Novartis suspends Zelnorm sales

With data drawn from recent pooled clinical trials suggesting the occurrence of numerical imbalance in cardiovascular events in patients taking the drug in comparison to those taking a placebo, Novartis has announced that the suspension of the marketing and sales of Zelnorm throughout the US.

The initiative comes following a request from the Food and Drug Administration (FDA) to take the drug off the market after the pharmaceutical firm advised it of the retrospective analysis of its trials, which involved in excess of 18,000 patients.

According to the data, such cardiovascular events occurred in 13 of the 11,614 patients receiving Zelnorm, equivalent to 0.11 per cent of all cases, in comparison to just one occurrence in the 7,031 patients that were treated with a placebo, a rate of 0.01 per cent.

Despite such findings, Novartis are confident that the drug, administered as a treatment for irritable bowel syndrome (IBS) with constipation and chronic constipation is still effective and safe, with the rate of cardiovascular events seen in the recent trials the expected rates for such events within the general population.

“Zelnorm/Zelmac provides unique benefits to patients by treating the multiple symptoms of abdominal pain, bloating and constipation that are associated with IBS with constipation,” said James Shannon, MD, the global head of development at Novartis Pharma AG.

“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.”