The American Society of Plastic Surgeons (ASPS) addressed concerns regarding the use of botulinum toxin products and adverse events following a recent petition from a consumer group.
On January 23, public citizen requested the FDA implement labeling changes and a written communication to physicians.
"As patient advocates, plastic surgeons are primarily concerned about the safety of our patients," says Richard A. D’Amico, MD, ASPS president. "We have a keen interest and expertise in informing patients about intended use of the product and risks and benefits."
ASPS believes that the safety issues identified in the petition are currently addressed in the manufacturer labeling with detailed information and guidance, including approved indications, contraindications, warnings, drug interactions, precautions, and reported adverse event information.
The ASPS works closely with the FDA on a range of issues and strongly supports existing labeling requirements agreed to between the manufacturers and the FDA.
Almost all drugs and devices have 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.
ASPS will continue to work closely with the FDA and manufacturers on an ongoing basis regarding physician and patient education.
[www.medicalnewstoday.com, January 28, 2008]