Did the FDA require the recall of Vioxx?
No, Merck made this decision independent of input from the FDA. The Agency has not had an opportunity to review the data from the study that was stopped in the depth that Merck has, but agrees with the company that there appear to be significant safety concerns for patients, particularly those taking the drug chronically. The FDA plans to work closely with Merck to coordinate the withdrawal of this product from the U.S. market.
