The American Society For Aesthetic Plastic Surgery Addresses The Safety Of Botox

Main Category: Cosmetic Medicine / Plastic Surgery
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 28 Jan 2008 - 0:00 PDT

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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(R). 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.

About ASAPS

The 2400-member American Society for Aesthetic Plastic Surgery (ASAPS) is the only plastic surgery organization devoted entirely to the advancement of cosmetic surgery. ASAPS is recognized throughout the world as the authoritative source for cosmetic surgery education. U.S. members are certified by the American Board of Plastic Surgery. Canadian members are certified in plastic surgery by the Royal College of Physicians and Surgeons of Canada. The Society receives educational grants from Industry.

The American Society for Aesthetic Plastic Surgery
http://www.surgery.org