The Food and Drug Administration (FDA) announced Novartis Pharmaceutical’s cooperation in agreeing to the FDA’s request that they volunatarily discontinue the sales and marketing of their drug Zelnorm (tegaserod maleate).
The request made by the FDA, was based on new safety analysis studies that showed an increased risk of serious cardiovascula adverse events that include heart attack, chest pain and stroke that are associated with taking the drug Zelnorm.
Based on the new information, the FDA determined the overall risk versus the benefit of taking this drug is unfavorable for continued use and marketing.
For some patients there may be no other treatment options available and the benefits of Zelnorm outweight the chance of serious side effects. The FDA will continue to work with Novartis to allow access to Zelnorm for these patients in a special program.