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Safety Becomes Important Focus In Light of Recent Deaths Resulting from Compounded Topical Anesthetics

(press release from the ASDS)

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ROLLING MEADOWS, Ill., -- The use of non-FDA approved compounded topical anesthetics has been drawn into sharp relief as physicians and spa owners responded to the news of at least two deaths attributed to the use of these unregulated products. The reported incidents involved two young women who used compounded topical anesthetics without physician supervision prior to undergoing routine laser hair removal.

According to New York City dermasurgeon Rhoda S. Narins, M.D., president of the American Society for Dermatologic Surgery, “Due to the proliferation of spas, salons and walk-in clinics offering cosmetic procedures performed by non-physicians, there has been an increase in the number of patient complications. Patient safety should always be the primary focus. Patients tend to focus on the ‘before and after’ results of cosmetic procedures, but as trained dermatologic surgeons we must be focused primarily on patient safety, as well as producing great results.”

Dermasurgeons have been using topical anesthetics safely and effectively to help manage the discomfort associated with certain cosmetic procedures for many years. Based on a reputation of safety and efficacy lidocaine 4% has traditionally been the gold standard in topical anesthetics. However, there has been a recent trend toward using very powerful topical anesthetics that are compounded at local pharmacies. These compounded topical anesthetics are not FDA-approved and have recently been linked to the deaths of two women. The unsupervised use of compounded topical anesthetics puts patients at unnecessary risk of significant adverse reactions, including fatality.

Dermasurgeon, Tina Alster, M.D., director of the Washington Institute of Dermatologic Laser Surgery in Washington D.C., emphasized that “Dermatologists who have affiliations with medical spas that offer waxing and laser hair removal services need to be especially aware of counseling clients in the correct use of lidocaine-based products prior to the service being performed. They need to spend time on site counseling the spa's staff with regard to preparing clients for hair removal procedures to ensure that accidents of the kind that produced these two tragic deaths are not repeated.”

Dr. Alster goes on to say that dermatologists should be advised to use only 4% lidocaine for cosmetic/beauty procedures and, if another higher strength topical preparation is used prior to a procedure, it should be used in small quantities. Dr. Narins agrees and adds that occlusion of an anesthetic over large areas should never be done.

In 2001 an FDA commission conducted a limited survey of drugs compounded by a group of community pharmacies located throughout the United States. It revealed that 34% of the compounded products surveyed failed one or more standard quality tests.

“As a result of the lack of FDA-regulated manufacturing standards, safety data, and guidelines for appropriate use, these compounded products present an increased risk of potential complications to the patient, including significant systemic adverse reactions. And because compounding pharmacies are not required to report adverse reactions to the FDA, the actual number of patient complications may be much greater than we currently know.” said Dr. Narins. She recommend that compounded anesthetics should only be used under direct physician supervision.

Although not indicated for use prior to cosmetic procedures, topical lidocaine 4% has become the gold standard in topical pain control based on well-established clinical findings of safety and efficacy. Nevertheless, Dr. Alster cautions, physicians who are associated with medispas and other healthcare professional should always use topical lidocaine 4% products at their discretion, because these uses are considered "off-label." They should also have a well-trained staff member on hand to ensure appropriate application. “A physician should always be on site,” stresses Dr. Narins.

Both the deaths that were reported were directly linked to the use of non-FDA approved compounded topical anesthetics sometimes referred to as “B.L.T.” (compounds consisting of various concentrations of benzocaine, lidocaine and tetracaine). Both women had applied the mixture to their legs and occluded them with cellophane wrap prior to laser hair removal.  


With more than 4,200 members, the American Society for Dermatologic Surgery, founded in 1970, is the largest specialty organization in the world exclusively representing dermasurgeons – board-certified physicians who are specifically trained to treat the health, function and appearance of the skin and soft tissue with both medically necessary and cosmetic procedures, using both surgical and non-surgical methods. For more information on medical or cosmetic skin procedures, and the safe use of topical lidocaine 4%, contact the American Society of Dermatologic Surgeons at phone 847-956-0900 or log on at www.asds.net.

 

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