After Zelnorm Withdrawn from Market, FDA Permitting Restricted Use

Limited Access to Zelnorm Granted to Women Under 55 Suffering from IBS

The FDA announced in July 2007 that it will make the Novartis drug Zelnorm available to select patients suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) through a drug program formally known as an investigational new drug protocol (IND).

The treatment IND is a way for the FDA to allow patients with a serious disease such as irritable bowel syndrome with constipation who are not enrolled in a clinical trial to be treated with a drug not approved by the FDA when no comparable or satisfactory alternative drug is available. The specific criteria for eligibility in the treatment IND for Zelnorm are as follows:

• Patients must be women under the age of 55 with irritable bowel syndrome with constipation or idiopathic chronic constipation;
• Patients must not have pre-existing cardiovascular adverse events, including angina, heart attacks, and stroke; and,
• Patients who had satisfactory improvement of their symptoms with prior Zelnorm treatment for IBS-C or CIC; i.e., before the March 2007 Zelnorm recall.

On their MedWatch website, the FDA issued a News Release advising patients and healthcare professionals about the IND guidelines.

Zelnorm was withdrawn from the market in March 2007 following concerns about cardiovascular events such as heart attack and stroke associated with the use of Zelnorm.

Zelnorm will remain off the market for general use.

Read more on our Zelnorm Information Page >>