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By Michelle Meadows
Shiri Berg was a 22-year-old college student who wanted to have hair removed from her legs without too much pain. According to Food and Drug Administration records, a spa gave her a topical anesthetic product and instructed her to spread it over her legs before coming in for a laser hair removal procedure. Berg also was advised to wrap her legs in cellophane to intensify the numbing effect. While driving to her appointment in December 2004, she felt ill and pulled over. She then had seizures in her car and went into a coma. Berg, who attended North Carolina State University, never regained consciousness. She died several days later in January 2005.
The product Berg used contained 10 percent lidocaine and 10 percent tetracaine, two drug ingredients that provide pain relief by blocking signals at nerve endings in the skin. It was a prescription product, and Berg received no written instructions or warnings, according to FDA records.
Blanca Bolanos of Tucson, Ariz., died under similar circumstances, according to a 2005 report by "ABC News." Bolanos was a 25-year-old student at a community college when she was instructed to apply a topical anesthetic product to her legs and wrap them in cellophane before an appointment for laser hair removal in 2002. On her way to the clinic, she became disoriented, had seizures in her car, and went into a coma. Bolanos died in 2004 after being on a respirator for two years. The product Bolanos used contained 6 percent lidocaine and 6 percent tetracaine.
Both Berg and Bolanos received topical anesthetic products that were prepared by compounding pharmacies. "Some pharmacies promote these products to spas, cosmetic-service clinics, and doctors' offices," says Steve Silverman, assistant director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. In addition to being used for laser hair removal procedures, compounded topical anesthetic products have been used to lessen pain for tattoo applications and skin treatments.
"Compounded topical anesthetic products generally are not FDA-approved," Silverman says, "and these products may be dispensed to patients without appropriate precautions and explanations for use."
The FDA is concerned about firms that behave like illegal manufacturers, not traditional compounding pharmacies, because they produce standardized varieties of topical anesthetic creams. To this end, the agency notes that the drugs made by these firms do not appear to be uniquely tailored to meet the specialized medical needs of individual patients.
Moreover, the FDA is especially concerned when compounded drugs are dangerous to health. Exposure to high concentrations of some local anesthetics can cause seizures, irregular heartbeats, and other serious reactions. "The risks are even greater when different anesthetics are combined into one product," according to Silverman. Small children and others with pre-existing heart disease or severe liver disease are especially susceptible, Silverman says. The potential harm may increase if the anesthetic is left on the body for long periods of time or applied to broad areas of the body, particularly if an area is then covered by a bandage, plastic, or other dressing.
According to FDA records, the product sold to Berg, LaserPlus 10/10, was prepared by Triangle Compounding Pharmacy in Cary, N.C. The product sold to Bolanos, Photocaine Gel, was prepared by University Pharmacy in Salt Lake City.
In December 2006, the FDA warned Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal's Compounding Pharmacy, and New England Compounding Center to stop compounding and distributing standardized versions of topical anesthetic products. "This is different from traditional pharmacy compounding, in which the decision to create a specialized medication is driven by the physician, and the medication is intended to respond to the unique medical needs of individual patients," Silverman says.
Virtually all compounded drugs lack FDA approval, but the FDA has long recognized the important public health function served by traditional pharmacy compounding. In traditional compounding, pharmacists extemporaneously combine, mix, or alter drug ingredients to create a medication tailored to the specialized needs of a patient. For example, a compounding pharmacy might prepare a unique medicine for someone who is allergic to an ingredient in an FDA-approved drug.
This kind of compounding, which is done in accordance with a valid prescription from a licensed practitioner, follows a physician's decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs. The FDA understands the benefits of traditional pharmacy compounding and is not targeting this practice.
By contrast, the FDA is concerned that the five firms that received Warning Letters are producing standardized versions of topical anesthetic products for general distribution, which is opposite to the notion that patient-specific treatment underlies traditional compounding. Firms that don't resolve violations in FDA Warning Letters risk enforcement such as injunctions against continuing violations and seizure of illegal products.
There are FDA-approved topical anesthetic products that are commercially available, properly labeled, and regularly used in health care settings. "The problem is when pharmacies create their own versions, without medical need, and those products reach consumers without appropriate warnings or directions for use," Silverman says.
