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Alosetron hydrochloride (Lotronex) for irritable bowel syndrome

Michael Camilleri, MD
Section Editor
Nicholas J Talley, MD, PhD
Deputy Editor
Shilpa Grover, MD, MPH, AGAF


Alosetron hydrochloride is a selective 5-HT3 antagonist that has been approved for the treatment of women with severe diarrhea-predominant irritable bowel syndrome (IBS) who failed to respond to conventional treatment. The drug has been reintroduced to the market after being withdrawn due to adverse effects including severe constipation and ischemic colitis. Communications from the US Food and Drug Administration (FDA) suggest that fewer than 5 percent of patients with IBS are considered to have severe disease, have symptoms that last more than six months and curtail daily activities, and that only a fraction of these have diarrhea-predominant symptoms. Thus, the proportion of IBS patients who will be eligible for alosetron is small.

Physicians who wish to prescribe alosetron are required to:

Self-attest to their qualifications

Agree to educate patients on the risks and benefits of treatment and provide patients a copy of the FDA-approved medication guide

Obtain a written agreement from patients before their initial prescription

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Literature review current through: Nov 2017. | This topic last updated: Sep 06, 2017.
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