The COX-2 inhibitor class of drugs has come under the cosh again, this time from influential US consumer group, Public Citizen, which has formally petitioned for the immediate market removal of Pfizer’s Celebrex (celecoxib) and Bextra (valdecoxib), and urged the US Food and Drug Administration to shelve plans to approve the new offerings currently waiting in the wings – namely Novartis’ Prexige (lumiracoxib) [[24/09/03a]], and Merck & Co’s Arcoxia (etoricoxib) [[01/11/04a]].

In a petition filed with the agency, Public Citizen said that Celebrex and Bextra should be withdrawn because the risk of suffering a heart attack or stroke outweighs their treatment benefits. “If a drug offers no unique benefit compared to other drugs for treating the same problem (in this case arthritis and pain) but subjects patients to a unique risk, it must be removed from the market,” says the 12-page petition. “These drugs are not only more expensive and more dangerous than older, safer pain relievers, they are no better at protecting the gastrointestinal tract,” said Sidney Wolfe, director of Public Citizen’s health research group. Late last year, data from a long-term cancer clinical trial linked Celebrex with an increased risk of heart attack [[20/12/04a]],

Public Citizen also urged the agency not to give the green light to Prexige or Arcoxia. The organisation says it has examined the results of 14 clinical trials, as well as other scientific information, which show that these drugs exhibit the same cardiovascular toxicity as Celebrex, Bextra and Merck’s Vioxx (rofecoxib), which was withdrawn from the market after trial data showed twice the increased risk of heart attack amongst those taking Vioxx, versus placebo [[01/10/04a]].

Although the FDA remained silent about the petition, the agency is planning a public meeting towards the middle of next month to assess the safety of the COX-2 class of drugs and determine whether additional regulatory action is needed [[20/10/04c]].