Consumers and health professionals should notify the FDA of any complaints or problems associated with compounded drugs, including compounded topical anesthetic products. These reports may be made to MedWatch, the FDA's voluntary reporting program, at www.fda.gov/medwatch/report.htmor by telephone at (800) FDA-1088 (332-1088).
The FDA's Center for Devices and Radiological Health regulates electrolysis equipment and lasers. Chemical depilatories, waxes, and shaving creams and gels fall under the jurisdiction of the FDA's Office of Cosmetics and Colors in the Center for Food Safety and Applied Nutrition. The practice of professional hair removal is generally regulated by state and local authorities. Here are some tips related to common methods of hair removal.
In this method, a laser destroys hair follicles with heat. Lasers are prescription devices that should be used only under the direction of a licensed practitioner. If a topical anesthetic product is recommended before a laser hair removal procedure to minimize pain, the FDA recommends that consumers discuss the circumstances under which the cream should be used with a medical professional, and whether the use is appropriate. Those who decide to use a skin-numbing product should follow the directions of a health care provider and consider using a product that contains the lowest amount of anesthetic drugs possible. The FDA's Center for Drug Evaluation and Research has received reports of serious and life-threatening side effects after use of large amounts of skin-numbing products for laser hair removal. Side effects of laser hair removal can include blistering, discoloration after treatment, swelling, redness, and scarring. Sunlight should be avoided during healing after the procedure.
Needle epilators introduce a fine wire close to the hair shaft, under the skin, and into the hair follicle. An electric current travels down the wire and destroys the hair root at the bottom of the follicle, and the loosened hair is removed with tweezers. Medical electrolysis devices destroy hair growth with a shortwave radio frequency after a thin probe is placed in the hair follicle. Risks from these methods include infection from an unsterile needle and scarring from improper technique. Electrolysis is considered a permanent hair removal method, since it destroys the hair follicle. It requires a series of appointments over a period of time. Tweezer epilators also use electric current to remove hair. The tweezers grasp the hair close to the skin, and energy is applied at the tip of the tweezer. There is no body of significant information establishing the effectiveness of the tweezer epilator to permanently remove hair.
Available in gel, cream, lotion, aerosol, and roll-on forms, depilatories are highly alkaline (or, in some cases, acidic) formulations that affect the protein structure of the hair, causing it to dissolve into a jellylike mass that the user can easily wipe from the skin. Consumers should carefully follow instructions and heed all warnings on the product label. For example, manufacturers typically recommend conducting a preliminary skin test for allergic reaction and irritation. Depilatories should not be used for eyebrows or around eyes or on inflamed or broken skin. The FDA's Office of Cosmetics and Colors has received reports of burns, blisters, stinging, itchy rashes, and skin peeling associated with depilatories and other types of cosmetic hair removers.
Unlike chemical depilatories that remove hair at the skin's surface, these methods pluck hairs out of the follicle, below the surface. With waxing, a layer of melted wax is applied to the skin and allowed to harden. (Cold waxes, which are soft at room temperature, allow the user to skip the steps of melting and hardening.) It is then pulled off quickly in the opposite direction of the hair growth, taking the uprooted hair with it. Labeling of waxes may caution that these products should not be used by people with diabetes and circulatory problems. Waxes should not be used over varicose veins, moles, or warts. Waxes also shouldn't be used on eyelashes, the nose, ears, or on nipples, genital areas, or on irritated, chapped, or sunburned skin. As with chemical depilatories, it can be a good idea to do a preliminary test on a small area for allergic reaction or irritation. Sugaring is similar to waxing. A heated sugar mixture is spread on the skin, sometimes covered with a strip of fabric, and then lifted off to remove hair. Threading is an ancient technique in which a loop of thread is rotated across the skin to pluck the hair. All of these techniques may cause skin irritation and infection.
Shaving hair only when it's wet, and shaving in the direction in which the hairs lie, can help lessen skin irritation and cuts. It's important to use a clean razor with a sharp blade. Contrary to popular belief, shaving does not change the texture, color, or growth rate of hair. Razors and electric shavers are under the jurisdiction of the Consumer Product Safety Commission.
FDA Public Health Advisory
www.fda.gov/cder/drug/advisory/topical_anesthetics.htm
Media reports on Berg and Bolanos
http://abcnews.go.com/Primetime/Health/story?id=692826&page=1
www.newsobserver.com/256/story/229886.html