NEWS - Public Citizen: Bextra Ban a Good Step, But FDA Should Pull Celebrex Too

[Guest guest]

April 7, 2005

Bextra Ban a Good Step, But FDA Should Pull Celebrex Too

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 An unpublished study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

www.WorstPills.org.

http://www.citizen.org/pressroom/release.cfm?ID=1914

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

[Guest guest]

----- Original Message -----

From:

> How about letting the CONSUMER decide? To me, Celebrex has definite unique

advantages over other NSAIDs. And, I have no heart risk factors.

Choices such as this should be between patient and doctor. I'm sick of people

trying to legislate or use political lobbying to affect my health care choices.

Not with all the lawsuits in this country. Just look at the lawsuits already

over VIOXX. Being able to choose on our own is not going to happen in such a

litigious society.

Nina

[Guest guest]

----- Original Message -----

From:

> How about letting the CONSUMER decide? To me, Celebrex has definite unique

advantages over other NSAIDs. And, I have no heart risk factors.

Choices such as this should be between patient and doctor. I'm sick of people

trying to legislate or use political lobbying to affect my health care choices.

Not with all the lawsuits in this country. Just look at the lawsuits already

over VIOXX. Being able to choose on our own is not going to happen in such a

litigious society.

Nina