Public Citizen, the national, nonprofit consumer advocacy organization, recently petitioned the Food and Drug Administration (FDA) to immediately increase warnings and to directly warn patients and doctors about the use of botulinum toxins used cosmetically to reduce wrinkles and therapeutically for other purposes. The most common forms, Botox and Myobloc, have been linked to 16 deaths (four in children under 18) and 180 cases of people developing sometimes life threatening conditions.

Group analyzes FDA data

Public Citizen researchers analyzed FDA data which it said came from voluntary reports that are estimated to account for only 10 percent of actual cases. According to a press release from the group:

The FDA has approved the use of botulinum toxin for a limited number of ‘therapeutic’ conditions, including uncontrollable neck and shoulder muscle contractions, crossed eyes, spasmodic blinking of the eyes and excessive underarm sweating. The only approved cosmetic use is for temporary smoothing of wrinkles between the eyebrows. Most cosmetic uses of botulinum toxin are unapproved. (Emphasis added)

It analyzed date from November of 1997 through December 2006 and found that there were 658 reported cases of people suffering adverse effects from injections of botulinum toxin. Of those, 180 cases were associated with aspiration (fluid in the lungs), dysphagia (difficulty swallowing) and/or pneumonia and 87 cases required hospitalization.

It clarified that cases of dysphagia were common in pre-approval studies for therapeutic uses and that, although most cases were mild, severe cases did occur, even with the limited number of people exposed in these studies.

Group says FDA should follow European lead

Public Citizen encouraged the FDA to follow the lead of the European Union (EU) who addressed the problem in 2007. It stated that the EU took steps last year to caution doctors about the dangers of botulinum toxins by posting warnings on its website. In addition, other countries, such as the United Kingdom and Germany, have sent letters to doctors regarding the possible health risks.

Symptoms

Public Citizen stated that early symptoms may include:

• Dry mouth
• Difficulty swallowing
• Difficulty breathing
• Slurred speech,
• Drooping eyelids
• Muscle weakness

The group has stated that the FDA has not required the issuance of direct warnings to either doctors or patients so far. To view Public Citizen’s press release, go to: http://www.citizen.org/pressroom/release.cfm?ID=2593.