Warnings over botox after 16 deaths

By Staff Writer, PinkNews.co.uk • January 28, 2008 - 10:10

Public Citizen has reviewed 180 reports submitted to the US Food and Drug Administration.

No Comments Yet on Warnings over botox after 16 deaths

If you are one of the millions of people who has used Botox to help eliminate signs of aging, new reports my cause you to raise an eyebrow.

The US Consumer group Public Citizen is calling for harsher warnings to be added to labels after 16 deaths related to the spread of botulinum toxin have been reported.

Botox, created by Allergan Inc, is a is a form of injected poison primarily used to smooth out wrinkles in the face and neck.

Allergen projected over a billion dollars in sales of the drug in 2007.

According to Reuters, Public Citizen has reviewed 180 reports submitted to the US Food and Drug Administration by manufacturers involving patients injected with Botox or Myobloc, a similar muscle inhibitor.

The reports detailed cases of muscle weakness, difficulty swallowing and aspiration pneumonia, a serious condition caused by breathing a foreign material into the lungs.

Sixteen cases reported to the FDA were fatal, including four involving children under 18, while 87 patients were hospitalised, according to Public Citizen's findings.

Because of the deaths, the group is asking the FDA to put so-called "black box warnings" on Botox products so consumers will be aware of the possibility of dangerous side effects.

Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group, explained to Reuters:

"Nobody should be dying of Botox, and they wouldn't be dying if the government and companies were doing a better job."

Symptoms indicating a serious reaction to the substance include dry mouth, difficulty breathing or swallowing, slurred speech, drooping eyelids and muscle weakness.

In a press release, Dr. Foad Nahai, MD, president of the American Society for Aesthetic Plastic Surgery stated:

"We believe that the safety references in the petition are already satisfactorily addressed in the manufacturer labeling with detailed information and guidance, including approved indications, contraindications, warnings, drug interactions, precautions, and reported adverse event information.

"We believe that the product is safe and efficacious, and we recommend its continued use as indicated."

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