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.
Lotronex (alosetron hydrochloride) is a selective serotonin 5-HT3 receptor antagonist approved for the treatment of women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have chronic IBS symptoms (generally lasting 6 months or longer), have had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and have not responded adequately to conventional therapy. In January 2016, the FDA determined that while safety risks for products containing alosetron hydrochloride (Lotronex and approved generics) still exist, certain restrictive requirements of the risk evaluation and mitigation strategy (REMS) programs are no longer necessary to ensure that the benefits of the drugs outweigh their risks. The Agency will continue to monitor these drugs for safety risks. Major changes to the REMS for these drugs include:
Healthcare professionals who prescribe Lotronex and alosetron hydrochloride:
- Are no longer required to affix prescribing program or REMS program stickers to written prescriptions for Lotronex and alosetron hydrochloride.
- Are no longer required to enroll in the Prescribing Program for Lotronex and the Alosetron REMS Program to prescribe Lotronex and alosetron hydrochloride drugs.
- Healthcare providers who did not previously enroll in the Prescribing Program for Lotronex and/or the Alosetron REMS Program should complete training in the modified REMS programs before prescribing Lotronex and alosetron hydrochloride drugs.
- The modified REMS programs include communications that will inform health care professionals about the changes to the REMS and the safety risks associated with each product.
Patients who take Lotronex or alosetron hydrochloride:
- Are no longer required to complete and sign a Patient Acknowledgment Form. Instead, a Patient Education Sheet is available for the prescriber to discuss with the patient.
Pharmacies that dispense Lotronex and alosetron hydrochloride:
- Pharmacies may dispense Lotronex and alosetron hydrochloride without a prescribing program sticker affixed to a paper prescription.
- Electronic prescriptions for Lotronex and alosetron hydrochloride drugs are now allowed.
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.