Lotronex Drug Recall
Irritable Bowel Syndrome (IBS)
Glaxo Wellcome, Inc. pulled Lotronex off the the market on
November 28, 2000. Lotronex is a popular prescription drug treatment
for women's irritable bowel syndrome. The U.S.
Food and Drug Administration has 124 reports of Lotronex patients
experiencing hospitalizations, disabilities, or urgent medical treatments,
including 8 women who have died with intestinal side effects. So
far, the FDA has classified a total of 70 of the reports as probably
caused by Lotronex. The drug is reported to cause severe side
effects, including a life-threatening intestinal inflammation called
ischemic colitis, and constipation so severe that some patients require
removal of parts of their intestines.
Lotronex received FDA approval in February after receiving
priority-review status because there was no approved treatment for
irritable bowel syndrome. The affliction affects about 15% of the
U.S. population and is two to three times more common in women than in
men. Irritable bowel syndrome is characterized by chronic or
re-current abdominal pain and irregular bowel movements. Since
approval, Lotronex has been reportedly been used by about 150,000 people.
Earlier this year, the FDA required that Glaxo Wellcome issue an
agency-reviewed medication guide to be distributed in connection with the
sale of Lotronex. The medication guide warned patients who become
constipated or experience worsening abdominal pain while taking Lotronex
to stop taking the drug and contact a physician immediately.
Consumer groups say that Lotronex is neither safe nor effective in
treating irritable bowel syndrome, and that risks of taking Lotronex
clearly outweigh any medical benefits.
If you or someone you know is suffering or is experiencing any health
issues as a result of taking the Lotronex drug please contact us
immediately.
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