Lotronex (alosetron hydrochloride) Information
FDA announced on 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.
Note: Prometheus acquired the NDA for LOTRONEX from GlaxoSmithKline (GSK) in January 2008.
Do Not Buy Lotronex Over the Internet
To learn more about buying drugs safely, please see Buying Prescription Medicines Online: A Consumer Safety Guide.
Adverse reactions or quality problems experienced with the use of this drug may be reported to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this page.
Lotronex (alosetron hydrochloride) Tablets Prescribing Information and Medication Guide Apr 2008
- Lotronex (alosetron hydrochloride) - Medication Guide (2008)
(includes the Patient-Physician Agreement and the Prescribing Program)
Lotronex Regulatory History and Labeling from Drugs@FDA Buying Prescription Medicine Online: A Consumer Safety Guide
Questions and Answers about Lotronex (6/7/2002)[ARCHIVED] April 23, 2002 Joint Meeting with the Risk Management Subcommittee of the Advisory Committee for Pharmaceutical Science The committee discussed risk management for new drug application (NDA) 21-107, Lotronex (alosetron), GlaxoSmithKline. 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) Questions and Answers about Lotronex (11/29/2000)[ARCHIVED] Lotronex- "Dear Health Care Professional" Letter (8/24/2000) pdf(PDF - 15KB) Lotronex - "Dear Pharmacist" Letter (8/24/2000) pdf(PDF - 16KB) Gastrointestinal Drugs Advisory Committee Meeting
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.