Beware Illegal Use of Wrinkle Reducer
(Ivanhoe Newswire) -- Before you try BOTOX or another botulinum toxin formulation to smooth those signs of aging, be sure you are receiving an FDA-approved formulation at the correct dose.
According to researchers from the Centers for Disease Control and Prevention, four patients in 2004 didn't and ended up with severe side effects. An investigation into the incidents reveals the patients were given an unlicensed version of the product at up to 43-times the normally fatal dose in humans.
The same physician treated three of the patients, and the fourth case was the physician himself. All received between four and six facial injections of the unlicensed product. Following treatment each of the patients developed signs of botulism, a toxic reaction characterized by increasing weaknesses and nerve damage, resulting in poor control of the facial muscles and swallowing. Two of the patients also developed shortness of breath.
"Physicians and patients must be aware of the hazards associated with illegitimate use of unlicensed botulinum toxin products," write the authors. "Only licensed products should be used clinically."
They suggest more federal oversight to ensure individual shipments of the medication are properly regulated. They also call for stricter controls on researchers who receive the product for investigative purposes, noting the product at fault in these cases was formulated for laboratory research only and never intended for use in people.
This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.
SOURCE: The Journal of the American Medical Association, 2006;296:2476-2479