Risk linked to some painkillers creates dilemma

May 11, 2005

Houston Chronicle

04/17/2005

Apr. 17-- Lacy, 74, sweats through exercise classes two times a

week to strengthen muscles and ease the pain in his lower back and

knees. But it's not enough, so the Houston resident depends on a

prescription pain drug, knowing it may pose a risk to his

cardiovascular health.

" I'm living in tolerable pain. I think without (Celebrex) it would be

intolerable pain, " Lacy said. " So it's worth the risk, for now. "

For Lacy and millions of other Americans suffering from arthritis and

other disorders, choosing a painkiller seems more risky each day.

Nearly all of the most popular prescription and over-the-counter pain

pills are now seemingly suspect, with wonder drugs Vioxx and Bextra off

the market altogether.

The recent cascade of bad news about pain pills is not only creating

concern and confusion among consumers, it's frustrating doctors --

including some who say sweeping federal regulatory action is not

strongly supported by scientific data.

" It's really hard. There are people who are like, 'I can't get out of

bed without this. What am I supposed to do?' " said Dr. Smart,

director of advanced heart failure and cardiac transplant at the Texas

Heart Institute at St. Luke's Episcopal Hospital. " What I'm telling

them is, if you can do without it, do without it. The less, the better.

Because I do think there is a risk. "

On April 7, the U.S. Food and Drug Administration -- smarting from

criticism for allowing the arthritis drug Vioxx to stay on the market

four years after safety concerns arose -- asked Bextra maker Pfizer to

withdraw its drug.

Cautionary informationAt the same time, the FDA announced it will

require stronger warnings about possible risk of heart attacks and

strokes on Celebrex, the only selective COX-2 inhibitor still available

to consumers. In addition, it wants the makers of older non-steroidal

anti-inflammatory drugs, or NSAIDs, such as Aleve and Advil, to include

prominent cautionary information.

When COX-2 inhibitors came on the market, people were excited because

the new pain drugs promised relief without irritating the stomach (as

can aspirin) or damaging the liver (as can Tylenol in high doses).

COX-2 drugs were " selective " in that they suppressed an enzyme linked

to pain mediation, cyclooxygenase-2, while leaving an enzyme that

protects the stomach lining, cyclooxygenase-1, alone. (Older NSAIDS

naproxen and ibuprofen don't distinguish between COX-1 and COX-2 and

suppress both.)

As it turns out, the two enzymes balanced each other out regarding at

least one important function in the body. Studies now show that Vioxx,

which is the most selective about tuning down pain, inadvertently

turned up the dial on clotting -- a cause of heart attacks and stroke.

Research on an intravenous form of Bextra given to coronary artery

bypass patients showed a similar threat, and FDA officials reasoned

that risk likely extended to all Bextra users.

Studies on Celebrex have been mixed, experts say. That drug is probably

less risky because it's not as specific, or selective, in suppressing

cyclooxygenase-1 or -2. But federal regulators want to see more

long-term study data, and they want the public to be aware of potential

problems with older NSAIDS as well.

That stance is troubling to some physicians.

" These drugs (NSAIDs) have been on the market for decades. It is highly

questionable that they have significant cardiovascular effects, except

perhaps in older patients, " said Houston orthopedic surgeon Dr.

Watters.

Dr. Marcus, a rheumatologist with Baylor College of Medicine,

thinks the FDA's call for warning labels on all NSAIDS " is unwarranted

by the evidence. Also, it may turn some people toward alternatives

(such as herbs), which are unregulated. People don't realize they're

hazardous also. ... The FDA's really unsound recommendation is based on

desire to protect their rear-ends. "

General internist Muntz, a team physician for the Houston Astros

and the Houston Rockets who also sees older orthopedic patients, said

he is taking into account his patients' risk factors for heart disease

when he prescribes pain medicine. Those with normal cholesterol, who

are nonsmokers and don't have a significant family history of heart

trouble, " I'd be comfortable putting them on, or leaving them on the

COX-2 drugs or using the COX-1s without much concern, " he said.

Although some people swear by Vioxx, Bextra and Celebrex, a strong

psychological component may also be at work. According to ,

a pharmacist and a professor at the University of Houston's College of

Pharmacy, large clinical trials have not shown those drugs to have more

pain-relieving power than older NSAIDs such as Aleve and Advil.

" There's never been anything to say they are more effective, "

said. " So the big question is, where am I going to take my risk? On the

stomach? Or the heart? "

PAIN PILLS AT A GLANCE:

Available, with strong warnings about heart and gastrointestinal risks:

-- Celebrex: New-generation NSAID, possibly associated with increased

risk of cardiovascular problems. FDA said benefits outweigh potential

risks in properly selected patients. Drug maker Pfizer has agreed to

undertake a large study of Celebrex's effects on the heart.

-- Naproxen: sold as Naprosyn, Aleve and other names. Older-generation

NSAID. May be mildly protective of the heart in certain patients.

-- Ibuprofen: sold as Motrin, Advil and other names. Older-generation

NSAID.

Off the market:

-- Vioxx

-- Bextra Still OK:

-- Acetaminophen: sold as Tylenol and other names.

-- Aspirin

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go to http://www.HoustonChronicle.com

May 11, 2005

I strongly disagree with the statements below. I don't care what their

clinical trials showed. I know what is true for me. The first drug I

took for my RA was Aleve. I started it before diagnosis, and then the

rheumy told me to continue on it. It didn't really touch my pain, and

also gave me a bleeding ulcer. I finally went on Bextra, which was

extremely effective in relieving my pain. Several times I stopped

taking it for 4-5 days to see if how I could do without it. Each time,

the pain came back. I switched to salsalate, which didn't relieve the

RA pain and also caused stomach pain. I went back to Bextra, but then

they yanked it off the market. I'm now on Celebrex, which does a decent

job of relieving the pain, but not as well as Bextra did. It seems to

also be increasing my blood glucose, which is not good, since I have

diabetes.

There is just no comparison between the effectiveness of Bextra and the

other NSAIDs that I've tried. I don't understand why they keep saying

that the -2's are not more effective than the older NSAIDs. For me,

they certainly are (with the exception of Vioxx). What works for one

person doesn't always work for someone else. Now we have fewer choices.

Sue

On Wednesday, May 11, 2005, at 07:13 PM, a wrote:

> Although some people swear by Vioxx, Bextra and Celebrex, a strong

> psychological component may also be at work. According to ,

> a pharmacist and a professor at the University of Houston's College of

> Pharmacy, large clinical trials have not shown those drugs to have more

> pain-relieving power than older NSAIDs such as Aleve and Advil.

>

> " There's never been anything to say they are more effective, "

> said. " So the big question is, where am I going to take my risk? On the

> stomach? Or the heart? "

May 11, 2005