Real Help for Irritable Bowel Syndrome
Editor's Note: In March 2007 the FDA asked Novartis -- the maker of
Zelnorm -- to pull the drug from the market because of evidence that it raises
the risk of heart attacks and stroke. But in July 2007 the FDA ruled that
Zelnorm may be used by some patients in critical need of the drug who do not
have heart problems.
May 23, 2001 (Atlanta) -- It seems it's been all bad news
lately for people with irritable bowel syndrome. Lotronex, the drug with so
much hope, was voluntarily removed from the market this past November after
some patients experienced life-threatening side effects, and before that
Propulsid -- which was linked to serious heart problems -- became unavailable
this past July. But now, things are looking up.
This week, researchers at the Digestive Disease Week conference
here presented new findings that could mean relief for the one in five
Americans suffering from the pain, bloating, diarrhea, and constipation of
According to Martin Lefkowitz, MD, "there is no proven
effective therapy for the group of IBS patients with abdominal pain, bloating,
and constipation." But within a week of being on a new drug called Zelnorm,
"these patients had significantly less discomfort and improved quality of
life," he says.
After a four-week observational period, Lefkowitz' team
randomly assigned more than 1,500 female volunteers with IBS to a 12-week
course of twice-daily Zelnorm or placebo. The women all had moderate to severe
abdominal pain and three or more bowel movements per week, usually with
Zelnorm "stimulates motility or movement of the digestive
tract, stimulates intestinal secretions, and inhibits visceral sensitivity or
the perception of pain," says Lefkowitz. He is director of clinical
research at Zelnorm manufacturer Novartis Pharmaceuticals Corporation, in East
The new drug works by mimicking the effects of the naturally
occurring chemical called serotonin, says Lefkowitz. Lotronex, in contrast, did
essentially the opposite. It inhibited the action of serotonin and was
recommended for IBS patients whose primary complaint is diarrhea.
Considerably more patients in the Zelnorm group than in the
placebo group reported complete or considerable relief from IBS symptoms, and a
significant increase in their overall sense of well-being. "Zelnorm twice a
day results in rapid improvement of multiple IBS symptoms," and the effect
lasted as long as they continued the medication, he tells WebMD.
So far, extensive research has revealed no worrisome side
effects with the drug. The most common problems have been headache and nausea.
"There was a two-fold increase in diarrhea in about 6% of those taking
Zelnorm, but it resolved by itself, did not cause dehydration, and most
patients were able to continue in the study," says Lefkowitz. Even so, he
cautions that anyone whose IBS symptoms include diarrhea should not take the