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THE AZAR CORNER
バックナンバー
● For January 2005The
Botox Problem
The Danger Of Using Products Of
Questionable Quality |
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In April 2002 the U.S. Food and Drug Administration (FDA) approved
Botox for cosmetic use. In November 2004 the FDAﾕs office of
criminal investigation and the Florida Department of Health
were investigating whether four people who contracted deadly
botulism were injected with Botox.
The four victims, who remain in serious condition, breathing
with the help of machines, all received the injections at Advanced
Integrated Medical Center in Fort Lauderdale, Florida.
Allergan, the manufacturer of Botox, joined the Center for Disease
Control, the Food and Drug Administration, and the Florida Department
of Health in investigating whether the Botox was contaminated
and, if it was not Botox, what was it and where did it originate?
Within 24 hours of the reported incidence Allergan had determined
that Advanced Medical Center had ordered only two vials of Botox
in 2004. A review of manufacturing and quality assurance processes
involved with the vials determined that no deficiencies or irregularities
were found. Further, a review of all Allerganﾕs safety surveillance
reports revealed that no medical adverse events originated from
the manufacturing lots.
The U.S. media immediately attributed the botulism poisoning
to Botox. However, within 48 hours investigators who had seized
Advanced Integrated Medical Centerﾕs records revealed that an
unapproved wrinkle treatment was thought to be the cause of
the poisoning.
Federal officials have opened a criminal investigation after
seizing documents and computers from an Arizona company, Toxin
Research International (TRI). According to officials, TRI markets
a botulinum toxin product over the Internet and directly to
doctorsﾕ offices.
TRI and its sister company, Powderz, Inc., are headed by Chad
Livdahl and Zahra Karim, two licensed naturopathic physicians,
and markets it botulinum toxin Type A product as ﾒnot for human
useﾓ and ﾒfor research only,ﾓ meaning it could be legally used
only for animal testing. Allergan, however, said doctors have
reported that TRI sends solicitations directly to physicians.
Investigators also are looking into whether the Florida doctor,
who is suspected of injecting the botulinum and is also one
of those hospitalized as a result of the injection, had business
connections with TRI or Powderz. The New York Times reported
that the doctor spoke last year at a seminar sponsored by Powderz.
On the Powderz Web site Livdahl and Karim describe themselves
as chemists who are experts in ﾒcompounding,ﾓ and declare that
compounding is ﾒeasy and profitable,ﾓ encouraging doctors to
train in making their own medications.
The four victims are all paralyzed as a result of botulinum
toxin. They are in critical condition in the hospital and are
only able to move a few fingers and toes. Further investigation
shows that the Advanced Integrated Medical Center failed to
dilute the poison properly in saline solution. The toxin found
in the victims had at least 20,000 units of poison, while properly
prepared Botox has only 100 units per vial.
Botox Eases Breast Surgery Pain
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| ●Botox
Eases Breast Surgery Pain |
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According to the Associated Press, a study by researchers at
the University of Arkansas for Medical Sciences reports that
pain from breast surgery can be reduced by injections of Botox.
According to Dr. Julio Hochberg, professor of surgery in the
plastic surgery division at UAMS and one of the studyﾕs authors,
the injection relaxes chest muscles to diminish the pain and
markedly diminished patientsﾕ need for morphine.
Hochberg reported that the study drew no funding from Allergan,
Inc. and that the company did not know the study was taking
place.
A similar study by Hochbergﾕs group appeared in the Annals of
Surgery in October 2004.
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