Advisors Recommend Zelnorm for Constipation
But Expert Panel Would Limit Drug to Women Under Age 65
Editor's Note: In March 2007 the FDA asked Novartis -- the maker of Zelnorm -- to pull the drug from the market because of evidence that it raises the risk of heart attacks and stroke. But in July 2007 the FDA ruled that Zelnorm may be used by some patients in critical need of the drug who do not have heart problems.
July 15, 2004 -- An expert panel has backed expanded use of the anticonstipation drug Zelnorm. But they're calling for far tighter restrictions than its manufacturer had requested.
Advisors also voted for stricter safety warnings for existing uses of Zelnorm amid concerns that it can lead to a dangerous form of intestinal disease called ischemic colitis.
Advisors voted 10 to 3 to approve Zelnorm for the treatment for chronic constipation with no identifiable cause -- fewer than three bowel movements per week. But every expert voted for approval on the stipulation that the drug be used only in women and not in men or people aged 65 and over.
That was a far more restrictive approval than Novartis, the drug's manufacturer had sought. The company was asking FDA to approve Zelnorm to treat chronic constipation in men and women of all ages.
"This shouldn't be used in the elderly and that needs to be made loud and clear," says Brian L. Stom, MD, an epidemiologist from the University of Pennsylvania School of Medicine and a member of FDA's Gastrointestinal Drugs Advisory Committee.
The FDA usually follows the recommendations of its expert panels.
The drug was approved in August 2002 to treat women with constipation caused by irritable bowel syndrome. Until April, FDA had received 20 reports linking it to development of ischemic colitis, a dangerous disorder in which blood supply to the intestine is cut off or severely restricted. Thirteen of those cases required hospitalization and there was one death, FDA officials say.
The FDA has not established that Zelnorm directly caused the ischemic colitis cases, but officials note that many of the patients showed no signs or risk factors for the disease before taking the drug.