Botox - A Deadly Drug? 16 Die After Being Injected

As reported by the FDA, the botulinum toxin, a primary ingredient in in Botox injections, has killed at least 16 people when the toxin spread to other parts of their bodies.

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. The highest warning level that the FDA can give a product without removing it from shelves is called a black box.

Botox made by Allergan and Myobloc from Solstice Neuroscience are a few of the injections that you can receive based on the botulinum toxin, which stops nerve impulses from getting to muscles, in turn making them relax. These two drugs are medically approved for the treatment of cervical dystonia, which often results in tough or spastic neck muscles. Botox is known by more people as a way to smooth out face wrinkles.

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. Public Citizen has said that the Food and Drug Administration should outline the risks with a block box warning while requiring doctors to also hand out a guide to patients before administering these 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 says.