The U.S. Food and Drug Administration (FDA) has requested the suspension of marketing of Zelnorm in the U.S. pending further investigation of the drug.
Zelnorm has been manufactured by Novartis and marketed in the U.S. for the treatment of irritable bowel syndrome with constipation. In recent analysis of data from clinical trials it has been discovered that a small but significant link exists between the use of this drug and serious cardiovascular ischemic events.
These events include unstable angina, heart attack and stroke. They primarily occurred in patients with prior history of such cardiovascular disease and events or those with risk for cardiovascular events.
Patients taking Zelnorm should speak with their prescribing health care practitioner about alternative options at this point.
Novartis will refund out-of-pocket costs to patients for any unused and unexpired Zelnorm tablets returned. For more information about how to return tablets for refunds, contact the Novartis Customer Interaction Center at 888-669-6682.
Novartis states on their web site that they still believe this drug is quite beneficial to patients with irritable bowel syndrome with constipation and they will work with the FDA to find a way to continue to manufacture and market the drug safely.
Pending further investigations from the FDA, all patients who are currently taking Zelnorm should consult with their health care practitioners and discontinue taking the medication. If they experience any cardiovascular events they should seek medical attention immediately and state thet they have been taking Zelnorm.
March 30,2007 resource: Novartis
copyright 2007 Kathy Quan, all rights reserved
