Last week the Food and Drug Administration asked Novartis, the manufacturer of Zelnorm, to pull the product from the market. Zelnorm is currently marketed to treat irritable bowel syndrome. Data from clinical trials by the manufacturer, however, indicated an increased risk of heart attacks and strokes in patients taking Zelnorm, according to the FDA. In fact, the agency concluded “the benefits of this drug no longer outweighed the risks.” On March 30, 2007, Novartis agreed to withdraw the drug.
Sales of Zelnorm have amounted to hundreds of millions of dollars in each of the last few years. No doubt, part of the popularity of the drug was related to an intense advertising campaign mounted on its behalf by the manufacturer. This once again calls into question whether it is appropriate for drug manufacturers to advertise their products directly to the general public, particularly in the first year or two after their introduction. It is in this period of time that the safety of the drug is more fully evaluated. This is an issue which Congress should more fully explore.
For more information on Zelnorm and other products being evaluated by the FDA