How to file a Zelnorm Lawsuit
Zelnorm is brand name for tegaserod maleate. It is used to treat constipation and irritable bowel syndrome in women. In irritable bowel syndrome abdominal pain occurs frequently with constipation or diarrhea. It is also used to treat irritable bowel syndrome in women where constipation is accompanied by severe stomach pain. It is also used to treat severe constipation in patients below 65 years of age. It acts by increasing action of serotonin in intestine. Serotonin is a chemical, which affects bowel movement. In constipation contraction in intestine is less. It helps Serotonin to increases contraction in intestine and results in relief from constipation.
Use of this drug can produce side effects such as headache, dizziness or migraine, back pain or joint pain and mild stomach pain, nausea or gas. It can also result in increased stomach pain, blood in stools, ongoing diarrhea, severe stomach pain or cramps or feeling like fainting. This drug has been related to heart injuries. It has been accused of causing heart related injuries in patients using it. An FDA safety analysis of data, which was collected from 29 clinical trials and was involving over 18,000 patients, revealed its relation to cardiovascular problems. 11,614 patients were treated with Zelnorm and 7,031 treated with a sugar pill. The average age of patients in these studies was 43 years and around 88% were women. Study found an excess number of serious cardiovascular problems occurring in patients, who used Zelnorm. These problems were angina, heart attacks and stroke. It has forced the pharmaceutical company to recall Zelnorm in 2007.
Zelnorm is manufactured by Novartis; a New Jersey based pharmaceutical company. It was approved by the U.S. Food and Drug Administration for treatment of irritable bowel syndrome (IBS) with constipation in women in 2002. Later it got approval for treatment of chronic idiopathic constipation (CIC) in 2004. Recall of Zelnorm led to many lawsuits against Novartis related to side effects of Zelnorm. Studies also backed claims of heart injuries caused by use of this drug. The major side effects produced by this drug are angina, heart attack, stroke, ischenic colitis and severe diarrhea.
Who can file a Zelnorm Lawsuit?
Any person who or any person related to him or her who has suffered severe side effects due to use of Zelnorm can file a lawsuit. Patients who suffered due to use of this drug can sue Novartis for creating and marketing an unsafe drug.
Many Zelnorm lawsuits accuse Novartis that it was aware of the fact that use of Zelnorm could lead to severe and even fatal side effects, but hid this information from patients as well as healthcare practitioners. This drug has been previously denied approval in many countries including U.S. this was due to safety concerns. This fact strengthens the lawsuits against Zelnorm.
Zelnorm lawsuits’ claims of severe side effects are backed by different studies, which showed its fatal effects. FDA safety study also revealed that Zelnorm users were ten times more likely to suffer cardiovascular problems compared to patients having other placebo drugs. The FDA also reported severe diarrhea and ischemic colitis in many patients. Some of the patients even died.
Basis of the Lawsuit
Zelnorm Lawsuits can be filed on basis of failure to warn. Many lawsuits already filed accused Novartis of failing to warn the public about Zelnorm side effects. Lawsuits claim that Novartis was aware of fatal side effects of this drug but did not warned patients and doctors until it was forced by FDA to recall this drug.
What one can ask for in the Lawsuit?
Any Zelnorm sufferer, who is filing a lawsuit against Novartis, can seek for medical bills occurred as well as compensation for pain and suffering, lost work and mental anguish. In some cases future medical expenses may also be asked for.