Irritable bowel syndrome and Zelnorm

pill irritable bowel syndromeThe drug tegaserod maleate marketed as Zelnorm by Novartis and widely prescribed for irritable bowel syndrome was withdrawn from the US market in March this year by the US FDA (Food and Drug Administration). This was due to a link between Zelnorm and an increase in “ischemic cardiovascular events”, meaning reduced blood supply to some vital organs particularly the heart and the brain. This can cause heart attacks and strokes respectively.
The FDA has revised its previous ruling to allow access to Zelnorm under certain conditions:

  1. irritable bowel syndrome with constipation and
  2. chronic idiopathic contipation ie constipation for which no cause can be found,

in women under the age of 55 years with no previous history of heart problems.
Revisions of previous restrictions like this are usually made in situations where no other drug or therapy is available to treat a particular condition which may be life-threatening.
Physicians who have patients that meet these criteria have been advised to get in touch with Novartis, the manufacturer of the drug as it is no longer widely available. If you meet these conditions and have have had to stop Zelnorm because of the FDA restrictions, have a chat with your doctor. He may be able to help you revisit your options.

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September 17, 2007 by Ada
Filed under: Health issues 

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