LOTRONEX

LOTRONEX

What is Lotronex?

Lotronex, also known as alosetron, is used to treat diarrhea, pain, and cramps caused by irritable bowel syndrome (IBS; a condition that causes stomach pain, bloating, constipation and diarrhea). It works by slowing the movement of stool through the intestines.

Side Effects:

Side effects of Lotronex include upset stomach and hemorrhoids. In addition, the more serious symptoms of ischemic colitis include rectal bleeding, bloody diarrhea and new or worsening abdominal pain. Lotronex should be discontinued immediately in patients who develop constipation, blood in the bowel movements, or new or worse pain in the abdominal or stomach area.

Dangers of Lotronex:

Lotronex has been associated with reports of serious intestinal conditions, including ischemic colitis and constipation, some so severe that those patients needed to have part of their intestines surgically removed. These conditions have lead to hospitalization, blood transfusions, surgery, and even death.

FDA Concerns:

The FDA investigated the reports of dozens of cases of ischemic colitis and severe constipation. The FDA ordered Glaxo to attach special safety warnings to every bottle, urging doctors not to prescribe it to patients with constipation or other risk factors, and telling women to stop using it at the first sign of trouble.

Lotronex was voluntarily withdrawn from the market by the manufacturer on November 28, 2000, after discussions with FDA concerning the severity and number of adverse reactions resulting from the use of the medication.

The FDA announced June 7, 2002 the approval of a supplemental New Drug Application (sNDA) that allows restricted marketing of Lotronex, to treat only women with severe diarrhea-predominant irritable bowel syndrome. It includes a risk management program to ensure patients and physicians are fully informed of risks and possible benefits of Lotronex.

Jim Keller
Partner at Keller & Keller

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