Doctors Say Avoid Pfizer's Bextra -Medical Journal (2 in the same day!)

[Tab]

HICAGO (Reuters) - Doctors writing in a prominent medical journal on Friday recommended that physicians stop prescribing Pfizer Inc.'s Bextra painkiller, just as a large study found the drug maker's sister drug, Celebrex, doubled risk of heart attacks.

Both drugs are members of the so-called COX-2 inhibitor class of painkillers, which recently gained notoriety when Merck & Co. Inc. withdrew Vioxx in September after a study found it doubled the risk of heart attack and stroke.

A letter by three top doctors published in The New England Journal of Medicine said that in light of Vioxx and negative signs on Bextra, Bextra should be avoided.

"We believe the doubts raised about the safety of valdecoxib (Bextra), constitute a potential imminent hazard to public health" and thus they should be prescribed only in "extraordinary circumstances," editorial writers at The New England Journal of Medicine wrote in an issue dated Dec. 23, but released early.
http://news.yahoo.com/news?tmpl=story&u=/nm/20041217/hl_nm/health_pfizer_bextra_dc

Sheesh. How many more exist in that drug class?

[parkenyc]

1. I heard someone on the radio today,

presumably a doctor, saying that Celebrex should not be taken off the market, and possibly Vioxx should not have been taken off the market. He said the two drugs are designed for people who can't take aspirin because of stomach problems, and it is because those people don't take aspirin that their risk of heart attack is increased.

I did not hear where that doctor worked, but I would assume Pfizer.

[rodeodance]

3. Bextra takers are being asked to call a lawyer (compensation ad)--

The alert/warning for this has been out there on the airwaves for a while now.

[northzax]

5. actually,. for a lot of things, this makes sense

Celebrex and Vioxx were likely overprescribed, all drugs have side effects, and the risks of taking them should be weighed against the benefit. Take Thalidomide. Evil shit. Superiour as a drug for Leprosy. (seriously) worked like a charm on morning sickness as well, although the side effects of that usage were are way out of bounds. Shows great promise on HIV inhibition. However, should it be removed for usage by people who aren't or can't get pregnant? probably not.

should Vioxx and Celebrex, if they really help people who cannot take other painkillers for arthritis, be taken off the market? no, but they shouldn't be marketed either. they should be a last resort for Doctors who are experienced in their use for exceptional patients who do not respond to other treatments and are aware of the risk.

drugs do things to you, anyone on a long term course of drug treatment should be monitored for all side effects, uncluding heart damage.

[parkenyc]

7. Drugs are prescribed too freely.

A friend takes Vioxx, and he is able to take aspirin.

[Horse with no Name]

16. Thalidomide is shedding its tarnished image

And is being used successfully in cancer treatments.
I agree with your statement that there shouldn't be any medication that is marketed by television or radio ad. A patient shouldn't be reading Family Circle and decide they need a new medication.
It should come from careful consultation with your physician.

[w4rma]

13. That's their PR guy that was being paid to say that. (nt)

[LibertyLover]

2. Bextra

I hope that the risk for Bextra is exaggerated, although I suspect in my heart of hearts that it isn't. My husband takes Bextra for fairly severe arthritis and would be utterly miserable without it.

[northzax]

6. the risk is still very minor, you know that

we're talking about 1-2 percent of the people who take the drug. unnacceptable to Pfizer's lawyers, perhaps, but not that great, overall. I know this is small comfort to the families of the unlucky ones.

[Osamasux]

23. Which shows it works.

Hopefully he is not in one of the at risk groups, was not over-prescribed, and will be fine.

[amazona]

35. I feel the risk is very exaggerated

I hope your husband can continue to get his medicine. Bextra can be amazing.

[idiosyncratic]

4. Bextra was wonderful for my severe, painful tendonitis

I don't take it daily, but it is better than eight Alka-Seltzer tablets per day for pain.

[Liberty Belle]

8. Does anyone know what dosages are considered risky?

I've had different doctors prescribe radically different dosages of Celebrex, which I take only occasionally for arthritis pain because I'm afraid to be on it all the time. I'm wondering if the problems arise from high dosages, since the pharmaceutical reps seem to be passing out free samples of those like candy.

