Following Novartis' suspension of Zelnorm sales and marketing on the United States, the State Food and Drug Administration of China says that it will not force a recall, but instead keep a close watch on the safety of this prescriptive medication.
A recent analysis of clinical trial data identified an 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. Novartis says there is no demonstrated causal relationship between Zelnorm and these events.
Zelnorm is one of the few medications approved to treat Irritable Bowel Syndrome with constipation mainly affecting women, and chronic constipation in adults younger than 65 years of age. China's National Center for ADR Monitoring reported that it has received 98 reports about Zelnorm with the main symptoms being diarrhea, nausea and abdominal pain.
Zelnorm is sold in 55 countries. In China, it has been sold for more than three years and three Chinese pharmaceutical plants of Beijing Novartis, Chongqing Huabang Pharmaceutical Company and Chongqing Yaoyou Pharmaceutical Company are producing the medicine.
Irritable Bowel Syndrome is a mysterious disorder that gives millions of people, mostly women, abdominal pain and either severe diarrhea or severe constipation or both.
