Tegaserod (Zelnorm) For Bowel Disorders
Novartis is suspending the marketing and sales of tegaserod maleate (Zelnorm drug) in the U.S. This medication is indicated for patients with irritable bowel syndrome (IBS) plus constipation and for those with chronic constipation, including symptoms such as abdominal pain and bloating.
When generic tegaserod was approved in 2002, a statistically nonsignificant imbalance in cases of angina pectoris was recorded and included in the U.S. label. A more recent analysis revealed a statistically significant imbalance in the incidence of cardiovascular ischemic events in patients taking the drug compared with those taking placebo. These events included myocardial infarction, stroke, and unstable angina pectoris.
All of the affected patients had preexisting cardiovascular disease or cardiovascular risk factors. Multiple studies do not suggest any constrictive effects of the drug on coronary arteries.
Novartis is meeting with health authorities in other countries where the product is sold to determine the next steps.
