In Wake of 16 Deaths, Advocates Urge FDA to Improve Botox Warnings

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Public Citizen Health Research Group has petitioned the Food and Drug Administration to increase the warnings on the popular cosmetic drug Botox.

Long parodied in popular culture, Botox and the similar drug Myobloc use botulinum toxin to block nerve impulses to muscles, causing them to relax (thereby giving the appearance of smoothed wrinkles). However, Public Citizen reports that in a few cases, the toxin has spread to other parts of the body, resulting in paralysis of respiratory muscles and difficulty swallowing. This can lead to fluids or foods entering the lungs.

Public Citizen's petition lists 180 reports of adverse effects in the United States from Botox, including 16 deaths. The group points out detailed info on potential side effects is not always given to consumers. They claim a so-called black box warning would make users more aware to seek help if they start to experience early warning signs.

On the same day as Public Citizen's petition, the New York Times had a review of Charla Krupp's book How Not to Look Old, running under the headline "Nice Résumé. Have You Considered Botox?"

Krupp, a former editor of Glamour and past guest on Oprah, wrote, "Looking hip is not just about vanity anymore, it's critical to every woman's personal and financial survival." The Times points out, "The book is the latest makeover title to treat the aging of one's exterior as a disease whose symptoms are to be fought to the death or, at least, mightily camouflaged."

Krupp told the Times, "I'll do Botox and Restylane injections, but my motto is, 'I won't go under.' I won't do anything that involves anesthesia."

With societal pressure this strong, it's doubtful even black box labels will discourage many from Botox.

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