UPDATE 4-Novartis pulls Zelnorm in U.S., cuts 2007 outlook

(Recasts; adds FDA comments, background, closing share price)

By Thomas Atkins

ZURICH, March 30 (Reuters) - Novartis (NOVN.VX: Quote, Profile, Research, Stock Buzz) pulled bowel drug Zelnorm from U.S. shelves on Friday at the request of regulators because clinical trial data indicated a possible link to heart attacks and strokes.

The move is a body blow to the drug, a treatment for irritable bowel syndrome which previously had run into safety issues and never been approved for use in Europe, and it prompted Novartis to cut its 2007 sales forecast.

The Swiss drugmaker said the U.S. Food and Drug Administration had asked it to suspend marketing and sales to permit further discussion of benefits and risks of the medicine.

FDA officials said Zelnorm might be able to return on a limited basis but only if a group of patients could be identified for whom the benefits outweighed the risks.

Zelnorm was Novartis's 12th-biggest selling drug in 2006, with global turnover growing 30 percent to $561 million, of which $488 million was generated in the United States.

About 500,000 U.S. patients are taking Zelnorm, Novartis spokeswoman Anna Frable said.

Novartis shares (NVS.N: Quote, Profile, Research, Stock Buzz) fell $2.26, or nearly 4 percent, to close at $54.63 on the New York Stock Exchange.