Zelnorm Sales Halted on Heart Events

Mar 30, 03:25 PM

Current Headlines: The U.S. Food and Drug Administration has asked Swiss firm Novartis to suspend sales of its bowel drug Zelnorm, the company said Friday.

The decision came after Novartis notified the agency about a retrospective analysis of data from more than 18,000 clinical trial patients.

Those data showed an increase in the rate of cardiovascular events including heart attack, stroke and unstable angina pectoris in patients taking Zelnorm, compared to those on placebo.

The analysis revealed the Zelnorm-treated patients experienced the heart events at an incidence of 13 out of 11,614 patients, compared to one case in 7,031 in the placebo-treated group, Novartis said.

The company said all of the patients affected had underlying heart disease or heart risk factors.

A small, but not statistically significant increase in the rate of angina pectoris in the Zelnorm patients was first noted in 2002 when the drug was approved, the firm said.

Novartis said it would suspend Zelnorm sales until an FDA advisory panel can meet to determine the product's fate.