Alosetron Hydrochloride Oral tablet

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• Voluntarily withdrawn from US market by manufacturer in November 2000 because of numerous reports of severe adverse effects, including ischemic colitis, severely obstructed or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.)

REMS:

FDA approved a REMS for alosetron to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of alosetron and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).