Zelnorm (known generically as Tegaserod Maleate) is a prescription medication commonly used to treat chronic, severe irritable bowel syndrome (IBS).
Irritable bowel syndrome is a disorder that impedes the normal functioning of the large intestine, with close to 15% of the population affected by the disorder. Zelnorm is primarily prescribed for women whose main IBS problem is constipation. It is manufactured and marketed by Novartis Pharmaceuticals and has been approved by the US Food and Drug Administration (FDA) since August of 2002.
Zelnorm works by increasing the activity level of serotonin in the intestines, effectively speeding the movement of stools through the bowels. For the patients successfully treated with Zelnorm, the medication reduces discomfort, abdominal pain, constipation, and bloating. Zelnorm is not considered a cure for IBS and is ineffective in some cases. Currently, there is no other medication approved by the FDA for the treatment of IBS with constipation.
The most common side effects noted during use of Zelnorm are headache, dizziness, back or joint pain, abdominal pain, nausea, and excessive flatulence. Diarrhea is also a side effect of Zelnorm, mostly occurring during the first week of treatment. Typically, the occurrences of diarrhea diminish over time, but in some cases the diarrhea is severe, leading to dehydration, low blood pressure, fainting, and possibly hospitalization.
Another serious side effect linked to Zelnorm is ischemic colitis, which is a condition resulting from a decreased blood flow to the intestines. This reduced blood flow can cause intestinal damage and, in some cases, death. The signs of ischemic colitis include fever, vomiting, new or worsening abdominal pain, bloody diarrhea, or low back pain. In most cases, ischemic colitis is mild and resolves itself, but some cases can be severe, leading to serious complications and surgery.
On March 30, 2007, Novartis Pharmaceuticals announced that they will no longer sell or market Zelnorm in the United States per a request by the FDA. This request was made after recent clinical trials found a link between Zelnorm and an increased risk of serious cardiovascular events, including heart attacks, strokes, and unstable angina (chest pain that can progress to a heart attack). These events occurred mostly in patients who had prior cardiovascular disease or increased risk factors for cardiovascular disease.
The data was compiled from 29 clinical trials conducted by Novartis Pharmaceuticals to assess the risks and benefits of prescribing Zelnorm for a variety of gastrointestinal ailments. The data from all of the individual trials were combined to assess the amount of risk to the heart and blood vessels from taking normally prescribed amounts of Zelnorm. The research found that, although the number of adverse cardiovascular events occurring was small, the percentage was much higher in the patients taking Zelnorm compared to the patients taking a placebo. Based on this newly available information, the FDA concluded that the overall risks for the drug outweighed the benefits and requested that Novartis Pharmaceuticals discontinue their promotion and sale of the medication pending further discussions with the FDA.
Do I have a Zelnorm Lawsuit?
The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Zelnorm lawsuits. We are handling individual litigation nationwide and currently accepting new Zelnorm cases in all 50 states.
If you or a loved one have taken Zelnorm and suffered a serious cardiovascular side effect, you should contact us immediately. You may be entitled to compensation and we can help.