Novartis discontinues Zelnorm (tegaserod) over safety concerns

Novartis voluntarily discontinued Zelnorm, tegaserod maleate, which was used for Irritable Bowel Syndrome and constipation and was in markets since 2002. This decision came after the safety concerns raised by FDA. Recent clinical trial data showed Zelnorm as having an increased risk of cardiovascular adverse events.

The analysis included more than 11,600 patients treated with Zelnorm and over 7000 patients treated with placebo. The data showed that the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm is higher than with placebo treatment.
Thirteen Zelnorm-treated patients (or 0.1%) had confirmed cardiovascular ischemic events, and only 1 placebo-treated patient (or 0.01%) with an event.

Tegaserod is a 5-HT4 receptor partial agonist. Both motor and sensory functions of the gut appear to be altered in patients suffering from irritable bowel syndrome (IBS). Tegaserod, by acting as an agonist at neuronal 5-HT4 receptors, triggers the release of further neurotransmitters. This stimulates the peristaltic reflex and intestinal secretion, as well as inhibits visceral sensitivity.

Tegaserod is available in 55 countries worldwide. In India, several generic brands are available in the market. Emcure’s Irbez, Cipla’s Tegod to name a few.

Seeji, Pharm House.