The popular irritable bowel syndrome drug Zelnorm was pulled from the U.S. market last week after a study found a significantly higher incidence of heart attacks and strokes in patients taking the drug.
The withdrawal came soon after a data analysis of over 18,000 patients, which showed that .11 percent of Zelnorm users experienced severe and life-threatening cardiovascular effects compared to .01 percent in the placebo group.
According to U.S. Food and Drug Administration reports, one of the 13 Zelnorm patients who suffered a heart attack or stroke died.
Zelnorm Safety Issues
Prior to the recent recall, Zelnorm—manufactured by Novartis AG—ran into a number of safety problems and was never approved by drug regulatory agencies in Europe.
Furthermore, consumer advocacy group Public Citizen campaigned against the constipation drug’s approval in the U.S.
In 2004, the FDA ordered Novartis to update the safety label on Zelnorm to indicate certain health risks including the side effects of diarrhea and a certain condition in which blood flow to the intestines is decreased.
However, more life-threatening cardiovascular effects of the drug is what eventually got Zelnorm pulled off the market.
If you or someone you love has suffered:
- Heart Attack
- Stroke
- Angina
- Other Zelnorm side effect
Please contact us today to schedule a consultation with a qualified product liability attorney who can inform you of your legal rights and options.
