April 28, 2004-Specific Zelnorm labeling 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 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.
