Lotronex
(Alosetron)
What
is Lotronex?
Lotronex,
also known as Alosrtron, was a drug prescribed to treat
Irritable Bowel Syndrome (IBS).
Lotronex was manufactured by Glaxo Wellcome and introduced
onto the market February 28th, 2000.
The FDA only approved Lotronex for treatment of
women with IBS whose primary symptom was diarrhea.
What is IBS?
Irritable
Bowel Syndrome (IBS), is not a disease or virus, rather
it is a disorder. Scientists
do not know what causes every case of IBS, but much may
be related to food allergies. Women who suffer from IBS may experience
symptoms consisting of abdominal discomfort, sudden urgency
to have a bowel movement, constipation and diarrhea.
Lotronex was only approved to treat those women with
diarrhea as their primary symptom.
It is estimated that IBS effects about 15-20% of
the US population (about 52 million) with 75% of that number
being women.
Why was Lotronex recalled?
On
November 28, 2000, the FDA called for the removal of Lotronex
from the market. This
came after 93 patients taking Lotronex had been hospitalized,
49 reported incidents of ischemic colitis and 5 deaths.
Clinical trials showed that 27% of those who took
Lotronex became so severely constipated that they had to
drop out of the trials.
By
August of 2000, the FDA saw that patients were not receiving
a proper warning and called on Glaxo Wellcome to put a black
box label on the package. Glaxo fought this measure and issued pamphlets
instead. Unfortunately
these pamphlets did not reach patients until October of
2000.
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