FDA

Deadly Botox? 16 Dead After Injections

Thursday, July 31, 2008 by: David Gutierrez, staff writer
Tags: botox, health news, Natural News

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(NaturalNews) At least 16 people have died after the botulinum toxin in a Botox injection spread to other parts of their bodies, according to FDA records.

The deaths are cited in a petition by the group Public Citizen to have a "black box" warning about this risk placed on the packaging of Botox and related medications. A black box is the strongest type of warning the FDA can put on a product without withdrawing it from the market.

Allergan's Botox and Solstice Neuroscience's Myobloc are among the injections based on the botulinum toxin, which blocks nerve impulses from reaching muscles, causing them to relax. Both medications are approved for use in treating cervical dystonia, a health condition that leads to rigid or spastic neck muscles. More famously, Botox is also approved for use in smoothing away wrinkles in the face.

According to Public Citizen's review of 180 reports of adverse effects reported to the FDA, at least 87 people have been hospitalized and 16 killed due to a spread of the toxin beyond the injection site. Side effects of the toxin include muscle weakness, trouble swallowing, or even aspiration pneumonia.

Four of the people who died from the injections were children.

While the prescribing instructions for both medications mention the risk that botulinum toxin can spread and paralyze other parts of the body, the warnings are easy to miss, said Sidney Wolfe, director of the Public Citizen Health Research Group. To decrease the risk of fatal incidents, Public Citizen says, the FDA needs to highlight the risk with a black box warning and require doctors to hand out an easy-to-understand guide to patients before administering the injections.

"These significantly improved warnings to doctors and patients would increase the likelihood of earlier medical intervention when symptoms of adverse reactions to botulinum toxin first appear, and could prevent more serious complications, including death," the FDA reads.

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