[Eloriel]

11. IIRC

400 mg = twice as likely
800 mg = 3x as likely

The segment I saw kept showing bottles of Celebrex marked 100 mg and 200 mg.

[Liberty Belle]

21. I only take 100 mg. Tried 200 and it upset my stomach.

I'm no fan of the pharmaceutical industry. In fact I'm a DES daughter so I know that these companies can't be trusted.

That said, I have written about the vitamin industry extensively and know that often stories about adverse reactions tend to get overhyped, ie, reporting on reactions of people who took excessively high dosages.

While it certainly sounds like the pharmaceutical company didn't adequately test the arthritis drugs and the FDA should've taken action sooner, it doesn't necessarily mean that people on low dosages are at high risk.

Also, it should be noted that some studies have linked inflammation itself to heart problems. So how can you be sure which heart attacks are caused by medication vs. the underlying inflammation--which also manifests itself in arthritic pain?

[screembloodymurder]

26. 200 mg has been shown to be safe

As was reported, the other study showed no significant increased risk at 200 mg. The study that showed increased risk was a trial involving cancer treatment. The dosage, at 400-800 mg was higher than normally prescribed. Previous studies at the lower dosage showed no increased risk.

[SoCalDem]

9. The recent drugs seem to have side effects way worse than what they treat

When I see the commercials for the heartburn one or the psoriasis/exzema one, I think I would have a hard time risking taking them.

The drug companies are rushing these "new and exciting" drugs onto the marketplace before they are "ready for prime time".

The tv watchers are racing to their doctors begging for unproven drugs, and some are paying with their lives.:(

Prescription drugs should have NEVER been allowed to advertise .

[Eloriel]

12. I think it's stunning to listen to these TV ads --

don't take if you have liver or kidney problems.

Hello? This means that if you don't ALREADY have liver/kidney problems, you stand a very good chance of creating them by taking these drugs.

The one that knocks me out is Viagra, for which an acceptable possible side effect is......


.....


.....


.....


........


DEATH!!

[Dear Maggie]

28. Right on - Viagra, too?!

No, death is NOT an acceptable side effect

Neither is kidney or liver damage

& Loss of interest in Sex?

All of the above ailments are also part of a chemical exposure: that to 2-butoxyethanol. (aka ethylene glycol monobutyl ether) From my study of the chemical these past 2 years, I find that kidney and liver and FATIGUE which is hemolytic anemia but seldom diagnosed ... and reproductive harm including lack of interest in sex ...

are part of what this chemical does

and even heart attacks are suspect from this chemical per my observations.

Other things researchers need to do ... for multiple cancer groups and the arthritis group: separate out those with too many immature red blood cells and blood in urine; those with acquired autoimmune hemolytic anemia.

Then you may know whether it is the medication or this particular chemical exposure which is the main culprit.

More http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=102&topic_id=1081089&mesg_id=1082416



More MSDS information on 2-butoxyethanol
www.valdezlink.com/inipol/pages/2-butoxy_msds.htm

Why I've been looking into this
www.seattlepress.com/features/forum/viewtopic.php?p=134#134

[RobinA]

17. Well I Guess That Depends

on whose shoes you are walking in. My mother would gladly risk the heart attack for the pain relief that Bextra gives her.

[SoCalDem]

19. The scary part is that until you HAVE the heart attack

everything's just fine.. Women often do not survive their first heart attack, so that's another concern I have.

My best friend's mother dropped dead on Thanksgiving Day (my friend was only 17).. She had no history of heart problems, didn't smoke, was thin, and ostensibly healthy:(.. You just never know:(

[Dear Maggie]

27. Very good comment

We have noticed the same thing.

I also have a thought for those taking Vioxx & Celebrex:
How many of you also have Chronic Fatigue Syndrome or CFIDS or 'gulf war syndrome?'

The reason I ask is that I suspect the exposure to 2-butoxyethanol to cause these ... and part of the harm is often arthritis. and PAIN So, before doctors are reviewing results of the Vioxx and Celebrex studies, they MUST know this. They MUST check for the fatigue that has not been heretofore found: autoimmune hemolytic anemia.

