Botox Needs Strengthened Warning, Group Says

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January 25th, 2008

"Consumer Advocacy Group Seeks Increased Warnings on Botox"

The consumer advocacy group Public Citizen is seeking heightened warnings on Botox and a similar injectable over the risk of death and serious injury caused by spread of the drugs to vital organs.

According to the group, 16 deaths are associated with use of Botox and Myobloc, a similar drug made by Solstice Neurosciences. Four of those deaths occurred in children, and all but one were associated with medical use of the products.

Medical Use

Botox is a popular cosmetic wrinkle treatment, but it is also approved to treat a painful neck condition known as cervical dystonia. When injected into areas of the neck, Botox can relieve sometimes-disabling pain. The same is true of Myobloc.

However, injections of Botox and Myobloc to the condition are made extremely close to the esophagus, where the drugs may cause partial paralysis and lead to complications such as aspiration pneumonia, said Public Citizen.

“Nobody should die from the medical use of Botox. The fact that they are shows that patients don’t have a clue about these problems,” said Dr. Sidney Wolfe, director of health research for the group.

Petition Filed

Public Citizen filed a petition with the Food and Drug Administration on Thursday, asking the agency to require the manufacturers of the two products to strengthen their warning labels to detail the risks.

(Source: New York Times)

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