NEW YORK, NY (February 12, 2008) —Heading 1 + 11 pt, Not Bold In response to the recent news of the U.S. Food and Drug Administration (FDA) “Early Communication” regarding a safety review of botulinum toxins in the United States, the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) wants to make clear that the FDA’s inquiry relates primarily to high dose medical uses of BOTOX®, and not BOTOX® Cosmetic for aesthetic use.
BOTOX® (botulinum toxin type A) is indicated and used to treat a variety of often serious medical conditions, whereas BOTOX® Cosmetic is approved by the FDA for the aesthetic treatment of wrinkles between the brows and involves very different doses.
On February 8th, the FDA announced it was reviewing certain serious adverse events following the use of botulinum toxins, particularly for the management of juvenile cerebral palsy. However, the FDA made clear in its communication that “the posting of this information does not mean that there is a causal relationship between the products and the adverse events.”
The AAFPRS further clarifies that the adverse side effects under investigation by the FDA occurred in children with cerebral palsy where the therapeutic benefit of using Botox® was achieved in doses that were 15-20 times the dose used for cosmetic purposes.
“In all of the years Botox® Cosmetic has been used for cosmetic purposes, there have been no reported deaths linked to its use,” says Vito Quatela, president of the AAFPRS. “With all of our members’ combined experience with the drug, we are confident that the product is safe, effective and recommend its continued use as indicated. The FDA has been clear that it is not recommending discontinued use of BOTOX® Cosmetic and that there is no defect with the drug.”
The AAFPRS reminds patients and professionals that all facial plastic and reconstructive surgeries should be performed by a board certified and experienced facial plastic surgeon. The AAFPRS cautions that all procedures have the potential for adverse events and complications. Physicians should have a proper medical history of a respective patient prior to treatment. Patients should be fully informed and educated about benefits and risks.
The American Academy of Facial Plastic and Reconstructive Surgery is the world’s largest specialty association that represents over 2,700 facial plastic and reconstructive surgeons throughout the world. The AAFPRS is a National Medical Specialty Society of the American Medical Association (AMA), and holds an official seat in both the AMA House of Delegates and the American College of Surgeons board of governors. AAFPRS members are board certified surgeons whose focus is surgery of the face, head, and neck. In addition, the AAFPRS provides consumers with free information and brochures and a list of qualified facial plastic surgeons in their area by visiting the AAFPRS Web site, www.aafprs.org.