Sad news for patients who suffer from constipation predominant irritable bowel syndrome (IBS –C) and chronic idiopathic constipation (CIC). Novartis, the manufacturer of Zelnorm, has decided to terminate its restricted access program which provided the medication to patients who met strict eligibility requirements.

Zelnorm had the distinction of being the only drug that was authorized by the FDA for the treatment of IBS-C and CIC. Zelnorm was thought to work by increasing serotonin in the gut’s enteric nervous system. Unfortunately, in March of 2007 the FDA instructed Novartis to stop marketing and selling Zelnorm due to an identified increased risk of heart attack, stroke, and angina. In response to patient demand, the manufacturer agreed to allow the prescription of Zelnorm to certain patients under very restrictive conditions. Under the restricted access program, Zelnorm could only be prescribed to women under the age of 55 who were diagnosed with IBS-C or CIC and who had no risk factors for cardiovascular problems and had not found relief from any other available form of treatment. It is this restricted access program that has been terminated.

As of this month, Novartis has announced that Zelnorm will now only be available for emergency situations and its prescription must be authorized by the FDA. The FDA defines an emergency as a condition that is “immediately life threatening or serious enough to qualify for hospitalization”. However, even in these circumstances, the FDA retains the right to deny authorization if there is any evidence of other risk factors, such as cardiovascular disease, anxiety and depression, smoking and diabetes.

Access to Zelnorm is now handled by the FDA. Physicians can visit druginfo@fda.hhs.gov to get information as to how to apply for emergency authorization. If the FDA gives the okay, Novartis will then ship the medication to the physician.

Are you personally affected by this decision? Please post to the IBS forum and tell us about your experience. For information on other medication options, see:

• Prescription Medication for Constipation Predominant Irritable Bowel Syndrome
• Miralax vs. Zelnorm

Source:

Zelnorm (tegaserod maleate) Information. US Food and Drug Administration Center for Drug Evaluation and Research, April, 2008.