The U.S. Food and Drug Administration approved Zelnorm® in 2002 for the treatment of irritable bowel syndrome and constipation. Since its release, more than 500,000 Americans have taken the drug. In March 2007, the FDA ordered the manufacturer, Novartis AG, to pull Zelnorm® from the market after reports of life-threatening cardiovascular risks. Zelnorm’s® recall from the U.S. market was prompted by a data analysis of over 18,000 patients that were using the drug. The review found that .11 percent of Zelnorm® users suffered some sort of serious cardiovascular side effect compared to only .01 percent in the placebo group. One patient involved in the study suffered a fatality. Zelnorm® side effect risks include:
- Heart attack
- Angina (pain and tightness in the chest)
- Severe diarrhea
- Decreased blood flow to the intestines
If you have been adversely affected by Zelnorm®, please contact us for a free case evaluation and consultation.