Zelnorm (generically named tegaserod maleate) is a drug medically prescribed to treat severe cases of irritable bowel syndrome (IBS). IBS is a common intestinal disorder estimated to affect 15% of the population. With IBS, the muscles and nerves that control the intestine fail to work properly, causing discomfort and pain in the people who have the disorder. Currently, Zelnorm is the only medication ever approved by the US Food and Drug Administration (FDA) to treat IBS. It is manufactured by Novartis Pharmaceuticals and has been available to the public since 2002.
Zelnorm increases the activity of serotonin in the intestines, which speeds the movement of stools through the bowels. This helps reduce the pain and discomfort of IBS by relieving constipation and reducing the pain and pressure associated with having full bowels. Zelnorm is not considered a cure for IBS and is not effective in all cases.
Common side effects noted during Zelnorm use are dizziness, headache, back or joint pain, nausea, abdominal pain, and excessive flatulence. Diarrhea normally occurs during the first week of treatment, gradually disappearing as treatment continues. A more serious side effect associated with Zelnorm is ischemic colitis, which is a condition resulting from reduced blood flow to the intestines, causing intestinal damage and severe complications.
On March 30, 2007, Novartis Pharmaceuticals made an announcement that they will discontinue the sale and marketing of Zelnorm in the United States, per a request by the FDA. The medication is being removed from the market due to new information regarding the increased risk of adverse cardiovascular events, such as myocardial infarction, cerebrovascular accidents, and unstable angina. Myocardial infarctions, commonly known as heart attacks, occur when the blood supply to a portion of the heart is interrupted. The resulting lack of oxygen causes damage to the heart tissue and can cause the affect heart tissue to die. A heart attack is considered a medical emergency and is considered the leading cause of death for both men and women.
Angina is basically chest pain caused by a lack of blood and/or oxygen in the muscles of the heart. Angina attacks that get worse as the attack progesses, angina that sufaces suddenly while you are resting, and angina lasting for longer than 15 minutes are all considered symptoms of unstable angina. Unstable angina attacks can be an early warning for a heart attack and require urgent medical attention.
A cerebrovascular accident, also known as a stroke, is a neurological injury in which the blood supply to a portion of the brain is interrupted, causing brain cells to become severely damaged or die. The loss of brain cells are irreversible and can impair the function of the portion of the brain affected. A stroke is considered a medical emergency, as it can cause permanent neurological damage and death if not treated promptly. Strokes are the third leading cause of death in industrialized nations, such as the United States, causing a death every 3 minutes on average.
Recent clinical trials conducted by Novartis Pharmaceuticals found the link between Zelnorm and an increased risk of these serious cardiovascular events. Although the amount of adverse cardiovascular events occurring was small, the percentage was much higher in the patients taking Zelnorm compared to those treated with a sugar pill they thought was Zelnorm. Based on this new data, the FDA concluded that the risks of taking Zelnorm outweighed the benefits and requested that the manufacturer remove the product from the market.
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.