Novartis further curbs Zelnorm use in U.S. -FDA

WASHINGTON, April 2 (Reuters) - Novartis (NOVN.VX)(NVS.N) is abandoning an earlier plan to provide its bowel drug Zelnorm to U.S. patients on a restricted basis, health regulators said on Wednesday.

The Swiss drugmaker last year made a deal with the U.S. Food and Drug Administration to provide the drug for a limited number of patients with irritable bowel syndrome after the agency called for it to be pulled from the market over concerns about a possible link to heart attacks and strokes.

But the FDA said Novartis would now make Zelnorm available only to patients whose condition is life-threatening or who are so sick they require hospitalization. The decision to curb the use was a voluntary one by the drugmaker and not a move by the agency, it added.

Doctors who want the drug for their patients will have to ask the FDA for permission to authorize any shipment from the company.

"FDA may deny authorization, even in life-threatening situations, if available evidence fails to provide a reasonable basis for concluding that Zelnorm may be effective for the intended use, or if exposure to Zelnorm would pose an unreasonable or a significant additional risk to patients," the agency said in a notice on its Web site.

The agency said it may deny the drug to those who have a history of heart problems, diabetes, obesity, depression or are older than 55, among other criteria.

Novartis pulled Zelnorm from U.S. shelves in early 2007 after clinical trial data suggested a possible heart risk. In July 2007, it began offering the drug under a special program at no cost to treat irritable bowel syndrome in some women younger than 55 who also experienced constipation.

A spokeswoman for Novartis did not immediately return a call seeking comment.

Zelnorm is the only FDA-approved drug to treat patients with irritable bowel syndrome whose main symptom is constipation. Other drugs can help treat symptoms, the FDA said.

(Reporting by Susan Heavey, editing by Dave Zimmerman)