Source | Associated Press

The Swiss pharmaceutical maker Novartis AG will stop selling a drug designed to relieve constipation after it was linked to a higher risk of heart attack, stroke and worsening chest pain that can become a heart attack, federal health officials said yesterday.

Novartis agreed to withdraw Zelnorm at the FDA’s request, the agency said.

Zelnorm, also called tegaserod maleate, is a prescription medication approved for the short-term treatment of women with irritable bowel syndrome, as well as of men and women younger than 65 with chronic constipation, the FDA said.

Doctors should work with patients who take Zelnorm to help them switch to other therapies, the FDA added.

Earlier this year, Novartis gave the FDA the results of 29 clinical studies of Zelnorm as used in the treatment of a variety of gastrointestinal conditions. The analyses showed that 13 of 11,614 patients given Zelnorm experienced serious and life-threatening cardiovascular side effects, while only one of the 7,031 patients given placebos did.

FDA officials described the cardiovascular side effects as “a very rare event.” Still, “we concluded the benefits of this drug no longer outweighed the risks for patients,” said John K. Jenkins, director of the FDA’s Office of New Drugs.

Novartis said it believes the drug provides unique benefits.

“Although we have complied with the FDA’s request and are collaborating with the agency, we continue to believe that Zelnorm provides important benefits for appropriate patients,” said Stephen Cunningham, vice president and head of U.S. clinical development and medical affairs at Novartis.

The FDA first approved Zelnorm in 2002.

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Source | FDA

FDA is issuing this public health advisory to inform patients and health care professionals that the sponsor of Zelnorm (tegaserod maleate), Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm.  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.

Zelnorm is a prescription medication approved for short term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years with chronic constipation.   In late February and early March 2007, Novartis Pharmaceuticals gave FDA the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions; the data from all the studies were combined to assess the chance of side effects on the heart and blood vessels.  In each study, patients were assigned at random to either Zelnorm or a sugar pill they thought was Zelnorm.  These 29 studies included 11,614 patients treated with Zelnorm and 7,031 treated with a sugar pill.  The average age of patients in these studies was 43 years and most patients—88%–were women. 

The number of patients who suffered a heart attack, stroke or severe heart chest pain that can turn into a heart attack was small.  However, patients treated with Zelnorm had a higher chance of having any of these serious and life-threatening side effects than did those who were treated with a sugar pill.  Thirteen patients treated with Zelnorm (0.1%) had serious and life-threatening cardiovascular side effects; among these, four patients had a heart attack (one died), six had a type of severe heart chest pain which can quickly turn into a heart attack, and three had a stroke.  Among the patients taking the sugar pill, only one (or 0.01%) had symptoms suggesting the beginning of a stroke that went away without complication.

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 for those patients through a special program.

FDA has also 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 whom the benefits of the drug outweigh the risks.  However, before FDA makes a decision about limited re-introduction, any proposed plan would be discussed at a public advisory committee meeting. 

Do I Have a Zelnorm Lawsuit?

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular (heart attack, stroke, angina) or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.

Click Here - Free Confidential Case Evaluation: Zelnorm Lawsuit

Source | FDA 

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.

Zelnorm is a prescription medicine approved 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.

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.

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 information, visit http://www.fda.gov/cder/drug/advisory/tegaserod.htm

####Do I Have a Zelnorm Lawsuit?

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular (heart attack, stroke, angina) or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.

Click Here - Free Confidential Case Evaluation: Zelnorm Lawsuit