This sub group MUST be viewed differently that others because I have noticed that heart attack can be part of what happens with this chemical exposure. Maybe people are collapsing with lack of blood; or their heart starts beating 250 beats per minute? (One of the clues that it could be the 'hiding out' hemolytic anemia of this chemical: www.valdezlink.com/same.htm } Other clues: www.valdezlink.com/generic.htm#8 Not every symptom is there, of course, this is just a 'text book comment' most likely from an acute attack


The fatigue is different than doctors expect www.valdezlink.com/why_fatigue.htm and the bones hurting may not be arthritis for this group www.valdezlink.com/paralysis.htm

After studying this chemical for over 2 years, my theory is that regardless of the 'add on symptoms' the fatigue is findable and provable evidence of this chemical's involvement: do these have blood in urine in early years AND red blood cells that are immature?? www.valdezlink.com/psa.htm

[happynewyear]

10. kick!!!

:kick:

[DemoTex]

14. My internist (in Dallas) will no longer prescribe COX-2 inhibitors.

I was there last week for my annual physical and finger-wave, and I asked him about Bextra for my painful tendinitis and arthritis. Since I am already a cardiac risk with hard-to-control diastolic blood pressure (he doubled the atenolol last week ... systolic came down, diastolic has not ... yet), he suggested alternatives (Advil, Aleve, Tylenol Arthritis Strength). I can live with the pain. I cannot live with the high b/p.

[Liberty Belle]

22. There are some natural arthritis remedies you can try.

Ginger pills are natural anti-inflammatories. Turmeric (the spice) is another. I know of no downside to trying these and have taken ginger pills myself with some success.

For joint pain, some people find glucosamine/chondroitin supplements to be very helpful. Only caveat: monitor your blood sugar if you're at risk for arthritis.

FYI, there are some supplements now for blood pressure, though I'm not very familiar with them. If you're interested, visit a Whole Foods or Wild Oats Market. They have a computer where you can look up any condition and find suggested natural remedies. Then go to a pharmacy and ask your pharmacist to check for any potential cross-reactions with other drugs you may take. I think the WF/WM computer may list some, but the staff isn't as well-versed on prescription medications as a pharmacist. Some pharmacists now have training in vitamins, herbs, and other natural remedies, FYI.

[Dear Maggie]

31. Chronic Fatigue Syndrome, too?

Some of these things you mention ... if fatigue of unknown cause is part of it ... may be chemical poisoning or overexposure to 2-butoxyethanol.

Check these: do you have too many immature red blood cells? Have you for earlier years at least, also had trace blood in urine? Check for the harm of a common cleaning/degreaser chemical overexposure. Check out 2-butoxyethanol (aka ethylene glycol monobutyl ether)

It is a poison, a solvent, a pesticide. It causes endocrine disruption of which high (or low) blood pressure can be a part. Often thyroid and other glands including pancreas can be involved, so even high (or low) blood sugar may also be a secondary harm of this chemical.

And pertinent to this discussion thread, it may cause heart attacks. So researchers in many fields should evaluate whether or not this cheimcal is the primary or root cause prior to concluding what the research means.

Some MSDS information on 2-butoxyethanol
www.valdezlink.com/inipol/pages/2-butoxy_msds.htm

[Horse with no Name]

15. I am a nurse

and injured my back at work. I refuse to have surgery, because that is just buying into an entirely different set of problems--some which could possibly worse than the ones I have.
I refuse to take other prescription pain killers, because I have seen so many people addicted to them--and their lives ceasing to exist for the want of the drug. One of my friends is so addicted to Oxycontin after her back injury that her life revolves around her next scheduled dose of it. Everything is in relation to when her last/next dose is. I can't live like that, nor will I.
I have endured pain for months and months--sometimes excruciating. I took Celebrex--it didn't work.I took Tylenol, Advil, Aleve, et al. without success.
My neurosurgeon finally prescribed Bextra. I have been on it now for several months. For the first time in over a year after I took this medicine, I was able to function at a level that was acceptable to me. Of course--I still have a small degree of pain--and it doesn't help with the numbness, but the discomfort is tolerable.
I started a new business to incorporate my nursing skills and education because I cannot return to bedside nursing because of the injury, and since i live in Texas--you can forget Workmans Comp--it is the most corrupt system in the country (thanks dubya), so I had to get back to making a living.
A large percentage of my clients are attorneys.
Was recently in one's office...and we were talking about why I started my company, etc, and I told him about my back injury and my path back to the working world and the role that Bextra has played in it. He almost fell over in disbelief that I was still taking it after all of the literature.
The only explanation that I have is...that if you cannot get out of bed in the morning to function...and this drug makes it possible to do that, it is worth the risk, at least it is for this patient.
I do not understand why all patients cannot be responsible and either accept or deny the risks of the medications that they choose to take. With each drug prescribed in the US--the patient is given information about the side effects and potential liabilities of the medication. This is a federal law. They should decide for themselves if the benefit to risk ratio is adequate enough for their needs. No patient should blindly take medication that they do not understand what it is for or what the potential side effects are.
I know that these drugs will all be removed from the market due to patient irresponsibility and lawsuits. This is a tragedy for people like me who are willing to accept the risk of the treatment, because after all, the alternative isn't acceptable either.

