Serious Gastrointestinal Adverse Reactions

• Infrequent but serious adverse events have been reported with the use of this drug, including ischemic colitis and serious complications of constipation, have resulted in hospitalization, and rarely, blood transfusion, surgery, and death.

Restricted Prescribing Program

• The Prescribing Program for this drug was implemented to help reduce the risks of serious gastrointestinal adverse reactions. Only physicians who have enrolled in the Promethus Prescribing Program for alosetron, based on their understanding of the benefits and risks, should prescribe alosetron [See WARNINGS and Precautions]

Indication

• This drug is indicated only for women with severe diarrhea predominant irritable bowel syndrome refractory to conventional therapy
• Before receiving the initial prescription for this drug, the patient must sign and read the Patient-Physician Agreement.

Discontinuation

• Discontinue immediately upon signs of constipation or symptoms ischemic colitis
• Patients should immediately report constipation or symptoms of ischemic colitis to their physician.
• Alosetron should not be restarted in patients who develop ischemic colitis.
• Patients who have constipation should immediately contact their physician if the constipation does not resolve after alosetron is discontinued.
• Patients with resolved constipation should resume alosetron only on the advice of their treating physician.

Removed from US market in November 2000 and remarketed under restricted dispensing program in June 2002

FDA and Industry Communications

FDA Patient Medication Guide

Patient Counseling Information

• Lotronex

Medication Guides

Patient Medication Guide

Package Inserts

Alosetron