April 2, 2008Zelnorm sales restricted “only for emergency use”
The manufacturer of Zelnorm has announced that it will only make the drug available to patients in emergency situations with the approval of the Food and Drug Administration. Novartis Pharmaceuticals agreed to stop marketing Zelnorm in March 2007 after it was linked to an increased risk of heart attack, stroke and chest pain. The company was later allowed by the FDA to provide the drug to a limited number of patients.The decision to take Zelnorm off the market was made after 29 studies conducted by Novartis found that patients taking the drug experienced heart problems at a rate that was nearly eight times as high as those who were given a placebo. Although Novartis was forced to stop marketing Zelnorm by the FDA, the agency said that the recent decision to further restrict the sale of Zelnorm was made voluntarily by the company.
Under the new rules, Zelnorm will only be made available with FDA approval to patients in a life-threatening situation or ones that may require hospitalization. However, the FDA may deny approval to patients with certain conditions, including a history of heart attack or stroke, hypertension, diabetes, obesity, age greater than 55 years or other factors that may increase the risk of Zelnorm side effects.
The FDA advises patients who feel they may qualify for emergency use of Zelnorm to speak with their physicians to learn if they may qualify. Doctors seeking approval of emergency use for their patients are advised to contact the FDA’s Division for Drug Information.