Why was Vioxx recalled and why did the FDA issue a Public Health Advisory?
Merck’s decision to withdraw Vioxx from worldwide markets was based on data from its recent Adenomatous Polyp Prevention on VIOXX (APPROVe) trial. The purpose of the trial was to see if Vioxx (25 mg) was effective in preventing the reappearance of colon polyps in patients. However, the trial had to be stopped early because the data showed that there was an increased risk for serious cardiovascular events (heart attacks and strokes) after the first 18 months of continuous treatment with Vioxx.