It is an article posted in Clouds that I thought was worth reading. Phyllis already knows about the stuff.
Doctors are beginning to worry that Vioxx and Celebrex, two wildly popular arthritis drugs, may not be as safe as they were initially believed to be.
Research presented to the Food and Drug Administration earlier this year showed that patients taking Vioxx, a Merck & Company drug, had a higher, but still relatively low, risk of heart attacks than patients taking an older pain reliever. The study received little public attention at the time, but the F.D.A. is considering whether to add information on possible cardiovascular side effects to both drugs' labels.
Now Wall Street is becoming aware of the possible problems, with at least one analyst warning that the problem could particularly affect Merck.
The two drugs, which cause fewer ulcers than many other pain relievers, are among the best-selling medicines in the world. And both Pharmacia, which makes Celebrex, and Merck are heavily dependent on the drugs for the sales growth that Wall Street expects.
Celebrex is Pharmacia's biggest-selling drug, generating sales of $2.3 billion in the 12 months ending in March, according to IMS Health. Pfizer co-markets Celebrex with Pharmacia. Merck sold $1.7 billion of Vioxx in the same period, making it the company's second-biggest drug behind the cholesterol medicine Zocor.
Millions of Americans have tried Vioxx or Celebrex, many of them prompted to request them from doctors after seeing television advertisements paid for by the two companies, which are locked in a fierce marketing battle.
While the data is still limited, a large study sponsored by Merck last year showed that patients taking Vioxx had four times the risk of heart attacks of patients taking another pain reliever, naproxen, which is sold both generically and under the brand names Naprosyn or Aleve. The risk, which appears to increase over time, was still low, however, at about 4 heart attacks per 1,000 patients.
Merck says the research does not show a problem with Vioxx. Instead, the company says, naproxen acted to reduce heart attacks by working much like aspirin.
The information from Merck's study was presented to the Food and Drug Administration in February when the companies asked for changes on their drug labels to reflect data showing that Vioxx and Celebrex caused fewer ulcers than other pain relievers.
In an April 27 report, Richard R. Stover, a pharmaceutical industry analyst at Arnhold & S. Bleichroeder Inc., did his own analysis of what he called "disturbing data" from Merck's study. In an interview, Mr. Stover said he was warning his clients, many of them institutional investors who hold Merck shares, that they should watch the issue carefully since it could hurt the company's stock price.
Some doctors, however, say they are worried about both drugs.
"There must be a warning," said Dr. M. Michael Wolfe, chief of the gastroenterology section at the Boston University School of Medicine and a member of the F.D.A. advisory committee that reviewed the issue earlier this year.
"The marketing of these drugs is unbelievable," Dr. Wolfe added. "I'm sure there are many people out there who are taking these drugs that should not be."
Several doctors say they are worried about the possibility of heart attacks because many of the arthritis patients taking the drugs are elderly and have a higher risk of cardiovascular problems to begin with.
The current debate centers on whether the higher heart attack rate found in patients taking Vioxx is a result of the drug's actually causing damage in some patients or to an absence of the heart-protecting benefits that naproxen may have.
Merck's scientists say that naproxen appears to help reduce heart attacks by stopping or slowing the production of a substance called thromboxane. Thromboxane is thought to cause platelets in the blood to stick together, leading to blood clots.
"Naproxen had a similar antiplatelet effect to aspirin," said Dr. Eve E. Slater, senior vice president of external policy for Merck's research labs, "and those people had fewer heart attacks."
Neither Vioxx nor Celebrex have been shown to have the same heart- protecting benefit.
Dr. Slater also said that Mr. Stover's report was flawed and biased in favor of Pharmacia.
But regulators and some doctors say they still worry that there may be more of a problem with Vioxx.
And even if Vioxx and Celebrex do not damage the heart, the fact that they do not have the heart-protecting benefits of aspirin reduces the ability of the companies to market them as being significantly safer than other pain relievers.
