- The Washington Times - Friday, March 30, 2007

The manufacturer of the popular drug Zelnorm, used to treat constipation, pulled the product from the U.S. market yesterday at the request of federal officials who said it had been linked to an increased risk of heart attacks and strokes in rare cases.

The Food and Drug Administration released a public health advisory yesterday saying Novartis Pharmaceuticals Corp., a Swiss drug maker, had agreed to stop selling Zelnorm. Zelnorm was approved by the FDA in 2002 and accounted for $561 million in U.S. sales last year.

Zelnorm is being taken off the market because a new safety analysis found a higher chance of heart attack, stroke and worsening heart chest pain than previously thought, the FDA said.

Zelnorm is a prescription medication approved for short-term treatment of women with constipation and was approved for patients younger than 65 with chronic constipation. About 500,000 people are taking Zelnorm, with an estimated 12 million Americans suffering from symptoms related to the problem.

The FDA’s request to remove Zelnorm from the market resulted from test results Novartis submitted to the FDA earlier this year. The results showed that 13 of 11,614 patients given Zelnorm had serious and life-threatening cardiovascular side effects. All patients treated in the study had a pre-existing cardiovascular disease.

FDA officials described the cardiovascular side effects as “a very rare event,” but decided to request the removal because the agency concluded the benefits of Zelnorm “no longer outweighed the risks for patients with constipation,” said Dr. John K. Jenkins, director of the FDA’s Office of New Drugs.

Novartis said it is standing behind the drug’s benefits.

“Although we have complied with the FDA’s request and are collaborating with the agency, we continue to believe that Zelnorm provides important benefits for appropriate patients,” said Dr. Stephen Cunningham, vice president and head of U.S. clinical development and medical affairs for Novartis.

The FDA told Novartis it would consider allowing a limited reintroduction of Zelnorm “if a population of patients can be identified in whom the benefits of the drug outweigh the risks,” the agency said. And, for patients with no treatment options other than Zelnorm, the FDA said it would work with Novartis to allow access to the drug for those patients through a special program.

Zelnorm also will no longer be sold in Canada. It will remain on the market in Switzerland.

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