Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Novartis is complying with a request from the Food and Drug Administration to suspend US marketing and sales of Zelnorm, a treatment for irritable bowel syndrome, after people taking the drug experienced an increase in heart attacks and strokes.
Subscribe to our email newsletter
This action has been taken after Novartis notified the FDA about a retrospective analysis of data from more than 18,000 patients in the clinical trial database. The analysis revealed a statistically significant imbalance in the incidence of cardiovascular ischemic events in patients taking the drug compared to those taking placebo. These events included myocardial infarction, stroke, and unstable angina pectoris.
“Although we have complied with the FDA’s request and are collaborating with the agency, we continue to believe that Zelnorm/Zelmac provides important benefits for appropriate patients,” said James Shannon, global head of Development at Novartis Pharma AG.
Nevertheless, Novartis has suspended the marketing, sales and distribution of Zelnorm, so that public discussion and an advisory committee meeting can take place to determine the risks and benefits of this medicine. The FDA said it might consider a re-introduction of the drug if its benefits were demonstrated in a new test.