Novartis is complying with the FDA’s request to suspend U.S. sales of Zelnorm, its irritable bowel syndrome medication. The FDA made the request after new safety analysis data showed a possible link between Zelnorm and incidents of stroke and heart attacks.
The drug was approved by the FDA in 2002. Reviewed data shows, 0.11% of the patients taking Zelnorm experienced unusually cardiovascular episodes, compared with 0.01% of patients treated using a placebo (sugar pill).
“Although we have complied with FDA’s request and are collaborating with the agency, we continue to believe that Zelnorm provides important benefits for appropriate patients,” says Stephen Cunningham, head of U.S. clinical development and medical affairs at Novartis.
Denise Anderson, head of the health care practice at Zurich-based Landsbanki Kepler, says the impact of the removal may be significant. “The company had highlighted that the drug had blockbuster potential,” she notes, adding that analysts had expected Zelnorm to hit $1 billion in sales by 2011. Novartis’ sales of Zelnorm last year were $488 million in the U.S. and $73 million in the rest of the world.