On April 2, 2007 the FDA removed Zelnorm from the market subsequent to analyzing the results of an extensive study of the drug’s performance. The analysis included data gleaned from more than 18,000 patients, most of whom were treated with Zelnorm but some of whom received a placebo. The conclusion was that the benefits of the drug do not outweigh the risks. Those risks include:
- Heart attack
- Ischemic colitis
Since being approved by the FDA in 2002, Zelnorm, manufactured by Swiss drug maker Novartis AG, has been prescribed for women coping with irritable bowel syndrome. The primary symptom is constipation. The drug increases the movement of stools through the bowels. It does not cure irritable bowel syndrome but it has been shown to help the condition in some regards.
Prior to being recalled it was under prescription to about 500,000 people and in 2006 alone the drug generated just under five hundred million dollars in revenues for the company.
If you or someone you know has been taking Zelnorm, we suggest that you follow up with your health care provider to discuss alternative treatment options. If you or a loved one has suffered from the side effects of Zelnorm, contact the Law Offices of Michael A. DeMayo, L.L.P. ® to schedule your free initial consultation.