Small Window of Opportunity for Zelnorm

Cambridge, MANormally, in business, the five-year window represents a long-held expectation for the first tangible signs of success. But such is not the case for Zelnorm. Even though the manufacturer, Novartis Pharmaceuticals made money hand-over-fist with Zelnorm and won marketing accolades, the drug peaked, then faded from view in the time it takes for many businesses just to get established.

Zelnorm was pulled from the market after five years. Any further appearance of the product may well be in the courts, although a small door has been left open for it's potential return.

The U.S. Food and Drug Administration (FDA) approved Zelnorm on July 24, 2002 for the treatment of Irritable Bowel Syndrome (IBS). The drug was the only product of its kind approved for the treatment of IBS primarily in women suffering from compacted stools. Zelnorm was designed to ease hard stools through the bowels, and was considered appropriate for short-term use only.

However, Zelnorm may have worked just a little too well for some, as two years later in 2004 the FDA stepped forward to update the Zelnorm product labelling to include warnings about the potential for serious diarrhea, and the consequences stemming from it. Some patients experienced severe dehydration, and many were hospitalized.

Then came the news in March of this year that Zelnorm, the commercial name given to tegaserod maleate, carried a heightened risk for heart attack and stroke. Data submitted to the FDA from the manufacturer found that while the incidence rate was small, the risk was nonetheless present, and higher than with those patients taking a placebo for benefit of the study.

The average age of study participants ingesting Zelnorm was 43, and most - 88 per cent - were women.

Of the 11,614 Zelnorm recipients, thirteen developed life-threatening cardiovascular side effects. Among them, four suffered heart attacks and one died.

On March 30th of this year the FDA issued a public health advisory announcing that Novartis Pharmaceuticals had agreed to remove Zelnorm from the market, and other countries are taking the FDA's lead. Canada followed suit the same day. On May 30th Swissmedic, the Swiss medical watchdog, issued a complete market withdrawal of Zelnorm in Switzerland barely seven months after the drug received regulatory approval in that country.

China fell in two weeks later. Zelnorm was originally marketed in 55 countries.

The complexity and mystery surrounding IBS makes the loss of Zelnorm that much harder to accept for those who suffer intense symptoms, and the relative lack of alternatives. Aside from one woman who found her answer via a $5 over-the-counter children's laxative sold at Wal-Mart, there is precious little relief for patients dealing with severe IBS.

That said, the FDA has not closed the door on Zelnorm completely.

In its recommendations released March 30th, the FDA admitted the conundrum for those patients "...for whom no other treatment options are available and in whom the benefits of Zelnorm treatment outweigh the chance of serious side effects," quoting the release. "FDA will work with Novartis to allow access to Zelnorm for those patients through a special program."

The FDA has also indicated to Novartis that the Agency would consider "limited re-introduction of Zelnorm at a later date if a population of patients can be identified in whom the benefits of the drug outweigh the risks."

In other words, you'll be able to poop when you need to.

But the heart attack you might otherwise not have had, could kill you.

Zelnorm earned U.S. $561 million for Novartis last year.