A Black Box for Botox?

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In a move likely to be protested by TV anchorwomen and medi-spas everywhere, the consumer group Public Citizen has petitioned the Food and Drug Administration to place a black box warning label on Botox indicating that the popular anti-wrinkle treatment can be deadly. The FDA has received reports of at least 16 Botox-related deaths, including four in children under 18, as well as 180 cases of serious adverse reactions to the drug.

The adverse reactions are much worse than a few laugh lines. The botulism toxin, which smooths wrinkles by relaxing muscles, occasionally migrates far beyond the creased brow. Botox can paralyze the respiratory muscles or cause difficulty in swallowing, a problem that leads to food and liquids lodging in the lungs and causing life-threatening pneumonia.

European regulators have already widely publicized the risk, but the FDA has been slow to react, leaving Americans blissfully ignorant about the perils of vanity and doctors free to administer the drug for all sorts of unapproved uses. (The only cosmetic use of Botox approved by the FDA is for smoothing wrinkles between the eyebrows.) While the new FDA data are striking, didn’t we all sort of know, deep down, that paralyzing your face with a deadly poison was probably a bad idea? Here’s hoping that Public Citizen helps make wrinkles fashionable again.

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