Lotronex Recall Information
Lotronex is manufactured by Glaxo Wellcome,
Inc. and was prescribed for irritable bowel syndrome (IBS). IBS, a disorder
that affects mostly women, involves chronic or recurrent abdominal pain,
the sudden need to go to the bathroom, and either frequent diarrhea, constipation,
or both.
Glaxo Wellcome recalled Lotronex from the
market on November 28, 2000 after it was linked to a number of deaths.
It had only been on the marked for approximately nine months.
The Food and Drug Administraiton (FDA) has reviewed a
total of 70 cases of serious adverse events, including 49 cases of ischemic
colitis and 21 cases of severe constipation. Of these cases, 34 resulted
in hospitalization without surgery, ten resulted in surgical procedures,
and three resulted in death.
On November 28, 2000, the FDA announced that it had asked
Glaxo Wellcome to withdraw Lotronex from the market. The FDA
is advising patients taking Lotronex to contact their health care providers
to discuss treatment alternatives for Irritable Bowel Syndrome.
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