Zelnorm Recall
April 27, 2004FDA calls for tougher warnings on Zelnorm
A number of patients taking the irritable bowel syndrome (IBS) drug Zelnorm have suffered from diarrhea so severe that they required hospitalization. As a result, the Food and Drug Administration has ordered a change to the drug’s label to warn patients of the risk of this side effect of Zelnorm.IBS is a serious abdominal condition affecting mostly women which causes abdominal pain and either severe diarrhea or constipation. Zelnorm was approved by the FDA in 2002 to treat the constipation type of the disease. It has only been approved for the short-term treatment of IBS in women.
Because Zelnorm is designed to increase the movement of stool through the colon, diarrhea is a potential side effect of thee drug. The FDA has received 21 reports of patients who have suffered from diarrhea so severe as to cause low blood pressure and fainting. Some of these patients had to be hospitalized as a result of their Zelnorm side effects. Officials from the FDA say that anyone who suffers from chronic diarrhea, dizziness or fainting should not use Zelnorm.
In addition, the FDA has received 20 reports of patients who were diagnosed with ischemic colitis (colon inflammation) and three more with a similar intestinal problem. Fourteen of these patients were hospitalized and four died, which may have been the result of their Zelnorm side effects.
The FDA says that any patients who experience new or more severe abdominal pain—which could be a symptom of ischemic colitis—after using Zelnorm should discontinue use and see a doctor.