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Lotronex is a drug intended to treat women with irritable
bowel syndrome. In the drug's first eight months on
the market, five people who took it died. Several others
underwent bowel surgeries -- one had a colon removed.
A total of 49 patients developed ischemic colitis, a
potentially life-threatening complication.
Lotronex began arriving on pharmacy shelves in March.
In April 2000, the FDA received the first voluntarily
filed reports of serious side effects among the new
patients. By early June, a total of eight new ischemic
colitis cases had emerged. Six other Lotronex patients
were hospitalized with constipation-related complications,
and three of them required surgery. The first fatality
of a Lotronex patient was reported to the FDA on July
17, a 50-year-old woman who suffered "mesenteric
occlusion," a severe blockage of blood to the colon.
This report, filed voluntarily by a health professional,
identified Lotronex as the "primary suspect"
drug in the death.
On Aug. 24, the FDA and Lotronex's manufacturer announced
a safety labeling change. Records kept by the FDA show
that through Oct. 30, the agency had received 93 reports
of patients being hospitalized after taking Lotronex.
In each of the reports, the doctor or other party cited
Lotronex as the "primary suspect" drug in
the event.
If you or a family member have taken the drug Lotronex
and have suffered side effects or developed ischemic
colitis, call attorney Paul Wilkins at 1-877-569-8378
to discuss your legal rights and learn more about our
investigation.
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