[Sgent]

18. Some options

For people that are having serious pain..

There are over 15 NSAIDS that have been approved for arthritis pain every one of them considered to be equally as powerful for pain as the normal doseage of Viox and Bextra. I agree w/o question that experimenting is not fun, but keep in mind that over the counter meds are not the only ones available -- Relafen, Voltran, and Motrin or Naproxen in perscription strength is a stronger medication. Most of these are taken every 12 hours, and some every 24.

The great breakthrough of the Cox-2's is that:

1) People with a history of ulcers can take them.

2) People with GERD can take them

3) This is the biggie, people on blood thiners can take them. NSAIDS are contraindicated for people on blood thinners (which are a larger percentage of the population than you might think), because they can cause uncontrolled bleeding and stomach ulcers. If your platelets are non existant, you could have a serious medical crisis.

One other thing to note: do not take tylonol for long periods of time. It is considered unsafe as it builds up liver toxins faster than your body expells them. Although not a problem for a short period of time (couple of weeks), it has caused severe liver damage in many people in the past.

[hyphenate]

30. The problem with the cox-2 inhibitors

with some patients, including myself, is pulmonary edema and peripheral edema. These both can lead to cardiac failure or congestive heart failure.

Many people can not guage the amount of edema they get when on a medication, but it's easy to spot: look for swollen ankles or pitting edema: press your finger into your shin and hold for a good 5 seconds. Remove, and see how quickly the "dent" comes back to normal. If it's longer than a few seconds, then you have edema present and it's time to consider stopping the medication causing it.

I have too many illnesses to name, but the significant one is fibromyalgia in this case. I was on celebrex for awhile, and it was building up a lot of fluid in my system. I got off it as a result. When I saw my doctor about 8 months ago, she gave me some samples of Bextra, and it began to happen again, so I didn't stay on them longer than a week. I can't take narcotic pain relievers because they make me nauseous, and I won't take them either for that reason.

I also have GERD. That, at least, is treatable with Protonix. If I go without my Protonix for two days, I am in agony with acid stomach and regurgitation. Because it is so severe, I will happily stay on the Protonix. I can therefore, as a result, go onto an NSAID that will help with the pain.

As I was taking about 800-1000mg of Ibuprofen a day, I decided to see if another NSAID would be better in terms of dosage and effect. I went on Naproxen (aka Anaprox) instead, and it's worked out very well.

I read and research all medications. The best website for this, for those interested, is http://www.rxlist.com. It is the equivalent of the PDR--Physician's Drug Reference, which not only details the indications for medications, but also gives you contraindications, side effects, dosage, warnings, etc. I've had some medical training, so it's a good continuing education.

If you have a single risk factor toward heart disease, take that into consideration. When you go onto any medication, it's wise to do your own research on it as well as accepting the word of the doctor. Many drugs have a deleterious effect on the liver or kidneys....this can be closely monitored through regular bloodwork.

For my fibro, and for the many other orthopedic problems I had, I found a single nighttime dosage of Flexeril, in combination with the Naproxen got rid of the horrendous morning pain I had. A Naproxen in the morning completes the regimen.

There are definitely people who can't take NSAIDs but the risk is a lot less than those who are taking a Cox-2 inhibitor, of which Vioxx, Celebrex and Bextra are all examples. My mom has horrible stomach problems, most of them from ulcers and diabetes. The Vioxx had worked well for her. However, she is currently taking only OTC Tylenol, and it seems to help her.

