What is the evidence that prompted withdrawal of Redux?
On July 8, 1997, the Mayo Clinic reported 24 patients developed heart valve disease after taking Redux. In five patients who underwent valve replacement surgery, the diseased valves were found to have distinctive features similar to those seen in carcinoid syndrome. The cluster of unusual cases of valve disease in Redux users suggested that there might be an association between Redux use and valve disease. On July 8, 1997, the FDA issued a Public Health Advisory that described the Mayo findings. The FDA has since received thousands of reports (including the original 24 Mayo cases) of heart valve disease associated with Redux. Based on these data, American Home Products Corporation agreed to withdraw the product from the market.
