Lotronex (alosetron) is a drug for the treatment of irritable bowel syndrome with diarrhea (IBS-D). It blocks serotonin signals that transmit sensory information (painful and non-painful) from the gut to the brain and helps to reduce diarrhea and belly pain. Alosetron has been approved for the use in women with severe diarrhea-predominant IBS. It is only prescribed under restricted use due to rare but potentially serious side effects. Use includes a Risk Management plan to help reduce potential serious outcomes of an adverse event.
FDA Approves Restricted Marketing of Lotronex
(June 7, 2002) The Food and Drug Administration (FDA) today announced the approval of a supplemental New Drug Application (sNDA) that permits marketing of Lotronex (alosetron hydrochloride) with restrictions through an established Prescribing Program for Lotronex™ (PPL). Lotronex may be prescribed only by physicians who have enrolled in the PPL. The drug's indication has been narrowed to be only for treatment of women with severe, diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed to respond to conventional IBS therapy. Limiting the use of Lotronex to this severely affected population is intended to maximize the benefit to risk ratio.
You MUST do 3 things if you are going to take LOTRONEX (From FDA Medication Guide):
1) Understand that LOTRONEX has serious risks.
2) Sign a Patient-Physician Agreement with your doctor.
3) Follow the directions in this Medication Guide.
If you can't do ALL of these, you should not take LOTRONEX.
Read this Medication Guide carefully before you sign the Patient-Physician Agreement and before you start to take LOTRONEX. Read the Medication Guide you get with each refill for LOTRONEX. There may be new information. This Medication Guide does not take the place of talking with your doctor.
What is the most important information I should know about LOTRONEX? Because of serious bowel side effects, including some deaths, seen with use of this drug, LOTRONEX is only for women who have very bad irritable bowel syndrome and whose main problem is diarrhea (diarrhea-predominant IBS). To decide if you want to use LOTRONEX, you need to know about possible side effects of LOTRONEX and how LOTRONEX may help your IBS. Very few patients have diarrhea-predominant IBS that is bad enough to consider using LOTRONEX.
Product information and prescribing information for physicians, pharmacists, and patients may be found at this Prometheus Lotronex web site.
What are Phases?
Treatment trials or studies are in phases:
- Phase 1 tests a new drug or treatment in a small group to evaluate its safety, determine a safe dosage range, and identify side effects;
- Phase 2 expands the study to a larger group of people to see if it is effective and to further evaluate its safety;
- Phase 3 expands the study to an even larger group of people to confirm its effectiveness, monitor side effects, and collect information that will allow the drug or treatment to be used safely.