Every person is different. I have found certain BP/heart medications intolerable, and found the only one that works for me is an older one, Propranolol. Atenolol was making me feel like I was breathing underwater, with labored breathing and complete loss of stamina, and Lopressor was not strong enough. However, these medications are good for other people for which it works. All of our bodies are different, and the ways to help us get through medical problems are often hit or miss. But we need to be informed about the medicines which are going into our bodies, be aware of the side effects and drug interactions, and we need to be able to discern whether the side effects are trivial or not in comparison to the benefits of the drugs. Those who can work with the doctor in a more informed way are the ones who can benefit the most from medications, while those who simply take a drug because their doctor has prescribed it are not gaining much in the way of help. Doctors are not infallible, and may even not have a right diagnosis for some people.

[Liberty Belle]

24. Have you tried chiropractic, acupuncture or massage?

I recommend them in that order.

Since your pain is from an injury, it may well be something that a good chiropractor could fix, especially if you've got nerve pain/numbness down a leg or other signs of a disk out of place. I once got hit on the head by a falling tree and got a bulging disk. The pain was driving me out of my mind and the orthopedist told me to live with it. I saw a chiro, who did one pop and the pain instantly went away--miraculous, and I'd been a total skeptic of chiros before.

I write about alternative medicine for an international trade journal. These treatment methods are now accepted by most mainstream doctors, unlike in the past. FYI, I've done all three of the above treatments, if you have any questions. They worked well for some injuries and less well for others. I've been in several car accidents and a workman's comp accident besides the tree incident, so unfortunately I'm an expert on pain treatments.

[Dear Maggie]

29. What about those with Chronic Fatigue Syndrome?

Your comments are well noted.

There is another whole group of people whose very 'arthritis' may actually be bone damage from a common cleaning/degreaser chemical. It seems to NEVER be blamed for anything. And I suspect it to be the root cause of much arthritis, Fatigue which is autoimmune hemolytic anemia that doesn't usually show up in hemoglobin or hematocrit, and Many cancers.

I've noted that people harmed by this chemial, 2-butoxyethanol, are also more at risk for heart attack as a secondary harm from it.

So which came first? the chicken or the egg?

http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=102&topic_id=1081089&mesg_id=1082416

& reply to
http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=102&topic_id=1081089&mesg_id=1081504&page=
Right on! and Viagra, too? !

Why I've studied this?
www.seattlepress.com/features/forum/viewtopic.php?p=134#134

[BenDavid]

20. Well hell,

I guess by the time this is all over,us men folk will have developed heart problems and what damn use will lavitra,cealis,viagra be? I guess on the tombstone it will read, He came:D and went:( at the same time.

[proudbluestater]

25. FDA=nothing but shillers for the drug companies

[Sgent]

32. 2-butoxyethanol

I did some investigation on the literature out there on this chemical solvent (2-butoxyethanol) at the request of one of the members on the board.

It seems that all reported cases of 2-butoxyethanol poisoning, amongst other factors, have a anemia associated with them -- specifically the red blood cells don't develop to their usual capacity.

A CBC (Complete Blood Count), a test often performed in the physician's office, will notice that there is something wrong with the Red Blood Cells. This being the case, the doctor should investigate the cause of the problem.

Although their are a variety of side effects reported, the only ones that tend to be the same across people, and as a ruslt of chronic exosure, are the RBC as mentioned above (which can cause fatigue, listlessness, etc.) and liver cancer (almost completely non-existant in the US). In acute cases, such as someone injesting it, it has been known to cause respritory depression (unconsiousness, breathing problems, etc). It also has been shown to elevate liver enzymes. One study in Isreal indicated that it also increased red blood cell "stickyness" -- which could lead to edema or heart issues as well.

One final note, although there is treatment for acute exposure (inject alcohol), there seems to be little consensus on treatment of a long term issue -- assuming its even treatable. I would not recommend drinking this stuff (as some have done), and I would avoid daily exosure to it, but since it is still an alcohol chain, it should be able to be broken down in small exposures.

[Dear Maggie]

33. Seems like emphasis is right on 2-butoxyethanol

Red blood cell damage as described; more particularly it is hemolytic anemia per some MSDS info on the chemical

I also noticed that info says liver counts go up when red blood cells are immature, per definitions on what other tests are off when too many red blood cells are immature.

