SCHAUMBURG, Ill. (April 30, 2009) —
The American Academy of Dermatology (Academy) today issued a statement in response to the U.S. Food and Drug Administration's (FDA) announcement that a boxed warning will be added to the labeling of botulinum toxin products and a medication guide will be distributed to patients receiving these products for any use. These products are FDA-approved for the treatment of frown lines between the eyebrows and severe underarm sweating (hyperhidrosis).
"The health, safety and welfare of our patients being treated with botulinum toxin products are of paramount importance to dermatologists," said dermatologist David M. Pariser, MD, president of the American Academy of Dermatology. "While no serious side effects have been reported from the dermatologic use of botulinum toxin products, the FDA's actions emphasize the importance of selecting a qualified physician to administer these products for medical and cosmetic uses."
The Academy recommends that before receiving a treatment with botulinum toxin, patients should ask the following questions:
◦Is the treatment being performed by a physician experienced in this procedure?
- What results can be expected?
- How long is the recuperation period? Ask to see before and after photos of the physician's previous patients.
- What are the risks?
- Where is the procedure usually performed?
- What is the cost?
"The added precautions required by the FDA will provide patients with information to make the best decisions for their personal health," stated Dr. Pariser. " It also will help physicians ensure that patient safety is preserved."
For more information, please visit the Frequently Asked Questions About the FDA's Action on Botulinum Toxin.
The American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 15,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at 1-888-462-DERM (3376) or www.aad.org.