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FDA Warns of Connection Between Botox and Botulism-Related Deaths

The Federal Drug Administration wants people to know that the anti-wrinkle drug Botox has been linked to several botulism related-deaths. A number of these victims were children. The warning comes three weeks after
Public Citizen, a consumer advocacy group, cited 180 reported incidents-including 16 deaths-where people who had used Botox experienced pneumonia, difficulty swallowing, or fluid in the lungs. Botox Cosmetics and its competitor Myobloc were named in last week’s FDA warning.

Botox causes nerves to relax because the botulinum toxin injected into a specific area of the body blocks nerve impulses. Sometimes, however, the toxin can spread to other areas of the body, which can weaken or paralyze the muscles needed to breathe or swallow. This can be fatal.

The children who died after using Botox were given the drug to treat spasticity problems in their legs. The FDA is also looking at other reported incidents involving adults that used Botox. One woman who used Botox to hide her forehead wrinkles reportedly had to be hospitalized.

Many adults use Botox injections on their faces to minimize the presence of wrinkles. Botox is also used to treat a number of spasm conditions, such as severe neck spasms or cervical dystonia.

Although Botox labels include a warning about possible botulism toxin and how this can lead to death, the labels only link these potential side effects to people with neuromuscular illnesses.

The FDA is warning Botox users to seek medical attention immediately if they experience any botulism symptoms, including:

• Slurred speech • Problems swallowing • Problems breathing • Problems holding up one’s head • Muscle weakness
FDA: Botox linked to kids’ deaths, MSNBC/AP, February 8, 2008

Related Web Resources:

Group seeks Botox warning following 16 deaths, MSNBC/Reuters, January 24, 2008
Botox, FDA
Drug manufacturers are supposed to provide proper warning of any and all potential side effects from taking a drug. When failure to provide sufficient warning results in injury or death, the drug maker can be held liable in a products liability or wrongful death lawsuit. One of our Massachusetts defective products lawyers would be happy to speak with you about your case.

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