The researchers, however, don't realize what I suspect: that the worst exposure is through the eye membranes & cuticle areas. Some MSDS info has suggested that ingestion is not an exposure.


Liver cancer? Well this chemical doesn't get the credit for it, but I suspect this was more likely than not the cause of this woman's liver tumors (had a cancer name, but I don't remember what):


Everyone was focusing on her liver cancer www.valdezlink.com/health_survey_for_doctor.htm#liver ... but at the time of death, two months ago, Sue was also said to have brain tumors.

When you look at what the pattern is for 2-butoxyethanol & the cancers that it can cause. You are dealing with a chemical that is in rampant use in our society, and it has been so for over half a century. Though largely unapplied to humans, I believe it is the root cause of much health harm, including cancers. Which one shows up first is sort of irrelevant, as it is a chemical that targets multiple body systems, either singly or in combo.

Sue, died in Valdez, Alaska on 9-29-04 This is what I suspect with her:

Her death certificate will say that it was from liver cancer.

It was the kind that didn't respond to chemo-therapy nor surgically removing the tumors. Her liver was so swollen it looked like a watermelon. Her legs were swollen from the liver not working right.

She had developed thyroid problems with resultant kidney stones. She said she had these horrible headaches www.valdezlink.com/complete.htm#headaches since she was 5.... her parents frequently took her to the emergency room for them, too. Her mom ended up dying of kidney cancer.

I saw her have one of those debilitating headaches one time, and she was white as a sheet. I said, Sue, you have some 'add on signs' indicative of the harm 2-butoxyethanol would cause. Ask your doctor to test for whether or not you have too many immature red blood cells. She did have too many immature red blood cells. The doc said, "So, now what do we do with this information?"

I asked her to check back and see if any of the old urinalysis showed trace blood in urine. I don't think she did. Although she said she would ask the doctor about it.

She leaves behind 2 barely grown daughters, 2 little grandsons and a boy half raised, he is 14.

Too bad they don't select 2-butoxyethanol poisoning with liver cancer as a secondary cause of death ... on the death certificate. It's a pretty strong possibility.

Once that is determined to be the identifying marker of 2-butoxyethanol, the blood in urine, and the too many immature red blood cells from hemolytic anemia (the Fatigue) ... maybe there will be this diagnosis for others in the future.

Sue had a number of the signs of this chemical's harm, and that is why I suspect it as being the root cause of her health ailments. First cancer she had was rectal skin cancer. Now, if that had been treated earlier, would she not have had these other things? Would there not have been a 'spreading' to other areas? She was said to have brain tumors at time of death, as well. ( I suspect that the brain tumors that took Thelma's life were from this chemical exposure to her father?) www.valdezlink.com/inipol/pages/thelma.htm

Well, if it is poisoning from 2-butoxyethanol that caused it, it is also a chemical which directly targets other organs/glands www.valdezlink.com/organs_affect_list.htm ... so most likely they would have occurred whether or not she dealt with the first cancer sooner.

Others:

There are multiple cancers that 2-butoxyethanol can cause. Which one shows up first is sort of irrelevant. It is attacking multiple body systems at the same time. Lots of times smoking gets the blame, so lung cancer was from smoking and that it just spread. Howard first had lung cancer; ended up dying from brain cancer. Del had lung cancer, bone cancer, lymph cancer, liver cancer. Oh, he was a smoker, you know. Well he also worked on the Exxon Valdez oil spill cleanup, and was very likely exposed to the harmful cleanup chemical, 2-butoxyethanol.

[Dear Maggie]

36. What about liver ailments in children of those?

www.democraticunderground.com/discuss/duboard.php?az=view_all&address=222x88#134

Reply to a question on a child who died ... liver ailment

[amazona]

34. I guess they expect us to just live in pain

Opiates are not prescribed because they get the doc on a DEA list and now a whole class of drugs that doesn't interfere with ability to function is being taken off the market.

I'm tired of the attack on pain medicine. Sometimes a slight risk is worth it, because life is not worth living if all you can do is scream in pain and beg to die, as happened with my friend's dad.

No drug is perfect. All have risks. Do they intend to make it impossible for anyone to seek legal relief from pain?