Zelnorm
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Zelnorm
Zelnorm is a drug that was developed and marketed by Novartis Pharmaceuticals. It is a medication for irritable bowel syndrome (IBS), designed to alleviate the bloating, abdominal pain and constipation that is incumbent with the chronic onset of IBS. In 2002, the FDA approved Zelnorm (marketed as Zelmac outside the U.S.) as the first drug to be made available to women with IBS and for whom the primary symptom is constipation. At that time, it had not been approved for use with men.
Acknowledged side effects for Zelnorm include diarrhea – especially when beginning with the medication – as well as dizziness, abdominal pain and cramping. However in March of 2007 the FDA alleged that, based on data collected on 18,000 patients (over 11,500 of whom were Zelnorm users); there was an increased rate of cardiovascular incidents among those using the drug.
The FDA requested that Novartis take Zelnorm off the market. Shortly thereafter, Novartis also took the drug off the Canadian market in response to a similar request. The company’s public stance is that Zelnorm continues to be an effective treatment for some forms of IBS. It further contends that the data analysis leading to the drug’s withdrawal showed a statistically insignificant variation in cardiovascular incidents and that all patients who were impacted had a history of cardiovascular difficulties.
Nevertheless, Zelnorm has enjoyed a relatively brief exposure to public sale in this country. Because of its widespread use, there is the distinct possibility that it may have impacted a number of individuals who were not among those studied prior to the withdrawal order. If you or a family member has ever used Zelnorm and has had subsequent cardiovascular incidents of any sort, give us a call. Our consultation will be thorough, professional and free of cost.
