Lotronex (alosetron) is the only medication that is FDA approved to treat diarrhea-predominant IBS (IBS-D). Although many people experienced significant symptomatic relief from Lotronex, serious side effects (including fatalities) resulted in the medication being taken off of the market in 2000. In part because of patient demand, the medication was made available again in 2002, but with strict guidelines regarding the circumstances under which Lotronex can be prescribed.
According to the FDA, Lotronex should only be prescribed for patients for which the following is true:
- "The main IBS problem is diarrhea
- IBS has gone on for a long time, 6 months or longer
- A physician has informed the patient that symptoms are not due to other medical problems
- Other IBS treatments have been tried and none has helped"
The FDA will only approve Lotronex if the patient's IBS symptoms are severe. The FDA describes IBS-D as severe if the following symptoms are present:
- "Lots of painful stomach cramps or bloating
- Inability to control the need to have a bowel movement or have "accidents" where underwear gets dirty from diarrhea or bowel movement (stools)
- Inability to lead a normal home or work life because of the need to be near a bathroom"
Lotronex is thought to prevent serotonin, a neurotransmitter, from acting on specific receptor sites within the gut known as 5-HT3 receptors. This action results in a slowing of intestinal contractions, thus reducing diarrhea and urgency.
There is strong research support for the effectiveness of Lotronex in normalizing stool frequency and appearance, as well as relieving the following symptoms:
- abdominal pain and discomfort
- urgency
- overall IBS symptoms
Although Lotronex is only approved for treatment of women with IBS-D, research has shown that Lotronex is effective in relieving pain and discomfort, but not other IBS symptoms, in males.
The most commonly reported side effect of Lotronex is constipation, and this effect appears to be related to dosage size. A rare, but dangerous side effect, is ischemic colitis, an inflammation of a part of the intestines related to a reduction of blood flow. If you are taking Lotronex, you should call the doctor if you experience:
- constipation
- increasing abdominal pain
- any sign of blood in your stools
American College of Gastroenterology IBS Task Force An Evidence-Based Position Statement on the Management of Irritable Bowel Syndrome American Journal of Gastroenterology 2009:S1-S35.
Federal Drug Administration. "Questions and Answers about Lotronex Accessed October 2009.
Gaman, A., Bucur, M. & Kuo, B. Therapeutic advances in functional gastrointestinal disease: irritable bowel syndrome Therapeutic Advances in Gastroenterology 2009 2:169-181.
Of Note: The manufacturers of Lotronex are offering financial assistance for Lotronex users: Co-Pay Assistance for Lotronex
