Jan 24, 2008 7:58 pm US/Eastern
Consumer Group Approaches FDA Over Botox Deaths
Black Box Warning, Medication Guide From Docs Wanted
Reporting
Cindy Hsu
NEW YORK (CBS) ―
Here's a warning for anyone who gets Botox.
After several people died from the injections, including children, a group is calling on the Federal Drug Administration to take action.
The consumer group Public Citizen says from 1997 to 2006 16 people died from Botox injections, four of them under the age of 18.
Dr. Sydney Wolf says many patients aren't warned about the symptoms to look for when something goes wrong.
"The early warning signals are difficulty swallowing, difficulty breathing, dry mouth and that's when the patient needs to go for emergency medical help," Wolf said. "No one should be dying from Botox, and the fact that they're dying means patients and doctors are not adequately being warned about it."
The group wants the FDA to label the products with a black box warning, the strongest warning the agency can make and require the doctors to give their patients a medication guide warning them about adverse reactions.
Of the 16 deaths, only one of them was from Botox used for cosmetic reasons.
"These things that happen in this report are pretty rare and wouldn't probably occur with cosmetic injections to the face, and more are specifically related to the injections in the neck," plastic surgeon Jennifer Levine said.
Levine says in the United States Botox is most commonly used for cosmetic reasons, but it's also used for:
* Neck and shoulder contractions
* crossed eyes
* Excessive underarm sweating
Levine says the closer the injections come to the esophagus, the riskier the procedure.
The report also found that 658 patients suffered adverse effects from Botox and 87 of them had to be hospitalized.
Levine says cosmetic Botox is relatively safe if you have a good doctor, but says as the use of Botulin toxin increases so does the risk for complications.
The FDA would not comment on the report.
WCBSTV.com's Most Popular Pages
Slideshow: World's Most Bizarre Deaths
Slideshow: 100 Greatest Movies Of All Time
Slideshow: The Coolest Fighter Jets…Ever!
Slideshow: Lindsay Lohan Grows Up, Or Does She?
Slideshow: Celebrity Sex Tapes Revealed
(© MMVIII, CBS Broadcasting Inc. All Rights Reserved.)