In letters sent to physicians involved in Vioxx clinical trials, Merck recommended last year that doctors consider prescribing low doses of aspirin to patients taking Vioxx if they are at high risk of heart attacks. But those low doses of aspirin could increase the risk of ulcers — the main side effect that both Vioxx and Celebrex were developed to avoid.
The two drugs, known as Cox-2 inhibitors, have been shown to significantly reduce stomach ulcers compared with pain relievers like aspirin and ibuprofen. In rare cases, serious ulcers can lead to death.
So far, no studies have been done to measure whether patients have fewer ulcers if they take low doses of aspirin with either Vioxx or Celebrex.
At an F.D.A. advisory meeting in February, Dr. Maria Lourdes Villalba, a medical officer at the agency, summed up her analysis of Merck's study, saying that the company had proved that Vioxx, which is known generically as rofecoxib, caused fewer serious ulcers than naproxen. But she said that in her opinion, the potential safety advantage was offset by a higher risk of heart problems.
"Over all, there was no safety superiority of rofecoxib over naproxen," Dr. Villalba concluded, "mainly due to an excess of serious cardiovascular events."
Dr. Villalba said that because there were no studies that proved Merck's theory that naproxen worked like aspirin to decrease heart attacks, the F.D.A. was concerned that the higher rate of heart attacks found with Vioxx might have been caused by the drug's producing blood clots.
Both Merck and Pharmacia say that patients taking either Vioxx or Celebrex and low doses of aspirin will still have fewer ulcers than if they were taking a drug combination like ibuprofen and aspirin.
Dr. G. Steven Geis, Pharmacia's vice president for arthritis and cardiovascular clinical research, said, "We believe that if a patient is on low-dose aspirin and needs a drug for arthritis, celecoxib is a good option."
Celecoxib is the generic name for Celebrex.
Dr. Slater of Merck said, "There is still a tremendous benefit from taking it.
Finally back home to stay. Have been bouncing around like a rubber ball that past 3 weeks. Trying to babysit at my daughters, and then come home, back again, and so forth. My granddaughter wanted to come home with grandma and papa for a few days, so we brought her back, had some plans to be at the lake, and she got sick. Running high fever, but only for a couple of days, and was alright again. I am tired and hurting. I hurt my back again bigtime. Don't exactly know what I was doing to do this, but it sure is sore - and that brings about another problem with a little fm flare. Can't win.
Hope everyone else is fine. Meme, hope your headache is subsiding. We haven't even had any rain until last night. We had a thunderstorm, a downpour and then nothing. May get a shower again today. It has been in the 80 and 90 degrees here and that is unheard of for the month of May. Broke all kinds of records.
Ally - mams are too big? Is that what you said. Lots pay a fortune for that! But it sure is fun when they squeeze them in that wonderful machine they have. I am sure it was invented as a torture machine first.
Candice - I must go out and pull weeds, but can't do it now. Will just have to wait. That recipe sounds delicious and I will give them a try - soon.
Phyllis - hope you are feeling better. Is it for sure arthritis in your hip or back? Or are they still not sure. Can't remember what I read, and I have been off the board so much lately.
Hello all. Happy, thank you for that Vioxx/Celebrex info. I WANTED to try that when I was trying so hard to figure out what would help with pain. My DOc said my ins company wouldn't cover until I had tried others and failed. In the end it wouldn't have done one bit of good cause my problem is all in my muscles, not in joints. But I was desperate and would have tried anything. Glad I didn't do it.
Is is sad that those of us just trying to get relief from pain can't rely on drug companies to test these drugs to avoid getting unsuspecting people into something that will hurt them.
Gotta go.....will check back later
Hi...headache is gone but arthritis/fibro pain is not! I took the methotrexate so...we'll see I guess. But it will be a month or so. I dread the wait!!!
Anne...good to have you back...have missed you!
Hello to everyone else...hurting too bad to "talk" tonight. Sooooo glad I have the next 3 days and nights off! Gonna get some real rest (hopefully). Daughter knows how bad I feel and I had hubby let some not so subtle hints fall to son so maybe they will leave me alone this long weekend. I rented Remember the Titans and The Whole Nine Yards and plan on just laying around (after I get the house semi cleaned up tomorrow...hubby said he'd help!) The rain is supposed to be about over so maybe I'll feel a little better in a day or so!
