July 27 (Bloomberg) -- Novartis AG said its Zelnorm irritable bowel treatment, pulled from the U.S. market in March, will be made available to some patients at no cost.

The drug will be available through a restricted access program, the Basel, Switzerland-based company said today in a PR Newswire statement. Novartis, Switzerland's largest drugmaker, stopped U.S. sales of the product March 30 at the request of the Food and Drug Administration after people taking the medicine had more heart attacks and strokes.

Zelnorm, which brought in $561 million last year, will be available to women under 55 who suffer from irritable bowel syndrome with constipation, the company said. Sales were stopped after a review of data from 18,000 patients showed that a statistically significant number had heart problems, and one patient died.

``Novartis and the FDA are moving forward with this program because of requests from physicians and patients following the marketing suspension,'' the company said. Doctors will hand out the drug, Novartis said.

Shares of Novartis were unchanged at 64.80 Swiss francs at the close of trading in Zurich. They've dropped 7.8 percent this year.

In March, the Swiss drugmaker said the heart attack rate ``corresponds approximately with the expected rates for such events in the general population.'' About 12 million Americans have the constipation version of the illness, it said.

Tougher Regulators

Zelnorm was approved in 2002 for irritable bowel syndrome and constipation. The FDA asked Novartis to stop sales, and the agency said it would consider a ``limited re-introduction'' if benefits are proven in new tests. Novartis lowered its full-year sales forecasts after the decision.

Regulators are becoming tougher after the recall of Merck & Co.'s Vioxx painkiller because of links to heart attacks and strokes. Last year, the FDA allowed Elan Corp. and Biogen Idec Inc.'s Tysabri multiple sclerosis medicine back on the market after the product was linked to a fatal side effect.

GlaxoSmithKline Plc withdrew the irritable bowel drug Lotronex in 2000 after the medicine was linked to abdominal bleeding and deaths. In 2002, a U.S. government panel backed the medicine's reintroduction, with tight restrictions on access.

To contact the reporter on this story: Christopher Elser in London at celser@bloomberg.net.

Last Updated: July 27, 2007 11:55 EDT