Healthy Skepticism Library item: 12567

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Silverman E.
Public Citizen Demands A Black Box For Botox
Pharmalot 2008 Jan 24
http://www.pharmalot.com/2008/01/public-citizen-demands-a-black-box-for-botox/?referer=sphere_related_content

Full text:

The consumer group has filed a petition with the FDA to “immediately increase” warnings to patients and docs about the use of botulinum toxin“ available as Botox and Myobloc“ because of serious adverse reactions, including deaths, linked to the drug. Unlike drug regulatory agencies in Europe, the FDA hasn’t issued any warnings about the toxin, which is used in therapeutic and cosmetic procedures, Public Citizen notes.

The drug is intended to block nerve impulses to certain muscles, causing them to relax. However, in some cases, the toxin has spread to other parts of the body, causing paralysis of respiratory muscles and difficulty swallowing (dysphagia), which can lead to food or liquids entering the respiratory tract and lungs, causing aspiration pneumonia.

A Public Citizen analysis of FDA data found that between Nov. 1, 1997, and Dec. 31, 2006, there were 658 reported cases of people suffering adverse effects from injections of botulinum toxin. Of these, 180 were associated with aspiration (fluid in the lungs), dysphagia and/or pneumonia; 87 required hospitalization. There were 16 deaths, including four in children younger than 18 years old.

The petition also asks the FDA to label the products with a ‘black box’ warning, and require doctors to give patients a medication guide at the time of the injection warning them of possible symptoms of adverse reactions, as well as other information about the drug.

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 says Sid Wolfe, director of Public Citizen’s Health Research Group. Nobody should be dying from injected botulinum toxin.”