Public Citizen renews call for Celebrex ban on new info related to CV risks

US consumer group Public Citizen has repeated its earlier demand to the Food and Drug Administration to withdraw drug giant Pfizer's COX-2 inhibitors Bextra (valdecoxib) and Celebrex (celecoxib; Marketletter January 31), following "recently-uncovered" trial results which, the group says, show the drugs elicit a higher risk to cardiovascular health than previously thought.

In a letter to the FDA, Public Citizen's director, Sidney Wolfe, writes: "we have discovered the results of an unpublished randomized placebo-controlled study by Pfizer, finished more than four years ago, that showed a significantly increased rate (3.6-fold) of serious cardiovascular adverse events and more than a doubling in the rate of cardiovascular deaths in people using Celebrex compared to those using a placebo in a study concerning Alzheimer's disease."

He went on to claim that, "despite these older, but previously-undisclosed findings, when Pfizer recently announced the results of an ongoing colon polyp prevention trial that was stopped because of a 2.5-3.4-fold increased risk of fatal or non-fatal major cardiovascular events in patients using celecoxib, Pfizer chief executive Hank McKinnell stated that 'these clinical trial results are new'."