Zelnorm warning

[Guest guest]

Zelnorm, tegaserod maleate, a drug used in the treatment of IBS with

which many of we fibromites suffer has been withdrawn from the market.

Here is the alert.

*O**n 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 ().

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.

here is the address of the press release:

http://www.zelnorm.com/Zelnrom_PR_US_330_Final_12_1007.pdf