PHILADELPHIA LEGAL HELP CENTER - ZELNORM LAWYER

Zelnorm Recall Quick Facts:

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• The FDA cited heart risks in requesting its withdrawal.
• Clinical studies revealed that out of more than 11,000 patients taking Zelnorm, 13 patients suffered heart attacks, chest pain or strokes, and one died.
• ore than 2.6 million prescriptions were written for the medication in 2006, a 25% increase from the previous year.
• Novartis said its sales of the drug approached $490 million in 2006.
• It was approved in the United States in 2002 and ranked among the top 200 brand-name prescriptions last year.
• Zelnorm is prescribed for Irritable bowel syndrome can cause constipation
• Out of 7,000 patients that got the placebo, one had a near stroke.

The Food and Drug Administration said it asked for the withdrawal of Zelnorm after an analysis of 29 studies involving more than 18,000 patients found that those who took the medication had significantly higher rates of cardiac problems than those who were given a sugar pill.

Warning: Patients taking Zelnorm should seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke.

Zelnorm Side Effects Include

• Heart Attack
• Stroke
• Angina Pectoris
• Intestinal Ischemia (rectal bleeding, bloody diarrhea or abdominal pain)
• Serious Chest Pain
• Serious Gastrointestinal Injuries

Previous Zelnorm Problems

Zelnorm has been observed to be linked to ischemic colitis, severe diarrhea, and potential for death in some patients. The FDA has ordered a labeling precaution about the intestinal condition about Zelnorm, along with an order to place larger warnings about severe diarrhea on Zelnorm labels. Zelnorm is used to help movement of stool through the colon.

Twenty-one reports to the FDA of severe diarrhea causing low blood pressure and fainting as side effects. Sixteen Zelnorm patients were reported to have required immediate hospitalization. The FDA received 20 reports of ischemic colitis and three concerning similar intestinal problems. Four patients died and fourteen needed hospitalization.

The FDA has warned that Zelnorm should be discontinued by anyone with frequent diarrhea, and those experiencing dizziness or fainting should stop the drug immediately.

Irritable bowel syndrome (IBS) is an intestinal disorder that gives millions of women and some men, abdominal pain, severe diarrhea, constipation, sometimes both. Zelnorm is the only FDA-approved therapy for the constipation-causing form of IBS. It is usually prescribed only for women.

If you or someone you know has been injured by Zelnorm please contact us for free case evaluation to know your legal rights.