Zelnorm Recalled Under Pressure from FDA
On March 30, 2007, Novartis, a Swiss pharmaceutical company, announced a recall of its drug Zelnorm after a direct request from the Food and Drug Administration (FDA). Below are details as to why this recall was initiated and why the drug was originally released to the worldwide market. If you have been using the drug Zelnorm or you know someone who is or has used it, the information below is vital both to your health and your legal rights.
Reasons for Recall
The recall was initiated after Novartis performed a statistical analysis of 18,000 users of the drug who were present in its records. This study showed that users of Zelnorm were nearly 10 times as likely to develop serious side effects as a result of using the drug as those who were given a placebo. Specifically, 13 users of the 11,614 studied who used Zelnorm had developed these side effects compared to one user of the 7,031 who were given the placebo.
Side Effects Explained
Generally, these side effects fall under the label of “cardiovascular events,” but specifically, these events involved:
- Myocardial infarction (heart attack)
- Stroke
- Unstable angina pectoris (chest pain caused by a lack of blood and oxygen to the heart.)
Given the seriousness of these side effects, the FDA asked the company to suspend the marketing of Zelnorm until further investigations could be completed due to the potential dangers associated with its use.
Zelnorm History and Uses
Zelnorm was originally approved in 2002 as a treatment for Irritable Bowel Syndrome (IBS), which is a condition that not only causes excruciating pain in those who suffer from it, but it can also last up to 10 years before this pain subsides. IBS can also develop into a condition known as post-infectious IBS (IBS-PI), which generally presents itself in an acute nature in a patient with the following symptoms:
- Fever
- Vomiting
- Acute diarrhea
- Positive stool culture
However, IBS is not generally associated with any other serious medical condition, and therefore is not considered life-threatening by nature. As a result, the recall was seen as the most advisable way to proceed.
Your Rights
Regardless of the precautions being taken, there are still people out there who have suffered as a result of taking Zelnorm. If you or someone you love is one of those people, the first step you need to take is to speak to your doctor immediately to evaluate your medical condition. Your second step should be to contact an experienced attorney to explain your situation. He or she will be able to explain your rights and options to you clearly, and your attorney will also be able to navigate the sometimes-complicated waters of dealing with enormous pharmaceutical companies. Do not hesitate, as you only have a certain amount of time to assert and protect your rights. Contact an attorney today.
Images portrayed in this site are not actual clients. It is not implied that images of people on this
site are real or have had their health harmed or affected from using Zelnorm.
