. Walden said doctors who are not properly trained in facial anatomy could inject Botox in unsafe areas of the body.
According to Walden, "If they don't know what they're doing, they could inject into the trachea or the muscles you need for swallowing. So that's a danger."