Zelnorm

Free Recalled Drugs Case Review

On March 30, 2007, the Swiss Pharmaceutical company Novartis announced that it was suspending all marketing and sales of the drug Zelnorm® due to a request by the Food and Drug Administration.

First approved in 2002, Zelnorm® (tegaserod maleate) is a treatment for irritable bowel syndrome (IBS), an illness that can cause debilitating abdominal pain but is not generally associated with any other abnormal condition. Almost 12 million people in the United States struggle with IBS each year, and it is not unusual for symptoms such as constipation, bloating, and pain to last between five to 10 years. IBS is separated into three categories:

Alternating Stool Patterns (IBS-A)
Constipation-prominent (IBS-C)
Diarrhea-prominent (IBS-D)

Furthermore, IBS can also develop into a condition called post-infectious IBS (IBS-PI), which generally occurs with an acute onset after an infectious illness that includes fever, vomiting, acute diarrhea, and/or a positive stool culture.

Novartis took this extreme action after it conducted a retrospective analysis of information of more than 18,000 patients they had in their database. This action was due to an ongoing review that involved several health organizations as well as the FDA. The recent analysis of the data suggested that there was a statistically significant imbalance of cardiovascular events between patients taking Zelnorm and those taking a placebo. Some of these cardiovascular events included:

Myocardial infarction (heart attack)
Stroke
Unstable angina pectoris (chest pain caused by a lack of blood and oxygen to the heart.)

The data revealed that 13 out of 11,614 patients treated with Zelnorm/Zelmac suffered potentially fatal heart incidents as compared to one out of 7,031 people treated with placebos. The FDA asked that Novartis suspend their marketing and sales of Zelnorm in order that public discussion as well as an FDA Advisory Committee meeting can reevaluate the risk/benefit profile of this drug.

If you or someone you love was affected by the side effects of Zelnorm, you must consult an aggressive and experience defective drug attorney immediately. You may be entitled to compensation for your pain and suffering, but if you hesitate the statute of limitations in your state could end your case before it has a chance to begin. Do not let your chance for justice pass you by. Contact us today.

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