Lotronex Back on Shelves for Selected Few

BETHESDA, Md - Officials at the Food and Drug Administration (FDA) have been hesitant to allow selected individuals to receive Lotronex - a pharmaceutica that treats irritable bowel syndrome. The drug has also been linked to the hospitalization of more than 160 patients and the death of seven others.

Irritable bowel syndrome, which afflicts millions in the United States with diarrhea, constipation and abdominal pain, can leave sufferers confined to their homes or wearing diapers. Eleven percent of the American public is estimated to be suffering from the syndrome, with the majority of those patients being women.

A panel decided to allow certain patients access to the drug after listening to advocates on both sides of the argument. For additional information about the Lotronex Action Group and this issue, see the Fall, 2001 issue of EndoNurse magazine. http://www.endonurse.com/articles/191pharma.html).

The FDA is working with the drug manufacturer, GlaxoSmithKline, to ensure the drug's use is monitored. The plan to date includes allowing only physicians who treat irritable bowel syndrome to prescribe Lotronex. In addition, recipients will have to sign a consent form and get 30-day supplies at a time. They must follow up with a doctor's visit to receive an additional month's supply. The recommended dose has been decreased by 50 percent and if the patient notices any side effects, he or she is to report immediately to the hospital.

The patients will be registered in a national database and tracked as well.

Why such a fuss? The FDA has 238 reports of severe side effects reportedly caused by the drug including life-threatening intestinal inflammation and potentially lethal constipation. Of these reported incidences, 163 were hospitalized and 51 needed surgery.

Other studies have shown the drug provides relief for female patients, although it has not shown to work for men. Those who have the most severe cases of IBS seemed to receive the most benefit from the drug - some 5-10 percent of all cases.

Information from www.msn.com.

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