Novartis Zelnorm for IBS, FDA Recall Warning, Lawyer
Zelnorm
Due to pressure from the Food and Drug Administration, the Swiss pharmaceutical giant Novartis announced on March 30, 2007 that it would suspend all marketing and sales of their popular Irritable Bowel Syndrome (IBS)-treating drug Zelnorm throughout the United States. Recent studies reveal the drug could cause serious and potentially fatal cardiovascular-related side effects.
Irritable Bowel Syndrome is a gastrointestinal condition that affects an estimated 12 million Americans each year. It is split into three main categories distinguished by the characteristics of the condition:
- Alternating Stool Patterns (IBS-A)
- Constipation-prominent (IBS-C)
- Diarrhea-prominent (IBS-D)
There is a fourth type of IBS called post-infectious IBS (IBS-PI). This type usually develops after a person suffers from an infectious illness that causes fever, vomiting, acute diarrhea, and/or a positive stool culture.
The action by Novartis was prompted by an investigation by the FDA and other health authorities over a retrospective analysis of Zelnorm test subject information gathered in 2002. This recent review of the clinical database discovered a statistically significant imbalance of cardiovascular events between patients taking Zelnorm/Zelmac and those taking placebos. These cardiac events include:
- Myocardial infarction (heart attack)
- Stroke
- Unstable angina pectoris (chest pain caused by a lack of blood and oxygen to the heart.)
The data of the studies revealed that that these events occurred in 13 out of 11,614 patients compared to one case out of 7,031 taking placebos. The reason the Food and Drug Administration asked Novartis to halt marketing and sales of Zelnorm in the United States is to give the public time to assimilate this information and for an Advisory Committee to review the risk/benefit profile of the drug. There will likely be further analysis of the safety of Zelnorm as an effective treatment of IBS.
If you or someone you know was the victim of the potentially fatal cardiovascular side effects of Zelnorm you must speak to a defective drug attorney immediately. You may be entitled to seek financial compensation for your pain and suffering, but if you hesitate the statute of limitations in your state may expire and leave you with no legal recourse to collect restitution for your injuries. Let our dedicated, aggressive, and experienced defective drug attorneys fight for you. Contact us today.
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