ZELNORM

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1.  What is FDA announcing today?

FDA is announcing that Novartis Pharmaceuticals has agreed to FDA’s request that they voluntarily discontinue marketing and sales of Zelnorm (tegaserod maleate).  FDA’s request was based on newly available information of an increased risk of serious cardiovascular adverse events, including myocardial infarction (heart attack), unstable angina (chest pain), and stroke, associated with use of the drug.  Based on this new information, FDA has concluded that the overall risk versus benefit profile for the drug is unfavorable for continued marketing.  

2.  Why Will Marketing of Zelnorm be discontinued?

FDA was informed by Novartis on February 22, 2007, of an increased cardiovascular risk detected in a pooled analysis of 29 short-term (e.g., 1-3 months), randomized, controlled clinical trials involving over 18,000 patients.  The pooled analysis demonstrated a higher risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm compared to placebo treatment.  While the overall number of serious cardiovascular adverse events reported was small, patients treated with Zelnorm were more likely to have these adverse events than patients treated with placebo.  The pooled analysis included over 11,600 patients treated with Zelnorm and over 7,000 patients treated with placebo.  There were 13 Zelnorm-treated patients (or 0.1%) with confirmed cardiovascular ischemic events, and only 1 placebo-treated patient (or 0.01%) with an event. FDA has concluded, based on these data, that the benefits of this drug no longer outweigh the risks.   After completing its review of these data, FDA asked Novartis on March 28, 2007, to discontinue marketing of Zelnorm.

3. What is Zelnorm?

Zelnorm is a medicine used for the short-term treatment of women who have irritable bowel syndrome with constipation (IBS-C) as their main bowel problem.  IBS is a disorder that interferes with the normal functions of the large intestine (colon). Symptoms may include cramps, abdominal pain, bloating, constipation, and/or diarrhea.  The cause of IBS is not known.  Zelnorm works by increasing the movement of stools through the bowels.  For those patients who are helped, Zelnorm reduces pain and discomfort in the abdominal area, bloating, and constipation.

Zelnorm is not a cure for IBS and does not work for all women who use it.  FDA does not have evidence that Zelnorm is effective in men with IBS-C.

4.  What is IBS?

IBS is a disorder that interferes with the normal functions of the large intestine (colon).  Symptoms may include cramps, abdominal pain, bloating, constipation, and/or diarrhea.  IBS causes lower abdominal pain and discomfort, urgency (a sudden need to have a bowel movement), and irregular bowel habits, such as diarrhea or constipation. In some people IBS causes mostly constipation; in others, it causes mostly diarrhea; some people have alternating periods of diarrhea and constipation. Zelnorm was approved only for women with constipation-predominant IBS. Zelnorm should not be used by women who have diarrhea as their main IBS symptom. IBS is a symptomatic disease that can cause significant discomfort.

5.  What is Chronic Idiopathic Constipation?

Chronic idiopathic constipation is a disease which requires clinical tests to be performed to rule-out serious causes of constipation.  Patients are considered to have chronic constipation if they have less than 3 complete spontaneous bowel movements per week and at least one of the following symptoms for at least 25% of defecations: straining, hard stools, incomplete evacuation.  This medical problem can be seen in men and women.

6.  What previous actions have FDA and the manufacturer taken?

In April 2004, major changes were made to the Zelnorm professional label (package insert), including a new warning about serious consequences of diarrhea, a new precaution about ischemic colitis and other forms of intestinal ischemia.  In addition, the updated label for patients included information about the potential side effects and advised patients to stop taking Zelnorm and contact their doctor if they experienced certain symptoms.  A Talk Paper, Questions and Answers, and a Patient Information Sheet were issued at the time of the label changes.  A Dear Healthcare Practitioner Letter was issued by Novartis regarding these safety issues.

7.  What is Zelnorm approved for?

Zelnorm was approved on July 24, 2002, for short term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation.  

On August 21, 2004, FDA approved Zelnorm or another use, the indication of chronic idiopathic constipation.   

8.  What should I do if I am currently taking Zelnorm?

We encourage those people who are taking Zelnorm to contact their doctor and discuss appropriate alternative treatments.

Patients who are taking Zelnorm should seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke. 

9.  Will Zelnorm be recalled from the pharmacy?

Novartis plans to recall Zelnorm and will actively work to remove it from pharmacies.

10.   What should I do with the Zelnorm I have left in my home?
Novartis plans to allow patients to return their unused Zelnorm for reimbursement.  You should contact Novartis for further information about the proper procedure for returning unused drug.  There contact telephone number is provided in Question 15.

11.  Will there be any way for patients to receive Zelnorm?

FDA will work with Novartis to open a treatment protocol (treatment IND) to allow access to Zelnorm for patients with no other treatment options where the benefits may outweigh the risks. 

In addition, FDA has indicated to Novartis a willingness to consider limited re-introduction of Zelnorm at a later date if a population of patients can be identified in which the benefits of the drug outweigh the risks.  Any such request for reintroduction would be discussed at a public advisory committee meeting before an FDA decision.
 
12.  Is Zelnorm approved in other countries?

The drug is available in other countries under the name Zelmac.  It is approved in Switzerland, Canada and Australia as well as 52 other countries.  

13.  How can I report a serious side effect with Zelnorm to FDA?

FDA encourages anyone aware of a serious adverse reaction, including consumers, to make a Med Watch report.

You can report an adverse event in two ways:
Visit www.fda.gov/medwatch and click on "How to Report"
Call 1-800-FDA-1088

14.  Who manufactures Zelnorm?

Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ  07936-1080

15. Where can I get more information relating to the discontinuation of Zelnorm?

To find out more about Zelnorm from FDA:
Visit our Drug Information web page at: www.fda.gov/cder
Call Drug Information at: 888-INFO-FDA (888-463-6332)

To contact Novartis Pharmaceuticals:
Call  (888)-NOW-NOVA (888-669-6682)

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