Zelnorm Recall
Zelnorm Statistics
2—Times Zelnorm was rejected by the European Medicines Agency.
2—Other drugs (Lotronex and Propulsid) for the treatment of irritable bowel syndrome were withdrawn from the market in 2000 because of safety concerns.
2—Times Zelnorm’s label has been changed to include warnings by the Food and Drug Administration about Zelnorm side effects.
6%—Percentage of patients who reported improvements in their IBS symptoms after taking Zelnorm during clinical trials, compared with those who were given a placebo.
13—Patients who suffered serious cardiovascular Zelnorm side effects, such as heart attack or stroke, during Novartis’ clinical trials. After a review of this data, the company was forced to issue a Zelnorm withdrawal in U.S. and Canadian markets.
29—Studies of Zelnorm patients conducted by Novartis in 2006. The studies found that patients were eight times more likely to suffer Zelnorm heart attacks and strokes than those who were given a placebo.
44—Patients who, between 2004 and 2007, suffered serious digestive problems after using Zelnorm. Their Zelnorm side effects included intestinal ischemia, ischemic colitis and severe diarrhea. Some patients were hospitalized, some underwent surgery and some died.
52—Countries in which Zelnorm is still being sold, its recent departure from the U.S. and Canadian markets notwithstanding.
18,000-plus—Number of patients in the aforementioned 29 clinical studies whose medical data showed the risks of Zelnorm.
500,000—People who took Zelnorm before it was pulled from the market in March 2007.
2 million-plus—Zelnorm prescriptions written in 2005.
12 million—Americans who suffer from some form of irritable bowel syndrome. The majority of these patients are women.
$560 million—Zelnorm’s sales in 2006, a 34% jump from 2005.
