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The American Society For Aesthetic Plastic Surgery Addresses The Safety Of Botox
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
View drug information on Botox Cosmetic.
A societãþii americane din material plastic pentru chirurgie esteticã adrese de siguranþã de Botox - The American Society For Aesthetic Plastic Surgery Addresses The Safety Of Botox - articole medicale engleza - startsanatate