Zelnorm Recall
August 6, 2007FDA will allow Zelnorm only when benefits outweigh the risks
The Food and Drug Administration has announced that it will allow doctors to prescribe the irritable bowel syndrome drug Zelnorm to a limited number of patients only when the benefits of the drug outweigh the risk of cardiovascular problems. The agency had asked the drug’s manufacturer, Novartis Pharmaceutical, to withdraw it from the market in March due to the risk of Zelnorm side effects.After the FDA asked Novartis to conduct an analysis of its clinical trial data for Zelnorm, the company found that patients taking the drug were at an increased risk of heart attack or other cardiovascular problems compared with patients who were given a placebo. There were approximately eight times as many Zelnorm heart attacks or other cardiovascular complications with the drug than in the placebo group.
According to the new FDA guidelines, doctors will be able to prescribe Zelnorm to female patients under the age of 55 who are in critical need of the drug. These patients must also have no history of heart problems and suffer from either constipation or chronic idiopathic constipation in order to qualify for treatment.
Patients for whom the drug’s benefits outweigh the risk of Zelnorm side effects, or who have no other available treatment options, can also be prescribed Zelnorm under the new rules. But despite easing restrictions on the drug, the FDA says that all patients will be required to sign consent forms to ensure that they are properly informed of the danger of Zelnorm side effects.