Zelnorm (generic name: tegaserod maleate) is a medication primarily used to treat severe irritable bowel syndrome (IBS) in women. It was created and marketed by Novartis Pharmaceuticals and received approval from the US Food and Drug Administration (FDA) in 2002. The manufacturer issued a Zelnorm recall on March 30, 2007, citing recent clinical data linking Zelnorm to serious cardiovascular events, such as strokes, as a contributing factor.
What is a Stroke?
A stroke, medically known as a cerebrovascular accident, is classified as a neurological injury. In a stroke, the blood flow to a part of the brain is interrupted, causing brain damage or death of the brain cells affected. The loss of brain cells cannot be reversed, which can impair the function of that area of the brain. A stroke is considered a medical emergency. If not treated promptly, it can cause permanent neurologically damage and death. Strokes are the third leading cause of death in industrialized countries, killing an individual every 3 minutes on average. It is also the leading cause of adult disability in the United States.
The symptoms of a stroke vary greatly depending on what part of the brain is affected and how large the affected area is. The more common symptoms of a stroke include muscle weakness, numbness, loss or reduction of sensory perceptions, decreased reflexes, headache, and vomiting. In the majority of cases, the symptoms only affect one side of the body, the opposite side from where the stroke has affected the brain. Some less common symptoms of a stroke include imbalance, vertigo, weakness of the tongue, aphasia, and disorganized thinking.
Having a stroke can affect a patient mentally, emotionally, physically, or any combination of the three. Physical issues resulting from a stroke may include paralysis, inability to perform learned movements, loss of vision, loss of appetite, and difficulties with daily living activities. Emotional issues arising from having a stroke can result from either direct damage to the brain or from frustration at the inability to perform routine tasks. Emotional difficulties that affect post-stroke patients include anxiety and panic attacks, apathy, mania, psychosis, and flat affect, the inability to express emotions. Mental issues that can result from a stroke include speech problems, dementia, perceptual disorders, and attention and memory problems. The results of a stroke can vary greatly depending on the size and location of the area affected. If the stroke is severe, coma and/or death can occur.
The data linking Zelnorm to an increased risk of having a stroke was compiled from 29 individual clinical trials conducted by Novartis Pharmaceuticals. Although the amount of adverse events were small, the percentage occurring in patients taking Zelnorm was much higher than in patients taking a sugar pill they thought was Zelnorm. Based on this new information, the FDA reached the conclusion that the risks of taking Zelnorm was too high compared to the benefits associated with taking the medication, and requested that the manufacturer refrain from marketing and selling Zelnorm in the United States.
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.