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説明

Lotronex (alosetron) was developed for the treatment of severe irritable bowel syndrome (IBS), and was approved for use by the US Food and Drug Administration (FDA) in 2000. Although Lotronex had a relatively high improvement rate in patients taking the drug for IBS, it was voluntarily pulled from the market by GlaxoWellcome that same year due to reports of severe adverse side effects, some resulting in death.
In 2002, Lotronex was reapproved in a supplemental New Drug Application for use under more restrictive conditions. Now with a risk management program to be consulted prior to administration of the drug, Lotronex is designated to be prescribed only when its medical benefits outweigh the risks of toxic effects; women with severe diarrhea-predominant IBS are now the focal point of prescriptions for Lotronex.