April 2, 2007

 

 

Dear Patient:

 

 

On March 30, 2007 Novartis announced that it is complying with an FDA request to suspend marketing of Zelnorm.

 

A recent analysis of clinical trial data identified a small imbalance that was statistically significant in the number of cardiovascular ischemic events in patients taking Zelnorm.  These events included heart attack, stroke, and unstable angina.  They occurred primarily in patients who had pre-existing cardiovascular disease and/or cardiovascular risk factors.  There is no demonstrated causal relationship between Zelnorm and these events. 

 

Patients who are taking Zelnorm should stop taking the medication.  Patients can return any unused and unexpired Zelnorm tablets to Novartis for reimbursement of out-of-pocket costs.  More information can be obtained by calling the Novartis Customer Interaction Center at 888-NOW-NOVA (888-669-6682).

 

Novartis believes that Zelnorm provides important benefits for appropriate patients with irritable bowel syndrome with constipation.  We will discuss with the FDA the best way to continue to make this medication available to patients. 

 

Frequently Asked Questions:

 

I HAVE BEEN USING ZELNORM, SHOULD I BE CONCERNED ABOUT A CARDIOVASCULAR EVENT?

 

There is no demonstrated causal relationship between Zelnorm and these events.  Please speak with your doctor about any serious cardiovascular events experienced while on any medication.

 

WILL NOVARTIS OFFER A REFUND? 

 

Patients can return any unused and unexpired Zelnorm tablets and Novartis will reimburse them for out-of-pocket costs.  For full details of  how and where to send unused and unexpired product, patients can contact the Novartis Customer Interaction Center at 888-NOW-NOVA (888-669-6682).