A health advocacy group, Public Citizen, filed a petition with the Food and Drug Administration on January 24, 2008 seeking stronger warning labels for Botox and asking that patients also receive risk assessment materials prior to treatment.

According to the group, Botox, a neurotoxin best known for its use for cosmetic purposes, caused 16 deaths including four in children when the substance spread to vital organs after injection. The exact number of non-fatal but serious injuries is not known.

The action by Public Citizen does not specifically target the cosmetic use of Botox. Because the neurotoxin causes temporary paralysis, it is a popular remedy for frown lines and wrinkles. However, Botox is also used to treat dystonia or knotting of the neck muscles. Injection in this region of the body places the neurotoxin in close proximity to the esophagus.

According to the assertions made by Public Citizen, partial paralysis can result, leading to difficulty in swallowing and elevating the patient’s chances of contracting aspiration pneumonia. In a statement issued by Allergan, the company that makes Botox, adverse reactions were characterized as rare. Those individuals receiving Botox for non-cosmetic purposes are often quite ill to begin with, said the statement, and thus it is not possible to conclusively prove that Botox caused adverse reactions or a worsening of their symptoms.