Zelnorm (generically known as tegaserod maleate) is a prescription medication used to treat severe cases of irritable bowel syndrome (IBS). It is manufactured by Novartis Pharmaceuticals and was approved by the US Food and Drug Administration (FDA) in 2002. A Zelnorm recall was issued by the manufacturer on March 30, 2007, due to clinical trial results linking Zelnorm to serious adverse cardiovascular events such as myocardial infarctions, commonly known as heart attacks.
What is a Heart Attack?
A heart attack occurs when the blood supply to part of the heart is disrupted. The lack of oxygenated blood damages the heart tissue, even killing the cells of the heart, which do not regenerate. Collagen growths form in place of the dead cells, permanently scarring the heart. Over 1.2 million people every year suffer a heart attack and it is estimated that a person dies of a heart attack in the United States every 65 seconds.
The appearance of heart attack symptoms is often gradual, slowly emerging over several minutes. Chest pain is the most common symptom of a heart attack, described as a tightness or feeling of pressure on the chest. Other classic symptoms include shortness of breath, weakness, nausea, sweating, vomiting, anxiety, and palpitations. One third of heart attacks are silent, without the pain in the chest or any of the other symptoms manifesting.
A heart attack is considered a medical emergency with immediate treatment needed if a heart attack is suspected. These immediate treatments include aspirin, pain relief, oxygen, and glyceryl trinitrate. Further treatments include medications to break up any blood clots that block the blood flow to the heart and/or restoring the blood flow mechanically by either dilatation or bypass surgery. Heart attacks are considered the leading cause of death in both men and women.
The data linking Zelnorm to higher incidences of heart attacks was compiled from 29 individual studies conducted by Novartis Pharmaceuticals. Although the total number of adverse cardiovascular events was small, the percentage of events in patients that were taking Zelnorm was much higher than in the patients taking a placebo. Based on this data, the FDA determined that the risks of taking the medication outweighed the perceived benefits and requested that the manufacturer issue a Zelnorm recall, which was complied with in March of 2007. As a result, Zelnorm will no longer be marketed or sold in the United States pending further discussions between the FDA and Norvartis Pharmaceuticals.
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.