Zelnorm By the Numbers
2—Other drugs (Propulsid and Lotronex) for treating IBS are taken off the market in 2000 due to safety concerns.
2—Times the European Medicines Agency turned down Zelnorm due to problems with the drug.
2—Times the Food and Drug Administration has added Zelnorm warnings to the drug’s label.
5–10%—Improvement by women taking Zelnorm to resolve symptoms of IBS, as compared with those getting placebo.
6 mg—Recommended dosage of Zelnorm, twice daily on an empty stomach.
13—Number of patients who experienced serious Zelnorm heart attacks or other cardiovascular problems from the side effects of Zelnorm during Novartis’ clinical trials. The company’s review of this data forced it to withdraw drug from the market in the U.S. and Canada, and may lead to a Zelnorm recall.
29—Studies done by Novartis of Zelnorm patients in 2006. It finds they are eight times more likely than patients on placebo to suffer heart attacks and strokes from side effects of Zelnorm.
44—Patients who developed serious digestive conditions after using Zelnorm (as of 2004). The Zelnorm side effects suffered by these patients included ischemic colitis, intestinal ischemia and severe diarrhea. In some cases, these conditions led to hospitalization, surgery and even death.
55—Countries in which Zelnorm was sold until its recent withdrawal.
2,660—Women who participated in Novartis’ 2004 ZENSAA trial, which purported to show the safety and effectiveness of Zelnorm.
500,000—People taking Zelnorm prior to its withdrawal from the market in March 2007.
2.13 million—Prescriptions written for Zelnorm in 2005.
12 million—Americans, mostly female, who suffer from IBS.
$560 million—Sales of Zelnorm in 2006, up 34% from 2005.
$1 billion—Projected sales of Zelnorm by 2012 before the Zelnorm withdrawal.