BREAKING NEWS: IBS Agent Tegaserod (Zelnorm) Is Pulled From Market

March 30, 2007

ROCKVILLE, Md. -- The FDA announced today that Novartis has agreed to withdraw Zelnorm (tegaserod), the only approved drug for irritable bowel syndrome (constipation), after a pooled analysis of 29 placebo-controlled, short-term trials found a small but statistically significant increase in ischemic events, including angina and stroke. The analysis identifed 13 such events, including one death, in more than 11,600 patients treated with tegaserod versus one event among a placebo group.

ROCKVILLE, Md., March 30 -- The FDA announced today that Novartis has agreed to withdraw Zelnorm (tegaserod), the only approved drug for irritable bowel syndrome (constipation), after a pooled analysis of 29 placebo-controlled, short-term trials found a small but statistically significant increase in ischemic events, including angina and stroke. The analysis identifed 13 such events, including one death, in more than 11,600 patients treated with tegaserod versus one event among a placebo group.