Zelnorm (generic: tegaserod maleate) is a prescription drug mainly used to treat women with severe irritable bowel syndrome (IBS). It received approval from the US Food and Drug Administration in 2002. Zelnorm was created and marketed by Novartis Pharmaceuticals, which issued a Zelnorm recall on March 30, 2007.
The Zelnorm recall was made after data from recent clinical trials indicated an increased risk of adverse cardiovascular events, such as heart attacks, strokes, and unstable angina pectoris, in patients taking the medication. These events occurred mostly in patients with prior cardiovascular disease or a higher risk factor for cardiovascular disease. Although the number of these events occurring was small, the percentage of people taking Zelnorm affected was significantly higher than in the individuals taking a placebo.
Angina pectoris is the medical term for chest pain caused by a lack of blood and/or oxygen in the heart muscle. The term comes from the Greek word “ankhon” meaning “strangling” and the Latin word “pectus” meaning “chest”. This is most likely due to the fact that someone suffering from this condition describes the pain of an attack as a squeezing sensation, a tightness in the chest, or a feeling of pressure.
In addition to chest discomfort, pain from angina pectoris may also be felt in the upper abdomen, neck, jaw, back, or shoulders. The pain can be accompanied by sweating, breathlessness, or nausea. Angina pectoris attacks usually last for 1 to 5 minutes; pain lasting only a few seconds is normally not angina pectoris. Angina pectoris attacks that worsen as the attack progresses, angina pectoris that occurs suddenly while you are at rest, and angina pectoris lasting longer than 15 minutes are all considered signs of unstable angina. Unstable angina is an indication that an individual has a high risk of having a heart attack, cardiac arrest, and sudden cardiac death.
Based on this new information gleaned from 29 individual clinical trials, the FDA decided to take a closer look at Zelnorm. After their assessment, the FDA came to the conclusion that the risks of taking Zelnorm were greater than the benefits gained from taking the medication. The FDA requested that the manufacturer discontinue the sale and promotion of the drug, which was complied with in March of 2007. A Zelnorm recall was issued and Zelnorm will no longer be sold in the United States pending further discussions with the FDA.
Our Experience - IBS Drug Litigation
Why You Should Choose Schmidt & Clark, LLP
“Our law firm has substantial expertise in the areas of gastrointestinal disorders such as IBS and the medications used to treat them."
Recently, the firm acted as lead counsel in the successful resolution of several hundred consumer claims involving the drug Lotronex® (alosetron), another IBS drug that was taken off the market because of serious side effects such as ischemic colitis (bleeding of the bowel) and bowel obstructions. Lotronex® was used to treat people with diarrhea-predominant IBS, but its pharmacology and mechanism of action is very similar to Zelnorm®. Both drugs act on a neurotransmitter substance called serotonin which effects numerous functions of the body, including “gut motility” (operation of the bowel), but also the brain and cardiovascular system.
Our attorneys are able to draw upon the pool of experience gained in Lotronex® and other products liability litigations to appropriately investigate, evaluate, and pursue potential Zelnorm® claims.
If you or a loved one have taken Zelnorm and suffered a serious cardiovascular or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.
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.
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