Influential US consumer group, Public Citizen, has renewed its calls for Pfizer’s Celebrex (celecoxib) pain-killer to be withdrawn from the market, saying that an unpublished study from the US behemoth highlighted a potential increased risk of suffering a heart attack five years ago, according to the Financial Times.
Last week, Public Citizen petitioned the US Food and Drug Administration to pull Celebrex and Pfizer’s other COX-2 inhibitor, Bextra (valdecoxib), from the market, claiming the risks associated with using the drugs outweighs their treatment benefits [[25/01/05b]]. The Financial Times now reports that Public Citizen is highlighting a Phase II Alzheimer’s disease trial conducted in 1999, which showed "a significantly increased rate, 3.6 fold, of serious cardiovascular adverse events.” However, it adds that Pfizer claimed to have filed the data with the FDA in June 2001 and presented the findings at a scientific meeting.
The news comes just one day after US health maintenance organisation, Kaiser Permanente, ordered its pharmacies to stop dispensing Bextra because of a potentially increased risk of heart attack [[31/01/05c]]. The FDA is set to convene an advisory committee meeting later this month to assess the potential risks of the COX-2 inhibitor class as a whole, which was thrust into the spotlight last year after Merck & Co withdrew Vioxx (rofexocib) after trial data linked it to an increased risk of heart attack and stroke [[01/10/04a]], [[20/10/04c]]. The European regulatory authorities are also in the midst of a series of meetings to review the drugs’ safety [[21/01/05b]].