WASHINGTON A health advocacy group has filed a petition with the Food and Drug Administration after discovering that Botox and a similar drug Myobloc have been linked with 16 deaths and a large amount of serious injuries that occurred after the drugs spread to vital organs, according to The New York Times.
The group, Public Citizen, says that the drugs, which are used to relax muscles, should come with a far stronger warning label and patients should be given a letter detailing their risks.
Executives at Allergan, the maker of Botox, issued a statement saying that adverse reactions were rare. And because many patients who get the drug are seriously ill, the company said, it is not proved that Botox caused the reactions. Solstice Neurosciences, who make Myobloc, did not comment on the matter.
Botox is best known for removing wrinkles, but it is also approved to treat knotting of neck muscles, known as cervical dystonia. Doctors can relieve the pain from this for weeks or months when the drug is injected into multiple spots on the neck.
According to Public Citizen, the injection sites can sometimes be so close to the esophagus that it causes partial paralysis and aspiration pneumonia.
The group wants the drug labels to have a prominent section titles “special warnings and precautions for use” and would also like patients to receive a leaflet with warnings about the drugs, like there are on the drugs in Europe.