Celebrex News
US group says Pfizer hid Celebrex heart-link study
-Reuters Health
01/31/2005 - A U.S. consumer group on Monday accused Pfizer Inc. of burying a study suggesting its painkiller Celebrex boosts the risk of heart attack and stroke, the group's latest salvo in a bid to ban all drugs in the class.
The accusation comes a week after the group, Public Citizen, filed a petition urging U.S. Food and Drug Administration to pull Pfizer's arthritis drugs Celebrex and Bextra from the market because of links to dangerous heart complications.
The study in question, which tested Celebrex as a treatment for Alzheimer's disease, found that patients taking Celebrex had a 3.6 times greater occurrence of a serious heart event compared to those on placebo, according to a Public Citizen analysis of the data.
The trial took place from 1997 to 1999, according to a summary of it on the Web site clinicalstudyresults.org, which includes study results provided by drug makers.
Public Citizen accused Pfizer of trying to hide the study, because when the company in December revealed that Celebrex more than doubled heart attack risk in a large cancer-prevention trial it described the results as new.
"There is no excuse for this study not being made more public," said Sidney Wolfe, director the health unit at Public Citizen, which wrote the FDA on Monday, adding the study to its petition for the drugs' withdrawal.
Pfizer officials did not return repeated calls for comment.
Celebrex and Bextra are part of a class of drugs called Cox-2 inhibitors that have come under scrutiny since Merck & Co. in September recalled its painkiller Vioxx after a study showed it doubled the risk of heart attack and stroke.
The FDA had no comment on the latest Public Citizen submission, but has said it is reviewing the case.
The FDA warned doctors in December to limit prescription of Celebrex and Bextra, in light of evidence they may raise the risk of serious heart complications.
Pfizer, which has steadfastly supported the safety of the two drugs, agreed to stop advertising Celebrex as the FDA investigates the class.
The Cox-2 drugs were marketed as a safer alternative to older non-steroidal, anti-inflammatory painkillers, known as NSAIDs, such as Advil, which can be hard on the stomach.
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