Zelnorm is a prescription medicine that was approved by the FDA in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65. Zelnorm is marketed in 55 countries.

The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States.

But Public Citizen says there's nothing recent about and notes that in March 2001, it petitioned the agency not to approve Zelnorm because it was only marginally effective and posed serious safety concerns. Besides heart problems, risks included ovarian cysts and and a five-fold increase in fainting compared to placebo in patients in clinical trials completed before its approval.

Public Citizen noted in its petition that receptors with which this drug interacts exist not only in the intestinal tract - related to its anti-constipation effects - but also in the heart. They pointed out that cisapride, a gastrointestinal drug which also caused fainting and was taken off the market because of cardiac arrhythmias, also affected this same receptor in the heart.

In 2004, Public Citizen warned readers of their Worst Pills, Best Pills newsletter not to take Zelnorm because of the dangers involved. There were 2.13 million prescriptions issued for Zelnorm in 2005 alone, making it one of the top 200 drugs in the country.

Despite our warnings, the FDA approved a drug with marginal effectiveness in the face of serious questions about its safety - putting at risk the millions of people who have already used it. Today the FDA has asked the company to withdraw the drug from the market only after even clearer evidence of harm. This again raises questions about both the adequacy of the FDA’s pre-approval review and post-marketing surveillance.

What is Zelnorm used for? 

Zelnorm is used for the short-term treatment of women who have irritable bowel syndrome (IBS) with constipation (not enough or hard bowel movements) as their main bowel problem.  Zelnorm has not been shown to work in men with IBS. 

Zelnorm is also used for chronic idiopathic constipation (frequent constipation of unknown cause) in both male and female patients less than 65 years of age.

FDA Public Health Advisory

Zelnorm is being taken off the market because a new safety analysis has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm compared to those treated with a sugar pill they thought was Zelnorm.

FDA announces the following, effective immediately: 

• At FDA's request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm.
• Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
• 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. 
• Physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.

FDA is currently advising patients who are using Zelnorm to contact their health care providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care 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.

"This decision reflects the FDA's commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits," said Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research. "Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary."

Throughout February and March 2007, Novartis reported to FDA the results of a new analysis of 29 short-term (1 - 3 months) randomized, controlled clinical trials of Zelnorm. FDA has concluded, based on these data that for most patients the benefits of this drug no longer outweigh the risks.

The analysis included more than 11,600 patients treated with Zelnorm and over 7000 patients treated with placebo. The data showed that the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm is higher than with placebo treatment. Thirteen Zelnorm-treated patients (or 0.1%) had confirmed cardiovascular ischemic events, and only 1 placebo-treated patient (or 0.01%) with an event.

There may be patients for whom no other treatment options are available and in whom the benefits of Zelnorm treatment outweigh the chance of serious side effects. FDA will work with Novartis to allow access to Zelnorm as an investigational drug for patients with no other treatment options where the benefits may outweigh the risks.

FDA has also indicated to Novartis the possibility of considering 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 proposal would be the subject of a public advisory committee meeting before an FDA decision.

For more detailed information about Zelnorm, ask your healthcare provider or pharmacist.

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