FDA Approves Lotronex for IBS in Women
Dateline 2/10/00
The FDA has granted approval to Glaxo Welcome to market Lotronex (alosetron) for women diagnosed with IBS whose primary symptom is diarrhea. This new drug should help the millions of women who suffer from irritable bowel syndrome (IBS) find relief from this painful condition. IBS affects an estimated 1 in 5 adult Americans with three times as many women as men suffering from this chronic medical condition.
Irritable bowel syndrome is the most common diagnosis among gastroenterology practices in the US and is one of the top ten most frequently diagnosed conditions by physicians. However, millions suffer in silence with less than half of those who experience symptoms ever seeking medical treatment.
IBS is a functional disease, it does not show up in x-rays, MRIs, or other tests (diagnosis should include diagnostic testing to rule out other causes). Irritable bowel syndrome makes its presence known through its symptoms which include persistent and recurrent abdominal pain and discomfort, a sudden and urgent need to go to the bathroom, and diarrhea and/or constipation.
Other symptoms include abdominal bloating, the passage of mucous with the bowel movement, and a feeling of inability to empty completely. Strong and painful spasms also often occur. Patients often experience symptoms after eating, about half of patients report eating certain foods makes their symptoms worse, which subside after a bowel movement.
Various other terms have been used to describe IBS including colitis, mocous colitis, spastic colon, spastic bowel, and functional bowel disease. For the most part, these terms are an inaccurate description. An example is the term colitis which means an inflammation of the colon (large intestine), IBS does not cause inflammation and should not be misinterpreted as the much more serious condition ulcerative colitis, or as Chron's disease. IBS should also not be confused with diverticultis which is an inflammation of the colon's diverticula (small pouches).
The cause of IBS is still unknown, although it is known that it does not have an organic origin. Some thought is given that stress may be a contributing factor, but stress is not a lone cause of irritable bowel syndrome. Studies have found that the colon of those with IBS begins to spasm after only mild stimulation, people with IBS seem to have colons that are more sensitive than normal so that it responds sometimes violently to stimulation that would not bother most people.
Triggers can include eating certain foods, taking certain medications, and bloating from gas. Some of the most common offenders include chocolate, milk and milk products, and alcohol, as well as caffeine. Women with IBS have been found to experience more symptoms during menstruation suggesting that hormones may play a role in increasing IBS symptoms.
Fortunately, IBS has not been linked to any serious diseases; there is no known link between IBS and inflammatory bowel diseases; and IBS does not lead to cancer.
Lotronex is only one of several drugs currently available to help relieve the symptoms of irritable bowel syndrome. The FDA cautions that Lotronex is not a cure, but a treatment that offers modest relief from pain and diarrhea associated with IBS. Lotronex is only for women for whom diarrhea is a primary symptom. The drug has not been found effective in men or in women whose primary symptom is constipation.
Glaxo Wellcome expects Lotronex to be available to patients by prescription in mid-March. Patients will take 2 one milligram tablets a day at a cost of about $1.98 per tablet.
More About Irritable Bowel Syndrome
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