Novartis Yanks Zelnorm

The Food and Drug Administration said Friday that Zelnorm, the Novartis(NVS Quote) treatment for irritable bowel syndrome, is being taken off the market because it can increase the risk of heart attacks, stroke and chest pain associated with heart disease.

Novartis agreed to pull the drug when the FDA made its request on March 29, one day after the agency met with the company to discuss Zelnorm's safety issues, said Dr. John Jenkins, director of the FDA's office of new drugs.

Despite agreeing to the FDA's request, Dr. Daniel Vasella, the chairman and CEO of Novartis, said there was no reason to withdraw the drug because there was "no causal relationship" between Zelnorm and heart problems.

"We have not proven causality," said Jenkins in a telephone press conference. However, "the data are very concerning."

Jenkins said the agency acted after reviewing a new safety analysis of Zelnorm, which was based on the pooling of data from 29 clinical trials involving more than 18,000 patients. The research showed a higher heart-damage risk for patients who received Zelnorm than those getting a placebo.

Vasella said his company will work with the FDA to determine if the drug could be resurrected to treat some patients. "We believe Zelnorm provides benefits for appropriate patients," Vasella said. If Zelnorm comes back in a restricted form, it "won't be commercially attractive," he added. "But that's not the question."

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