Re: Ban Celebrex? No. i agree

December 18, 2004

i agree with you i was celeberex years ago . and that was the time i felt the

best i ever had. it was a shame it only lasted 6 mos. until my body rejected it.

( ................. mike

snowdrift52003 <snowdrift52003@...> wrote:

I'm disturbed by the fear frenzy about Celebrex. I think it should

remain available for patients who absolutely cannot stomach other

NSAIDs and have low risk for heart problems. Let the doctors weigh

(and communicate) the risks. A total ban seems excessive at this

point.

Sierra

> Dec. 17, 2004

>

> Public Citizen to Call on FDA to Ban Celebrex and Bextra

>

> Statement of Dr. Sidney Wolfe, Director of Public Citizen's Health

> Research Group

>

> Even before today's announcement by Pfizer about the heart attack

risks

> associated with Celebrex, Public Citizen's Health Research Group was

> preparing a petition to the U.S. Food and Drug Administration (FDA)

to

> ban both Celebrex and the other Pfizer COX-2 drug, Bextra. In

February

> 2001, we testified at an FDA advisory committee hearing that the

cardiac

> risks of Celebrex (and Vioxx) demanded a black box warning for

both

> drugs. Two months later, in the April 2001 issue of our newsletter

Worst

> Pills, Best Pills News (now online at worstpills.org), we urged

patients

> not to use either drug because there are safer alternatives.

>

> Today's announcement by Pfizer is quite misleading because the

company

> states that " These clinical trial results are new. The

cardiovascular

> findings in one of the studies (APC) are unexpected. " Four years

ago,

> after reviewing the results of the Pfizer-funded CLASS study, an FDA

> physician stated that " the incidence of adverse events related to

> cardiac ischemia (decreased blood flow to the heart) was higher in

the

> celecoxib [Celebrex] group ... and was most pronounced in the group

of

> patients not taking ASA (aspirin) " as a cardiovascular protective

drug.

> In these patients, the rate of heart attack was also highest in the

> celecoxib group (0.2 percent) compared with users of the other two

drugs

> (0.1 percent). For all patients, on and off aspirin, there was a

higher

> incidence of atrial fibrillation, a type of heart rhythm

disturbance, in

> the celecoxib group compared to those taking ibuprofen or

diclofenac.

> Again this was more pronounced in the group not taking aspirin. Dr.

> Throckmorton concluded by stating that " the data do not exclude a

less

> apparent pro-thrombotic [blood clot-forming] effect of celecoxib,

> reflected in the relative rates of cardiac adverse events related to

> ischemia. "

>

> Even earlier evidence of the danger of Celebrex was published more

than

> four years ago. In a study in the Aug. 29, 2000, Proceedings of the

> National Academy of Sciences, the ability of rabbits to withstand

> temporary experimental coronary artery occlusion (experimental heart

> attack) was significantly impaired by treatment with celecoxib

> (Celebrex), which completely blocked the cardioprotective effects

of the

> COX-2 enzyme. The authors of that study concluded that COX-2 enzyme

is a

> " cardioprotective protein. " Therefore, it is implied, drugs that

block

> this cardioprotective enzyme, such as COX-2 inhibitors, may

neutralize

> the protective effects of this important enzyme.

>

> The FDA should remove Celebrex and Bextra from the market

immediately.

>

======================================================================

>

> Public Citizen fights for the rights of the individual citizen in

the

> halls of power and leads the battle to strengthen public health,

> safety, and environmental protection. To retain our independence,

> Public Citizen does not accept government or corporate funds. For

more

> information about Public Citizen, visit http://www.citizen.org.

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

December 18, 2004