Zelnorm® received FDA approval for the short-term treatment of women with IBS with constipation in the US on July 24, 2002. Zelnorm® also received FDA approval for the treatment of men and women less than 65 years of age with chronic idiopathic constipation in the US on August 20, 2004.
Recently, Novartis has suspended the sales and marketing of Zelnorm® in the United States in compliance to a request from the USFDA following significant data that associated intake of Zelnorm® to incidence of cardiovascular ischemic events, including myocardial infarction, stroke, and unstable angina pectoris.
According to Stephen Cunningham, MD, Vice President and Head of US Clinical Development and Medical Affairs at Novartis Pharmaceuticals Corporation:
"Zelnorm provides unique benefits to patients by treating the multiple symptoms of abdominal pain, bloating and constipation that are associated with IBS with constipation. Although we have complied with the FDA's request and are collaborating with the agency, we continue to believe that Zelnorm provides important benefits for appropriate patients."
Even so, Novartis complied with the product sales and marketing suspension required by the FDA in order for public discussion and Advisory Committee meeting for the determination of the risks and benefits of Zelnorm®.
Patients taking Zelnorm® are advised to consult their physicians. Additional information regarding Zelnorm can be found by calling the Novartis Customer Interaction Center at 888-NOW-NOVA (888-669-6682).
Read the full report (a pdf file).
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