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Warnings for makers of compounded pain products.

Article Excerpt
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...

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