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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.

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.

Reimbursement Policy for Zelnorm Patients:

Novartis will reimburse Zelnorm patients for their out of pocket prescription costs for unused/unexpired Zelnorm tablets that were purchases within the United States and Puerto Rico.

Patients should call 888-NOW-NOVA (888-669-6682) to obtain the Zelnorm Consumer Product Return Form and a postage paid envelope to avoid incurring any mailing costs.

Patients must return unused/unexpired tablets that were purchased within the United States or Puerto Rico with their prescription receipt by September 30, 2007, in order to qualify for reimbursement. They will receive reimbursement within 6-8 weeks once all information is received.

Frequently Asked Questions About Reimbursement:

What documentation is required and where should patients send it with their unused Zelnorm to receive reimbursement?
	The following documentation is required to be eligible for reimbursement: Zelnorm Consumer Product Return Form completed by the patient Original prescription receipt from the Pharmacy - photocopies will not be accepted Unused/unexpired Zelnorm tablets that were purchased within the United States and Puerto Rico Patients should call 888-NOW-NOVA (888-669-6682) to obtain the Zelnorm Consumer Product Return Form and a postage paid envelope to avoid incurring any mailing costs.
What should a patient do if they no longer have their pharmacy receipt?
	Patients should contact their pharmacist to get a new receipt or a printout of their most recent prescription history.
How long will it take for patients to receive their refund?
	Once all information is received, patients will receive reimbursement within 6 to 8 weeks for their out of pocket cost for the Zelnorm tablets returned to Novartis.
How many days worth of unused medication can the patient submit for reimbursement?
	Patients may return all unused/unexpired Zelnorm tablets in their possession that were purchased within the United States and Puerto Rico. They need to include the pharmacy receipt and the completed Zelnorm Consumer Product Return Form in order to receive reimbursement.
How much will patients be reimbursed?
	The amount will be calculated based on their out of pocket cost and the number of tablets returned to Novartis.

Other Frequently Asked Questions:

Information for Health Care Providers:

Click here for the Dear Doctor Letter

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