Black box warning sought for Botox after 16 deaths

No Big Pharma company likes a black box warning on their drug product, but Public Citizen is asking for just that on Allergan Inc's Botox (botulinum toxin type A), and a similar injection by Solstice Neuroscience Inc. called Myobloc (botulinum toxin type B). Botox is used to de-wrinkle our vain selves and treat cervical dystonia (rigid neck muscles), among other approved uses. Myobloc is approved for cervical dystonia only.

Public Citizen, a national non-profit public citizen organization, reviewed 180 reports of adverse reactions submitted to the Food and Drug Administration by manufacturers, involving muscle weakness, difficulty swallowing or even aspiration pneumonia, a serious condition caused by breathing foreign material into the lungs. Sixteen cases were fatal, four involved children under 18, and some patients were hospitalized.

Director of Public Citizen's Health Research Group stated these complications occur if botulinum toxin spreads from the injection site to the esophagus, resulting in partial paralysis. This complication is included within instructions for both drugs, but Public Citizen is requesting the FDA order a black-box warning of the concern, along with a letter to doctors and a guide to consumers explaining the risks, to be provided by doctors at time of injection. Read their full petition here.

Last year, European regulators cautioned doctors about the dangers of botulinum toxin and posted warnings on its Web site. Public Citizen is basically saying a new, comprehensive system of warnings would raise awareness of potential problems, result in earlier medication intervention and could prevent more serious complications, including death. Makes sense to me.