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.

The botulinum toxin has a number of positive health benefits. This toxin blocks nervous system signals from reaching the muscles causing them to relax.

Alergan's Botox and Solstice Nuroscience's Myobloc are two of the many available treatments based on the botulinum compounds. These two drugs are medically approved for the treatment of cervical dystonia, which often results in tough or spastic neck muscles. Botox is most widely known for its use in eliminating facial wrinkles.

Public Citizen's review of more than 180 reports provided to the FDA have shown that the Botulism toxin has caused at least 16 deaths and 87 hospitalizations caused by the toxin spreading beyond the site of injection.

You could experience muscle weakness, difficulty in swallowing, or aspiration pneumonia as a side effect from the toxin. Four of the people who died from the injections were children.

Sidney Wolfe, the director of the Public Citizen Health Research Group stated that warning labels due exist on botulin toxin but it is too easy to miss.

The prescribing instructions do state that botulin toxin can spread an paralyze other body parts. Public Citizen says that in order to lower the risk of mortal accidents, the FDA must issue a black box warning in addition to requiring all practicing physicians to provide each patient with a clear, concise guide highlighting this risk prior to 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 says.