The Food and Drug Administration (FDA) today announced the addition of new risk information to the health professional labeling for Zelnorm (tegaserod maleate). Zelnorm is a prescription medication for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation. The labeling is being revised to ensure health professionals and patients have the most current and complete information available when prescribing and taking Zelnorm.
The specific revisions include:
- a new warning about the serious consequences of diarrhea associated with the medication;
- a new precaution about ischemic colitis and other forms of intestinal ischemia (i.e., reduced blood flow to the intestines);
- changes to the adverse reactions section describing post-marketing reports; and
- new information in the "Information for the Patient" leaflet.
The new warning states, "Serious consequences of diarrhea, including hypovolemia, hypotension and syncope have been reported in the clinical studies and during marketed use of Zelnorm. In some cases, these complications have required hospitalization for rehydration. Zelnorm should be discontinued immediately in patients who develop hypotension or syncope. Zelnorm should not be initiated in patients who are currently experiencing or frequently experience diarrhea."
The new precaution on ischemic colitis states, "Ischemic colitis, and other forms of intestinal ischemia, have been reported in patients receiving Zelnorm during marketed use of the drug. A causal relationship between Zelnorm use and these events has not been established. Placebo-controlled clinical trials of 7,000 patients for 3-month duration showed no cases of these events, and would suggest the rate of these events is low. Zelnorm should be discontinued immediately in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea or new or worsening abdominal pain. Patients developing these symptoms should be evaluated promptly and have appropriate diagnostic testing performed. Treatment with Zelnorm should not be resumed in patients who develop findings consistent with ischemic colitis."