On March 30, 2007, the Food and Drug Administration (FDA) asked the Novartis Pharmaceuticals Corporation to voluntarily discontinue the marketing and sales of Zelnorm ® (tegaserod maleate) because of new information that found an increased risk of serious cardiovascular adverse events, including heart attack, chest pain, and stroke, associated with use of this drug. The FDA issued a Public Health Advisory to inform patients about this announcement and to advise them to consult with a physician about alternative medications.
As of March 30, 2007, Zelnorm is no longer available on the market and has been removed from non-preferred status on Cigna's three-tier commercial formulary and 2-tier Medicare formulary. Changes were made at Argus, the pharmacy claims processor, to stop claim processing for Zelnorm prescriptions. Letters were sent to CignaTURE-Rx members currently receiving Zelnorm, informing them of the withdrawal, and advising that they contact their physician. Furthermore, letters were sent to physicians identifying patients for whom they recently prescribed Zelnorm.
More information can be obtained at:
- FDA Drug Information web page at: www.fda.gov/cder
- FDA Drug Information at: 888-INFO-FDA (888-463-6332)
- Novartis Pharmaceuticals at: 888.NOW.NOVA (888.669.6682)