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Science Forum Index » Medicine - Nursing Forum » NYTIMES: Group Seeks New Warning About Botox ... 16 deaths
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| Ilena Rose |
 Posted: Sat Feb 16, 2008 2:03 pm |
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Guest
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Note from Ilena Rosenthal: Interesting that the Health Frauds go
ballistic and Sue Happy over safe homeopathy ... yet nary a word on
the dangers of breast implants or botox.
www.BreastImplantAwareness.org/QuackWatchWAtch.htm
Health Lover
http://ilenarose.blogspot.com
http://www.nytimes.com/2008/01/25/health/policy/25botox.html?_r=1&ref=us&oref=slogin
Group Seeks New Warning About Botox
By GARDINER HARRIS
Published: January 25, 2008
WASHINGTON — Botox and a similar injected drug have been associated
with 16 deaths, four of them in children, and scores of serious
injuries that occurred after the drug spread to vital organs, a health
advocacy group says.
The drug, a neurotoxin that is used to relax muscles, should come with
a far stronger warning label and patients should be given a letter
detailing its risks, the group, Public Citizen, said in a petition
filed Thursday with the Food and Drug Administration.
Julie Zawisza, a spokeswoman for the agency, said she could not
comment while the petition was under review.
Executives at Allergan, the maker of Botox, issued a statement saying
that adverse reactions were rare. And because many patients who get
the drug are seriously ill, the company said, it is not proved that
Botox caused the reactions. Solstice Neurosciences, the maker of a
similar drug, Myobloc, did not return a message for comment.
Perhaps best known as a wrinkle remover, Botox is also approved to
treat cervical dystonia, a painful knotting of neck muscles. Doctors
inject it into multiple spots on the neck, relieving sometimes
disabling pain for weeks or months.
But the injection sites sometimes come perilously close to the
esophagus, causing partial paralysis that can lead patients to have
difficulty swallowing and suffer aspiration pneumonia, caused by
breathing in food or liquids, Public Citizen said.
Of the 16 people who died, only one is known to have been undergoing a
cosmetic treatment for wrinkles. Most of the others suffered muscle
problems or their condition was unknown.
The deaths might have been prevented had patients been adequately
warned of the possible dangers, said Dr. Sidney M. Wolfe, director of
Public Citizen’s health research group. The labels for Botox and
Myobloc mention the issue but not prominently enough, Dr. Wolfe said.
“Nobody should die from the medical use of Botox,” Dr. Wolfe said.
“The fact that they are shows that patients don’t have a clue about
these problems.”
Health authorities in Europe have done a far better job of
highlighting the drugs’ dangers, Dr. Wolfe said. The authorities in
Britain and Germany have required drug manufacturers to send letters
to doctors warning of the dangers.
On Aug. 9, the Danish Medicines Agency published an analysis of
adverse events associated with the products. The analysis found 600
problems associated with the drugs, the petition stated. Half of the
serious problems associated with the drugs occurred after the toxin
spread, the petition said.
The drugs’ labels in Europe have a prominent section titled “special
warnings and precautions for use” that warns of the dangers of the
spread of the toxin. The Danish authorities also warned that muscle
weakness associated with Botox may be long-lasting, especially among
children, the elderly and those suffering serious neurological
problems.
Patients in Europe also receive a leaflet warning them to seek medical
help if they have trouble breathing, experience dry mouth or have
trouble swallowing.
The drugs’ manufacturers and others have reported to the F.D.A. 658
cases of problems associated with Botox and Myobloc, Public Citizen
said. |
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