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.
Aug. 24, 2004 -- The FDA has approved a new use for the drug Zelnorm in treating chronic constipation in men and women under the age of 65.
Previously, the drug was approved only for the short-term treatment of women with irritable bowel syndrome (IBS) who had constipation as their primary symptom.
The drug's maker, Novartis Pharmaceuticals, says the FDA cited the results of two, phase III clinical trials in approving wider use of the drug in both men and women under age 65 with chronic constipation from unknown causes.
The 12-week studies included more than 2,600 men and women with chronic constipation or having fewer than three bowel movements per week. The study showed Zelnorm increased the frequency of spontaneous bowel movements and relieved symptoms including straining, hard stool, incomplete evacuation, bloating, and abdominal discomfort.
The new indication for Zelnorm goes beyond what an advisory panel had recommended to the FDA in July. That panel recommended expanded use of Zelnorm on the stipulation that the drug be used only in women and not in men or people aged 65 and over, citing a lack of information on the effects of the drug in men and adults over 65.
Zelnorm and the FDA
Zelnorm was originally approved in 2002 for the short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. The drug works by increasing the movement of stools through the bowels.
In April, the FDA updated labeling information on Zelnorm after it received reports linking the drug to the development of ischemic colitis, a dangerous disorder in which blood supply to the intestine is cut off or severely restricted.
The revised warning label includes information on potential risks, such as:
- A new warning about the serious consequences of diarrhea associated with the medication.
- A new precaution about ischemic colitis and other forms of reduced blood flow to the intestines.
- Changes to side effects information section describing information gathered since the drug was approved in July 2002.
In clinical trials of Zelnorm use in people with chronic constipation, researchers say the only major side effect associated with the drug was diarrhea, which occurred in 9% of those taking Zelnorm versus 4% of those taking a placebo.
Zelnorm is made by Novartis Pharmaceuticals, which is also a WebMD sponsor.