http://www.medicalnewstoday.com reports that The Food and Drug Administration (FDA) has requested that the New Jersey pharmaceutical company, Novartis, voluntarily discontinue marketing Zelnorm. Recent findings discovered an increased risk of serious heart problems from using Zelnorm. Novartis has agreed to voluntarily suspend marketing of the drug in the United States; it is marketed in 55 countries. What will the other 54 countries do?Zelnorm is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. Zelnorm was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65.
FDA is currently advising patients who are using Zelnorm to contact their healthcare providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke.
In a recent clinical study of 11,600 patients treated with Zelnorm and over 7,000 patients treated with a placebo, data showed that there was a higher risk of serious adverse heart events such as angina, heart attacks, and strokes associated with Zelnorm than with placebo treatment.
