July 27, 2007FDA to allow Zelnorm sales to limited group of patients
The Food and Drug Administration has announced that it will allow the irritable bowel syndrome drug Zelnorm to be prescribed to some patients under new tightened restrictions. Zelnorm was pulled from the market in March 2007 after several studies linked the drug to an increased risk of heart attack, stroke and chest pain.
According to the FDA’s announcement, under the new treatment guidelines Zelnorm can only be prescribed to patients who are unable to get relief for their IBS symptoms with other treatments, or who had previously seen improvement with their symptoms with Zelnorm. Only patients who are under 55 years old and who have no known or pre-existing heart problems will be allowed to be prescribed Zelnorm.
Novartis, the drug’s manufacturer, issued a Zelnorm recall in March 2007 after the results of 29 studies showed that patients taking the drug were up to eight times more likely to experience a heart attack, stroke or unstable angina (heart/chest pain).
Although doctors were uncertain why Zelnorm seemed to increase the risk of cardiovascular side effects, some experts believed that the same mechanism which helps to treat the symptoms of IBS may also affect the arteries, leading to an increased risk of cardiovascular problems.