FDA WITHDRAWL, FINANCIAL COMPENSATION, ALTERNATIVE MEDICATIONS
Zelnorm is manufactured by Novartis Pharmaceutical Corporation. The medication was approved by the Federal Drug Administration (FDA) in July 2002 for treatment of irritable bowel syndrome (IBS) and severe constipation. In March 2007, the FDA halted the sale of Zelnorm be halted as a result of safety concerns when research demonstrated that the IBS drug significantly increased risk of heart attacks, strokes, angina and death.
FDA Withdraws Drug From the Market
The FDA recommended that Zelnorm be removed from the market after reviewing data from 29 different clinical trials involving over 18,000 patients. Analysis demonstrated that users of Zelnorm experience heart attacks, strokes and angina at a rate 7 to 8 times greater than those who took a placebo. The FDA determined that the risk of heart attack, stroke, serious injury or death far outweighs the benefits of treating a non-life threatening irritable bowel syndrome. Click Here to see the FDA Public Health Advisory for Zelnorm.
Did the Manufacturer Know that Zelnorm was Dangerous?
There was significant clinical data which we believe indicates that the company knew or should have know that the drug was dangerous and should have been withdrawn from the market. The manufacturer, Novartis, failed to warn that the use of the medication is associated with this high number of serious cardiac events.
Zelnorm was one of the top 200 most prescribed brand-name medications in the United States, with over 2.6 million prescriptions written during 2006. The IBS drug generated sales of $561 million worldwide in 2006, with $488 million from sales in the United States. With such significant profit being generated for the manufacturer, many suspect that Novartis' failure to properly warn of the dangers of Zelnorm resulted inprofits being placed before patient safety.
Side Effects Associated with Zelnorm include:
- Heart Attacks
- Angina (chest pain)
- Gastrointestinal Injuries
- Ischemic Colitis (inflammation of the colon)
FDA Public Health Advisory
Tegaserod maleate (marketed as Zelnorm)
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.