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http://www.nytimes.com/2002/07/25/health/25FDA.html

Drug to Treat Bowel Illness Is Approved by the F.D.A.

By ANDREW POLLACK

he Food and Drug Administration yesterday approved the first drug for women with a form of irritable bowel syndrome, an often painful disorder that afflicts millions of Americans.

The drug, Zelnorm, made by the Swiss pharmaceutical giant Novartis International, was approved for short-term use by women with irritable bowel syndrome characterized by constipation, a group that an F.D.A. official said could number 3.7 million. The drug's effectiveness in men, who are less likely to develop irritable bowel syndrome, has not been established by clinical trials.

While patients can take laxatives or painkillers approved for other uses, Zelnorm is the first drug specifically approved for this form of the syndrome and the first that the drug agency says can reduce not only constipation but pain and bloating as well.

Another drug, Lotronex, was reapproved last month for another form of the syndrome, that one with diarrhea, after having been withdrawn over safety concerns.

Yesterday's action met with mixed reviews.

"I think this is a drug that fills an unmet need for a lot of folks with an important problem," said a consultant to Novartis, Dr. Walter L. Peterson, a professor at the University of Texas Southwestern Medical Center, in Dallas.

But a frequent critic of the drug agency, Dr. Sidney M. Wolfe, director of the Public Citizen Health Research Group, in Washington, said Zelnorm appeared to increase the risk of developing ovarian cysts. Dr. Wolfe also said the drug was only marginally effective and added that patients could instead take Metamucil, a popular over-the-counter laxative.

"Given how barely effective the drug is and the fact that there are alternatives available," he said, "it would seem to be a very bad decision on the part of the F.D.A."

Dr. Joyce Korvick, deputy director of the F.D.A. division overseeing gastrointestinal drugs, said the concern about ovarian cysts was unwarranted. Dr. Peterson, the Novartis consultant, also said that there was no increased risk of cysts, and added that Metamucil had not been shown effective for all irritable bowel symptoms.

There does seem to be great demand for treatments for irritable bowel syndrome, as shown by the uproar over Lotronex, made by GlaxoSmithKline. That drug was taken off the market late in 2000, less than 10 months after its approval, because it had been linked to serious side effects and a few deaths.

But thousands of patients pleaded with the F.D.A. to allow Lotronex back on the market, saying they could not lead a normal life without it. Last month, the agency did reapprove it, though with new restrictions on its use.

The agency said last year that Zelnorm would not be approved, because it seemed linked to an increase in abdominal surgery, particularly gallbladder removal. But Novartis provided more data showing that some of the patients had planned their operations before starting on the drug, said Dr. Korvick, of the F.D.A.

In three clinical trials, the patients who reported after three months that the drug had relieved their symptoms ranged from 39 percent to 44 percent. That was 5 to 11 percentage points greater than those who reported relief from a placebo. The biggest side effect of the drug was diarrhea, which generally went away.

Zelnorm will be sold only by prescription. "This isn't like you go down to your corner store and buy a laxative," Dr. Korvick said.

Further, the agency's approval is limited: the F.D.A. is recommending it only for women, who, it says, should take it for only four to six weeks to start, because there are no data from clinical trials on the effects of use beyond 12 weeks. Once a drug is approved, however, doctors are free to prescribe it for other uses, or other patients.

Daniel Vasella, chairman and chief executive of Novartis, said the company was also doing studies to see whether Zelnorm could be used to treat general chronic constipation and heartburn. But he said worldwide sales of the drug could reach $500 million to $1 billion a year for irritable bowel syndrome alone.

Zelnorm has now been approved by more than 30 countries, including Canada and Australia, though not by the European Union, which is requiring another clinical trial.

Nancy Norton, founder and president of the International Foundation for Functional Gastrointestinal Disorders, a patient group in Milwaukee, applauded the F.D.A.'s action.

"This really has been a population that has been underserved for decades," she said.

Zelnorm, known generically as tegaserod maleate, is to be taken twice a day, as a pill. Novartis said the drug should be available in the fall and was likely to cost $3 to $4 a day.

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