Lotronex®

The manufacturer of Lotronex® (alosetron) tablets -- a drug used to treat irritable bowel syndrome in women -- voluntarily decided to withdraw Lotronex® from the market after discussions with the Food and Drug Administration (FDA) on how to best manage risk.

This drug was associated with reports of serious side effects such as intestinal damage as a result of reduced blood flow to the intestine (ischemic colitis), severely obstructed or ruptured bowels (complications of severe constipation), and death.

Recently, FDA and GlaxoSmithKline(GSK) announced FDA's decision to approve GSK's application to make the prescription drug Lotronex® (alosetron) available again in the near future. Because of serious safety concerns, Lotronex® will only be available through a restricted marketing program. Lotronex® is only approved for women with severe diarrhea-predominant irritable bowel syndrome (d-IBS) who meet certain criteria. It is estimated that only 5% of IBS patients have severe IBS, and fewer have severe diarrhea-predominant IBS.

Source: fda.gov

If you or a loved one has been harmed by Lotronex®, you may want to contact a Lotronex® attorney for more information.