Practical Practitioner

By: Pamela Egan, FNP-C CDE

Zelnorm deemed safe for IBS constipation

Dear Pam,

I’m in my mid-40s, have had three children, and suffer with severe constipation. Laxatives and stool softeners are just not working. What else can I do?

This is one of the most frequent complaints among women in our Family Practice Clinic. You may find that a simple change of diet works wonders. Many people feel better after cutting some fat from their meals. Drink eight full glasses of water, increase your fiber intake 20 or 30 grams (fruits, vegetables, fiber supplements) and exercise every day. If your bouts of IBS go hand-in hand with stress and anxiety, you may need to learn how to relax and cope with your feelings. If necessary, your healthcare provider can prescribe medication to help control your symptoms.

Zelnorm (known as Zelmac in Europe) is a new medicine for the short-term treatment of women who have irritable bowel syndrome with constipation (not enough or hard bowel movements) as their main bowel problem. Women with this medical condition suffer from abdominal (stomach) pain or discomfort, bloating and constipation. Zelnorm does not work for all women that use it and has not been shown to work in men with IBS.

Zelnorm increases the movement of stools (bowel movement) through the bowels. Zelnorm does not cure IBS. For those who are helped, Zelnorm reduces pain and discomfort in the abdominal area, bloating and constipation. If you stop taking Zelnorm, your IBS symptoms may return within one or two weeks.

The term “irritable bowel syndrome” refers to a collection of symptoms with no obvious cause. It is not a disease, but a syndrome – a group of symptoms that occur together. People with IBS frequently develop cramping pain in the lower abdomen along with either diarrhea or constipation. Typically, the pain flares up after a meal and goes away after defecation. Many people also experience gas, bloating, small stools or mucus in the stool. The cause of IBS is thought to result from a communication breakdown between the nerves and muscles that control the colon. The contractions can become sluggish, setting the stage for constipation. The colon also becomes extremely sensitive and even normal contractions can cause considerable pain.

Doctors who tested the newly approved drug say Zelnorm is safe for at least 12 months of use for the constipating form of irritable bowel syndrome.

But not everyone agrees. Concerns that the drug might cause gallbladder problems held up approval for a year. Those fears proved groundless.

The consumer watchdog group Public Citizen unsuccessfully petitioned the FDA to deny approval. It says the drugs small benefit in clinical trials doesn’t justify the risk of possible side effects. And the group points to evidence that ovarian cysts could be a rare but serious side effect. One reason for concern is recent history.

Zelnorm affects the serotonin system, a complex series of chemical signals that keep the body in synch.

Two other digestive system drugs that affect this same pathway system recently ran into problems. Propulsid was taken off the market when it turned out to harm the heart. And Lotronex, a drug for IBS diarrhea, can cause life-threatening constipation.

This article was originally published November 4, 2002 in The St. Tammany News.

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