Popular IBS Drug Falls Short of Expectations

The chronic condition known as irritable I bowel syndrome(IBS) affects up to 20% of the population. Symptoms include diarrhea and/or constipation, abdominal pain, cramping, gas and nausea.

In 2002, tegaserod (Zelnorm) was approved by the US Food and Drug Administration (FDA) for the short-term treatment of IBS in women who experienced constipation. Since then, it has been prescribed for 68% of IBS cases in the US, according to the drug's manufacturer, Novartis.

Is Zelnorm the drug that women who have IBS have been waiting for?

First, it's important to understand that Zelnorm was approved only for the short-term treatment of female IBS patients whose main symptom is constipation (hard stools or difficulty passing stools). Women who have diarrhea should not use Zelnorm because it can worsen this condition.

Zelnorm has never been shown to be effective for men who have IBS, but it is used for chronic idiopathic (from an unknown cause) constipation in men and women younger than age 65. Also, it is not recommended for people who have a history of bowel obstruction and/or gallbladder disease because it can worsen both conditions.

Zelnorm is one of a new class of drugs called serotonin-4 receptor agonists, which activate receptors for serotonin, a relaxing neuro transmitter, in the digestive tract. This action is thought to normalize digestive tract movement.

Studies involving Zelnorm show a mild benefit, such as improved bowel movements and reduced abdominal pain, discomfort and bloating, but the drug's long-term safety and effectiveness have not been established. The most common side effects include headache, abdominal pain, diarrhea, nausea and dizziness.

In April 2004,the FDA warned people to stop taking Zelnorm immediately if they developed rectal bleeding, bloody diarrhea or new or worsening abdominal pain. These are symptoms of intestinal ischemia, a potentially fatal condition in which the supply of blood and oxygen to the intestines is compromised. The FDAs caution was based on information from clinical trials and "post marketing reports." This means that, essentially, people who had taken Zelnorm just as those who take other new drugs-had unwittingly served as guinea pigs to determine the drug's side effects.

A Better Option

In summary, Zelnormhas undergone no long-term studies, has the potential for some very serious side effects and has not been shown to be effective in men or in patients who have diarrhea associated IBS. I believe most people can find better relief with nontoxic natural therapies.

IBS is a disease of modern times, which are marked by fast food, high stress and the overuse of drugs. (Antibiotics and steroids, in particular, destroy "friendly" bacteria that help digest food.)

I have found that natural therapies for IBS have a very high success rate in both men and women. I'm confident that the benefits of a holistic approach using a healthful (high-fiber, low-sugar) diet, nutritional supplements that aid digestion (probiotics, enzymes and digestive herbal tonics) and stress-reduction techniques (exercise, prayer and counseling) far exceed the mild benefits of Zelnorm. And, of course, the drug's serious side effects would not be an issue using a natural approach.

In my opinion, Zelnorm is a waste of time and money and not worth the risk. Save the $170 you would spend on Zelnorm each month and invest it instead in healthful food and supplements that aid digestion.