Zelnorm recall

[cat lady]

Zelnorm recall

 

On March 30, 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 speak with their doctor about other appropriate treatment options. 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 adverse events that you experience while on any medication.

SHOULD I STOP TAKING ZELNORM?

 

We advise patients to consult with their physicians and discuss other appropriate treatment options.

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)

WHAT DOES MARKETING SUSPENSION OF ZELNORM MEAN?

 

Novartis will no longer sell or promote Zelnorm in the US pending further discussions with the FDA.

Novartis Press Release:

 

Click here for the March 30th, 2007 Novartis press release.

For more information about Novartis, please visit www.novartis.com

For more information from the FDA, please visit www.fda.gov/cder

[justashell]

Thanks for the heads up Cat---it's always something, isn't it??? Hope you are doing well...