The FDA ( Food and Drug Administration ) announced that it is permitting the restricted use of Zelnorm ( Tegaserod ) under a treatment investigational new drug ( IND ) protocol to treat irritable bowel syndrome with constipation ( IBS-C ) and chronic idiopathic constipation ( CIC ) in women younger than 55 who meet specific guidelines.

In addition to the age and gender restrictions, the IND protocol for Zelnorm limits use of the drug to those with irritable bowel syndrome with constipation or chronic idiopathic constipation whose physicians decide the drug is medically necessary. Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of Zelnorm.

On March 30, 2007, the FDA asked Novartis, the manufacturer of Zelnorm, to suspend its U.S. marketing and sales because a safety analysis found a higher chance of myocardial infarction, stroke, and unstable angina in patients treated with Zelnorm compared with treatment with an inactive substance ( placebo ).

At that time, the FDA indicated that there might be patients for whom the benefits of Zelnorm treatment outweigh the risks and for whom no other treatment options were available. FDA committed to work with Novartis to allow access to Zelnorm for those patients through a special program. That work yielded this IND protocol.

Irritable bowel syndrome is a disorder characterized most commonly by cramping, abdominal pain, bloating, constipation, and diarrhea. IBS causes a great deal of discomfort and distress, but it does not permanently harm the intestines and does not lead to disease. For some people, however, IBS can be disabling. They may be unable to work, attend social events, or even travel short distances.

Patients are considered to have chronic constipation if they have fewer than three complete spontaneous bowel movements per week and at least one of the following symptoms for at least 25 percent of those bowel movements: straining, hard stools, incomplete evacuation.

Source: FDA, 2007

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