Zelnorm Side Effects

On March 30, 2007 the FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing Zelnorm, a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data pooled from 29 clinical trials involving over 18,000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelnorm compared to patients given placebo. Patients taking Zelnorm should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate.

Zelnorm (tegaserod) is a prescription drug for the short-term treatment of women with irritable bowel syndrome (IBS). Zelnorm is intended primarily to treat the constipation that accompanies IBS. (It has never been tested in men.)

The FDA based its decision to approve Zelnorm on the results of three randomized, double-blind, placebo-controlled clinical studies each lasting 12 weeks. In these clinical trials, the most common possible side effects of Zelnorm were: abdominal pain; headache; diarrhea; nausea; gas; back pain; indigestion; upper respiratory tract infection; flu-like symptoms; sinusitis; urinary tract infection. A slight increase in abdominal surgeries (particularly gall-bladder removal) among Zelnorm users was noted during one of the trials.

The FDA was expected to approve Zelnorm one whole year before it actually did. This anticipated approval was abruptly halted as a result of concerns about an increase in gallbladder and other abdominal operations among patients testing the drug. European regulators raised similar concerns. Post-approval, the FDA has ordered Novartis to study how patients fare as sales begin, and pledged to closely monitor any reports of side effects.
In March 2006, a panel of European experts rejected Zelnorm for the European market for the second time, after re-examining the evidence following the initial December 2005 rejection of the drug.

The CHMP was concerned that the results of the study would not translate into real benefit to the patient treated to relieve the symptoms of this disorder in standard health care setting. The CHMP was of the opinion that Zelnorm’s benefits are not greater than its risks. Hence, the CHMP recommended that Zelnorm be refused marketing authorisation.
The London-based European Medicines Agency said the committee had reiterated the decision from December not to recommend Zelnorm for the relief of irritable bowel syndrome in women with constipation.

Zelnorm Attorney :: Zelnorm Lawyer

Zelnorm cardiovascular side effects lawsuit:

The maker 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 ischemic colitis, 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. If you feel you may have a case, please submit a free consultation here to be reviewed by a Zelnorm attorney.

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 to prevent a Zelnorm heart attack or stroke.

• 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 Zelnorm 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 for treatment of irritable bowel syndrome with constipation in patients younger than 65 years with chronic constipation. In 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. In each study, patients were assigned at random to either Zelnorm or a sugar pill they thought was Zelnorm.

The number of patients who suffered a Zelnorm 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.