ROCKVILLE, Md., March 30 -- The FDA said today that Novartis has halted sales of tegaserod (Zelnorm), its agent for irritable bowel syndrome and constipation, following suggestions of a small increase in ischemic events, including angina and stroke, in those taking the drug.
A pooled analysis of data from 29 placebo-controlled trials identified 13 ischemic events among 11,614 patients treated with tegaserod compared with a single case among 7,013 placebo-treated patients. The rate of ischemic events was 0.11% in the tegaserod patients versus 0.01% in the placebo group, a difference that Novartis said was not statistically significant.
One of the 13 events was fatal versus no ischemic deaths in the placebo patients.
The withdrawal came at the request of the FDA. Novartis disagreed that there was any causal link between the drug and the events. Novartis continues to believe that the drug "provides important benefits for appropriate patients suffering from irritable bowel syndrome with constipation."
The ischemic events came to light after Swiss health authorities asked Novartis to analyze trial results to identify all ischemic events. An earlier analysis found an increased rate of ischemic colitis and the FDA requested that those data be added to the tegaserod label in 2004.
In 2002 the FDA approved tegaserod for treatment of IBS-c in women and in 2004 expanded the indications to include treatment of idiopathic chronic constipation in men and women younger than 65.
No comments:
Post a Comment