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More Information on valdecoxib (Bextra)

More Information on Celecoxib (Celebrex)

Valdecoxib (Bextra) Ban a Good Step, But FDA Should Pull Celecoxib (Celebrex) Too

April 7, 2005

Statement of Sidney M. Wolfe, M.D., Director, Public Citizen's Health Research Group

In January, Public Citizen petitioned to have Bextra and Celebrex, two COX-2 inhibitors, removed from the market because they increase the risk of heart attacks. Today, the U.S. Food and Drug Administration (FDA) has called on Pfizer to pull Bextra from the shelves and place a warning on Celebrex.

While we are pleased that the FDA has taken Bextra off the market, it has recklessly allowed Celebrex to continue to be sold. An unpublished study finished in 2000 indicated increased cardiac risks associated with Celebrex.

Last year, almost twice as many prescriptions were written for Celebrex as for Bextra — 23.9 million prescriptions compared to 12.9 million. Neither Bextra nor Celebrex protects the gastrointestinal tract as drugmakers claim. Given that neither drug has any unique benefits but both carry unique cardiac risks, it is unconscionable to leave Celebrex on the market.

In addition, the FDA is sowing dangerous confusion by requiring all nonsteroidal anti-inflammatory drugs (NSAIDs) — Celebrex and all non-aspirin NSAIDs — to warn about increased cardiac risks, even though the risks of Celebrex are clearly higher than at least one NSAID, naproxen.

The FDA said today that it took its actions "based on the available scientific data, including data accumulated since the drugs were approved." But the agency's job is to ensure that drugs with risks that outweigh the benefits are taken off the market. We call on Congress, which is finally delving into FDA's operations, to investigate why the agency is not also pulling the equally dangerous Celebrex from the shelves.

Note: Bextra is the tenth prescription drug to be taken off the market in the past seven years that Public Citizen had previously warned consumers not to use. For four of the drugs — Vioxx, Baycol, Rezulin and Serzone — Public Citizen issued warnings more than two years before their removal from the market. In April 2001, Public Citizen warned patients not to use Celebrex. Public Citizen maintains a comprehensive prescription drug database at

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