Swiss drug giant Novartis is faced with class action and individual lawsuits over Zelnorm. It is likely that there could also be a shareholder lawsuit as well. The company reduced the 2007 sales forecast for IBS drug Zelnorm. Sales were halted by the FDA request since it appears that the treatment is linked to a ten-fold increase of risk of heart attacks and strokes.
Zelnorm (tegaserod) maker has said that "we continue to believe that Zelnorm provides important benefits for appropriate patients." Novartis is taking the position that the rate of cardiovascular ischemic events seen in Zelnorm-treated patients in controlled trials "corresponds approximately with the expected rates for such events in the general population," adding that "a small (but not statistically significant) imbalance in cases of angina pectoris" was included in the US label when the drug was approved in 2002.
The FDA however believes the "risk of very serious harm to patients who have this non-life-threatening condition" makes "this action necessary."
Swiss drug giant Novartis is faced with class action and individual lawsuits over Zelnorm. It is likely that there could also be a shareholder lawsuit as well. The company reduced the 2007 sales forecast for IBS drug Zelnorm. Sales were halted by the FDA request since it appears that the treatment is linked to a ten-fold increase of risk of heart attacks and strokes.
