The American Society for Aesthetic Plastic Surgery Addresses the Safety of Botox
NEW YORK, NY (January 25, 2008) - On January 23rd, Public Citizen, a consumer group, filed a petition with the U.S. Food and Drug and Administration (FDA) requesting labeling changes for botulinum toxins marketed in the United States.
Decades of use and recorded studies in peer-reviewed journals have documented the safety of BOTOX. The American Society for Aesthetic Plastic Surgery (ASAPS), the leading organization of board-certified plastic surgeons who specialize in cosmetic surgery of the face and body, emphasizes that Botox has been approved by the FDA as a Biologic Drug and, as with any medical treatment, patients should be fully informed as to the approved and off-label uses of the drug, as well as the benefits and risks of the procedure.
Since its FDA-approval for multiple neurological uses in 1989, Botox has been used millions of times. Widely tested over two decades, Botox has an excellent safety record. On April 15, 2002, the U.S. Food and Drug Administration (FDA) approved Botox for the treatment of moderate to severe glabellar frown lines (vertical creases between the brows). Other cosmetic uses of botulinum toxin continue to be off-label - that is, used at the physician's discretion with patient informed consent.
"As plastic surgeons committed to the safety and welfare of our patients, we have a great deal of interest and significant expertise informing patients about intended use of Botox and other aesthetic products," says Foad Nahai, MD, president of the American Society for Aesthetic Plastic Surgery (ASAPS). "We believe that the safety references in the petition are already satisfactorily addressed in the manufacturer labeling with detailed information and guidance, including approved indications, contraindications, warnings, drug interactions, precautions, and reported adverse event information. We believe that the product is safe and efficacious and we recommend its continued use as indicated.
All procedures have the potential for adverse events and complications associated with them. It is important for physicians to have a proper medical history of patients prior to them receiving any treatment. Patients should be fully informed and educated about risks and benefits.
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; active members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International active members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.
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