Further restrictions placed on Novartis’ treatment for irritable bowel syndrome

4/3/2008

WASHINGTON Novartis has decided to reserve Zelnorm, an irritable bowel syndrome drug, for patients with only an extreme case of the disorder, according to an announcement from the company on Wednesday.

Early reports that there were links to heart attack and strokes made the drug initially available for only a limited-number of patients who where under a special, supervised program by the Food and Drug Administration. Now, the company has placed an even stronger restriction for patients who are only in need of hospitalization, or are experiencing life-threatening symptoms as a result of the disorder.

IBS is an illness that affects the large intestine and causes bloating, abdominal cramping, diarrhea and constipation, and according to published reports, affects about 20 percent of adults in the U.S.

Zelnorm was the only FDA-approved treatment for IBS, which, before its restrictions, made sales of $488 million in the U.S. in 2006, making it the company’s 12th best selling drug.

Now, if any doctors wish to prescribe the treatment they have to get permission from the FDA. Regular sufferers can take heart that there are new drugs in the process of being studied to replace Zelnorm as the drug for IBS, including probiotics, according to reports.

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