American Society For Dermatologic Surgery Supports Current Labeling Of Allergan's Botox(R) Products

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

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The American Society for Dermatologic Surgery (ASDS), a 5,000 member specialty organization of leaders in the field of cosmetic and medically necessary skin surgery, is aware of the petition filed by Public Citizen with the U.S. Food and Drug Administration (FDA) regarding Allergan's Botox products. The ASDS supports the current labeling of all Botox(R) products for its intended use by trained physicians, believes that there is no data to support additional labeling warnings and therefore disagrees with the petition filed by Public Citizen.

Since its development in 1989, Botox(R) products have had a safe 19-year track record and have been successfully used on more than 1 million patients throughout the United States. In addition, in 2005 ASDS members successfully administered Botox(R) products to more than 575,000 patients. Patient safety is a cornerstone of ASDS policy and the Society believes that current data supports the continued safe use of this product with no change in labeling necessary.

"The ASDS fully supports the current labeling of all Botox(R) products, as we believe current labels responsibly include detailed directions for approved medical uses, warnings, precautions, drug interactions and reported adverse information. Furthermore, we have observed that Allergan has cooperated with the FDA to ensure proper labeling for this product and provided physicians with the appropriate information to use Botox(R) effectively," says Darrell S. Rigel M.D., president of the ASDS. "Therefore, ASDS members will remain confident of its safe and effective results, and will continue to administer Botox(R) to our patients where appropriate."

The American Society for Dermatologic Surgery
http://www.asds.net