Pfizer working on Bextra’s return to market

April 22, 2005

By CHRIS DATOL

With the recent pullout of the COX-2 painkiller Bextra (generic name

valdecoxib) by the Bureau of Food and Drugs (BFAD), Pfizer, Inc.

insisted it will still work on having their product, along with its

injectable prodrug Dynastat (parecoxib) re-introduced to the market in

the near future, " considering the benefits that these products offer to

patients. "

The US Food and Drug Administration (FDA) has ordered Pfizer, Inc., to

suspend sales of the drug in the United States, Canada and Europe last

April 7, citing potential risks of cardiovascular problems and

" life-threatening skin reactions. "

An advisory from BFAD Director Barbara Guttierez meanwhile

imposed the pullout in the local market last April 12, noting that

Bextra and Dynastat posed a risk of rare but life-threatening skin

reactions like Erythema Multiformae, s ’s Syndrome (SJS)

and Toxic Epidermal Necrolysis (TEN).

Low dosage is okay

Pfizer earlier attempted to defer the suspension of the drug in the

Philippines, saying it " disagrees with FDA’s position regarding the

overall risk/benefit profile of valdecoxib. "

The company emphasized it agreed to withdraw the drug even though its

cardiovascular risk " could not be differentiated " from that of other

painkillers.

Pfizer’s Medical Director Dr. Leachon explained that the local

dosage of Bextra for arthritis, pain and other acute conditions is more

acceptable and does not pose serious risks as the high-dosage

prescription for chronic illnesses in the US and Europe which led to

the pullout.

" We were caught by surprise with the BFAD’s decision because they

pointed out the rare skin reactions as the cause of the suspension. But

as we explained to them, these reactions are already described in

Bextra’s label, and are known to be caused by other drugs as well, " he

said.

" Doctors right now are at a loss because they have found these

medications to be reliable options for the treatment of pain. We intend

to explore ways with BFAD under which this could be made possible, " Dr.

Leachon added.

Pfizer reported sales of $1.3 billion for Bextra last year.

Celebrex reaffirmed

Bextra is the second painkiller to be withdrawn from the market after

Merck’s Vioxx, which was voluntarily pulled out by its drugmaker in

September last year. The COX-2 drugs, including Pfizer’s Celebrex, are

widely prescribed for arthritis and severe pain but have all come under

fire recently for being linked to a higher incidence of cardiac

problems in some patients.

Celebrex however remains in the market after the FDA reaffirmed the use

of celecoxib capsules for the treatment of pain and inflammation of

rheumatoid arthritis and osteoarthritis.

Pullout in Asia

After a meeting with Dr. Leachon and experts from medical associations

in the country last April 11, BFAD decided to abide by the FDA decision

and ordered the pullout of Bextra from the local market effective April

12.

Meanwhile, a day after the FDA announced its ruling (April 7), BFAD’s

counterparts in Asian countries like Singapore and Malaysia already

called for Bextra’s withdrawal in their respective markets.

Black box warnings

US health officials have also ordered new warning labels for a similar

class of drugs, including Pfizer’s Celebrex.

Both the FDA and BFAD have asked all pharmaceutical companies to: Have

black boxed warnings regarding heart problems and stomach bleedings on

all prescription NSAIDs; revise product labels for all OTC NSAIDs,

except aspirin; give additional information side effects; and to

develop labels/posters for OTC NSAIDs warning the public about

potential adverse skin reactions.

" For now, patients should stop taking Bextra and contact their

physicians about appropriate treatment options, " Pfizer said.

(With additional reports from Reuters, Deutsche Presse Agencie and

Associated Press.)

http://www.mb.com.ph/HLTH2005041832793.html

April 22, 2005

I hope they do get it back on the market, then I can switch from

Celebrex back to Bextra. The Celebrex seems to be working pretty well

for me, but after starting it, I noticed that my blood glucose readings

are higher than usual. I hadn't changed my eating habits or exercise

routine or anything to cause higher readings.

So I looked up the side effects of Celebrex, and there among the rare

ones are listed diabetes and hyperglycemia. Leave it to me to get rare

side effects. Like, Arava increased my cholesterol, and that was listed

as a rare side effect.

I don't know if it's the Celebrex that's raising my BG's or not, but

it's the only thing that's changed for me. My diabetes has been very

well controlled, and I don't want some medication messing it all up. My

prescription is for two 100 mg tablets a day. Because of this possible

side effect, I've just been taking the morning tablet. Sue

On Friday, April 22, 2005, at 10:41 AM, a wrote:

>

> Pfizer working on Bextra’s return to market

>

April 28, 2005

I received a letter from my insurance company telling me to inform my

dr. that is was taken off the market. Well, DUH!! Didn't matter, I

took myself off it and told my rheumy so. When I told him all the

problems I was having with it, he finally agreed with me. That was in

January. Funny I complained before (about a year ago) and he shrugged

it off, but put me on Celebrex again. Had a really bad flare and he put

me back on Bextra even after reminding him of the side effects I was

having. I'm not sure why the insurance company sent me the letter

unless I still have a Rx for Bextra. Does it matter? I don't think the

pharmacy can get it any more. Whatever, for me I am glad the government

finally took action and didn't listen to the pharmacutical company.

For those who like Bextra and can tolerate it, I am sorry that it has

been taken off the market. It is so hard to find meds that work for us

and have one that doesn't promote side effects. For me, it made my

rheumy take notice that I wasn't imagining these things.

in Ct.

Sue wrote:

>I hope they do get it back on the market, then I can switch from

>Celebrex back to Bextra. The Celebrex seems to be working pretty well

>for me, but after starting it, I noticed that my blood glucose readings

>are higher than usual. I hadn't changed my eating habits or exercise

>routine or anything to cause higher readings.

>

>So I looked up the side effects of Celebrex, and there among the rare

>ones are listed diabetes and hyperglycemia. Leave it to me to get rare

>side effects. Like, Arava increased my cholesterol, and that was listed

>as a rare side effect.

>

>I don't know if it's the Celebrex that's raising my BG's or not, but

>it's the only thing that's changed for me. My diabetes has been very

>well controlled, and I don't want some medication messing it all up. My

>prescription is for two 100 mg tablets a day. Because of this possible

>side effect, I've just been taking the morning tablet. Sue

>

April 28, 2005