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Generic Name: alosetron

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A serotoninergic neuroenteric modulator - treats Irritable Bowel Syndrome and Diarrhea

FDA Alerts

Ischemic Colitis and Constipation

Serious adverse GI effects reported, including ischemic colitis and serious complications of constipation, that have resulted in serious injury or death. (See Warnings under Cautions.)
Discontinue immediately and contact clinician if manifestations of constipation or ischemic colitis develop.
Do not resume alosetron in patients who develop ischemic colitis.
Contact clinician if constipation does not resolve after discontinuance of alosetron. If constipation resolves after discontinuance, resume therapy only on advice of clinician.

Restricted Distribution Program

Voluntarily withdrawn from US market by manufacturer in November 2000 because of numerous reports of severe adverse effects, including ischemic colitis, severely obstructed or ruptured bowel, and death; FDA approved a supplemental New Drug Application (sNDA) for alosetron in June 2002, permitting remarketing under restricted conditions of use.
Approved only for severe diarrhea-predominant irritable bowel syndrome (IBS) in women with chronic symptoms who have not responded adequately to conventional therapy. (See Uses.)
May be prescribed only by clinicians who have enrolled in the Prescribing Program for Lotronex^®. Before therapy is initiated, clinician must provide and patient must read the Medication Guide for Lotronex^® and Patient-Physician Agreement for Lotronex^® and both must sign the Agreement. (See Restricted Distribution Program under Dosage and Administration.)

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(a LO ze tron)

What is the most important information I should know about alosetron?

Do not start taking alosetron if you are constipated. If you have constipation while taking alosetron, call your doctor right away.

Serious or fatal side effects on the stomach and intestines have occurred in some people taking alosetron. Alosetron should be prescribed only by a qualified doctor who is enrolled in a prescribing program specific for this drug. You will be required to read and sign a Patient-Physician Agreement form before you get a prescription for alosetron.

In rare cases, alosetron has caused severe constipation, or ischemic colitis (caused by reduced blood flow to the intestines). Stop taking alosetron and call your doctor right away if you develop new or worsening constipation, stomach pain, bloody diarrhea, or blood in your stools (bowel movements). If the constipation is severe or gets worse, and you also have increasing stomach discomfort, stop taking alosetron and do not start taking it again until you talk to your doctor. If your constipation does not improve after you stop taking alosetron, call your doctor again.

Alosetron does not improve the symptoms of IBS for everyone. When alosetron does work well, it helps reduce stomach pain and discomfort, bowel urgency, and diarrhea. Some or all symptoms may improve within one to two weeks of treatment.

What is alosetron?

Alosetron blocks the action of a chemical called serotonin in the intestines. This slows the movement of stools (bowel movements) through the intestines.

Alosetron is used to treat severe, chronic irritable bowel syndrome (IBS) in women who have had diarrhea as the main symptom for at least 6 months. Alosetron should be used only in women who have tried other IBS treatments without success. Alosetron has not been shown to be effective in men with IBS.

Alosetron may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking alosetron?

Do not use alosetron if you have:

constipation (especially if it is your main IBS symptom);
a history of severe or ongoing constipation;
obstruction or perforation of your intestines;
Crohn's disease, ulcerative colitis, or diverticulitis;
blood clots or circulation problems affecting your intestines;
liver disease; or
if you are also taking fluvoxamine (Luvox) to treat obsessive-compulsive disorder.

Tell your doctor if you have ever had any of the conditions listed above.

In rare cases, alosetron has caused severe constipation. Do not start taking alosetron if you are constipated. If you have constipation while taking alosetron, call your doctor right away. If the constipation is severe or gets worse, and you also have increasing stomach discomfort, stop taking alosetron and do not start taking it again until you talk to your doctor. If your constipation does not improve after you stop taking alosetron, call your doctor again. In rare cases, alosetron has caused ischemic colitis, which is caused by reduced blood flow to the intestines. Stop taking alosetron and call your doctor right away if you develop new or worsening abdominal pain, bloody diarrhea, or blood in your stools (bowel movements). FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether alosetron passes into breast milk or if it could harm a nursing baby. Do not take alosetron without telling your doctor if you are breast-feeding a baby. Older adults and those who are ill or debilitated may be more likely to have serious complications from constipation. This medicine should not be given to a child younger than 18 years old.

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