Lotronex

U.S. Food and Drug Administration • Center for Drug Evaluation and Research

Drug Information

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Lotronex Information

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

Do Not Buy Lotronex Over the Internet

You should not buy Lotronex over the Internet because you will bypass important safeguards designed to protect your health (and the health of others).
Lotronex has special safety restrictions on how it is distributed to the public. Also, drugs purchased from foreign Internet sources are not the FDA-approved versions of the drugs, and they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities.

To learn more about buying drugs safely, please see

Current Lotronex Information

Current Lotronex Label (6/7/2002)
Approval Letter for Lotronex (6/7/2002)
FDA Press Release on Lotronex (6/7/2002)
Medication Guide for Lotronex (6/7/2002)
Physician Agreement (6/7/2002)
Patient-Physician Agreement. Optional Format: PDF (updated 12/4/2002)
Questions and Answers about Lotronex (6/7/2002)
April 23, 2002 Advisory Committee Meeting. The committee discussed risk management for new drug application (NDA) 21-107, Lotronex (alosetron), GlaxoSmithKline.

Background Lotronex Information

Dear Irritable Bowel Syndrome (IBS) Patient. (1/24/2002)
Letter Regarding Lotronex from Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research (12/18/2000)
FDA Press Release on Withdrawal of Lotronex from the Market. (11/28/00)
Questions and Answers about Lotronex. (11/29/2000)
FDA Press Release on Lotronex. (8/24/2000)

Medication Guide for Lotronex Tablets. (8/24/2000)
Drug Approval Package for Lotronex Tablets. PDF (8/29/2000)
Revised Lotronex Label. Optional format: PDF (8/24/2000)
"Dear Health Care Professional" Letter. Optional format: PDF (8/24/2000)
"Dear Pharmacist" Letter. Optional format: PDF (8/24/2000)
Gastrointestinal Drugs Advisory Committee Meeting (6/27/2000). The topic of this meeting was risk management of post-advertising adverse events associated with Lotronex tablets. Transcripts, briefing information, and questions for discussion are available.
Gastrointestinal Drug Advisory Committee Meeting (11/16/1999). NDA 21-107, Lotronex (alosetron) Tablets.

FDA/Center for Drug Evaluation and Research
Last Updated: December 16, 2002
Originator: OTCOM/DLIS
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