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January 31, 2005
Public Citizen filed a petition urging the U.S. Food and Drug Administration to pull Pfizer Inc.'s arthritis drugs Celebrex and Bextra from the market because of links to deadly cardiovascular events one week ago. Now the group accused Pfizer of burying a study suggesting Celebrex increases the risk of heart attack and stroke.
According to Sidney Wolfe, director of Public Citizen's Health Research Group, "there is no excuse for this study not being made more public." The study tested Celebrex as a treatment for Alzheimer's disease, but found 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. Pfizer has continued to stand by the safety of both Celebrex and Bextra but agreed to stop advertising Celebrex in December after the FDA requested it. The FDA warned doctors in December to limit Celebrex and Bextra prescriptions after continued safety concerns were raised.
The FDA had no comment on Public Citizen's latest study added to its petition for the drugs' withdrawal, but has said it is reviewing the case.
For more information on the Celebrex ban, please contact us to confer with a Celebrex Lawyer and learn your legal rights and options.