I have been going outside during rain drips( yes I said drips) to try and get some yard work done..still have some planting to do too.
The dog seemed better today, still limping but more energy so I cleaned her room up, swept and mopped the floor( we have a yucky damp basement so it is hard to get excited about cleaning it, you can't tell that anything has been done!)
Meme..glad your headache is better and hope they leave you alone for awhile! I feel better pysically since I have been eating better, I am able to do more too it seems with out so much pain..knock on wood(thump, thump). My email is still being upgraded! I still want to know how to crop and size pictures I have something called imaging on this new puter but can't figure it out!
Anne....ya think that post was long enough! Glad you are back with us!
Ally..They used to give all Fibro patients arthritis meds, they tore up my stomach years ago and then they found out we didn't need them if you didn't have arthritis! Nothing helps these muscles when they jurt!
well here I be and I'm sleepy as usual, but no sleep. Just toss and turn and turn,
Well, this is the big weekend and because I moved hee in Nov. I haven't gone anywhere because, I'm "away" already.
My son and his friend the Captain of a USN vessel stationed in Coprus Christie is here for the weekend. Had dinner for them this eve and the mommy stayed home waiting for the new baby to come. She said she feels quizzie so maybe that's a sign.
Everybody has been tired and achy it seems, but you guys keep going and going like the little rabbit.
{In the drizzel too}
Can't stand this feeling of tiredness but no sleep.
Have had trouble entering the site, even had to re-register.don't know why.Maybe it's a hint?
seeya!!!
Hope you are all enjoying your Memorial Day weekend. We had a long weekend last weekend. They are so nice and everyone looks so forward to them. What are you all doing?
Phyllis - get a wiggle on and join a group or something, where you can go meet people. I am sure that your son enjoys having you near, but just the same, nothing like someone our own age for good company.(Unless you like 'um young)lol.
Meme - glad to hear that the headaches have subsided. I have let this diet slide as well. It seems impossible to do it when I am not even home. Lots more eating out and out at familiy memeber homes. So can't control what I need at all. Then being home for just 3 days at a time, didn't bother much with groceries. Now my back is so sore, I can't be bothered with anything. Just want it to go away. Have trouble sitting or standing for too long, so walk and lay. What a life! Hope things are working better for you with regards to the church.
Candice. You must have more flowers than a greenhouse(lol) Way to go. I went out and pulled some weeds yesterday, and that was a very stupid thing to do. Could hardly move later in the afternoon. Back just seized up.
Ally - Hi. Hope you are doing ok. How is your son doing now? You know how men are when they get a little sick, well I can just imagine how a boy would be when he can't get around! Imagine! what am I talking about. My son tore a ligament in his ankle and had to be on crutches for 6 weeks. Had a half cast to hold his foot and then it was strapped with a tensor bandage. The thing was no weight was to be put on it. You would have thought it was the end of the world. Just couldn't do everything he wanted and there is nothing worse for a teen than being held back by something like this.
You are all having rain and storms it seems. Here, we have hardly had any rain at all, and the temp. this week has been in the 80-90 degree range. Way to hot for me. We have a dry heat here at least. The humidity would do me in, I am afraid. Maybe some shower activity by Tuesday. The thing that worries me, is it could well turn out to be tornado weather. I have never seen a tornado, but have seen the results when one whipped through Edmonton 11 or 12 years ago. Only one ever. Then last year, just a few miles from here, Pine Lake had a tornado, and several people were killed and severly injured. It is a holiday place, so people were in camper type accommodations. Very sad.
Happy......I got caught in one of those thunderstorms today in the cemetary with my dogs. We got soaked.
My sons have a friend over and are occupying the good TV. I don;t know why I ever got them TVs for their own rooms...they just watch the big one.
My son with the broken leg is getting a little annoying and annoyed. His brother likes to take off and leave him alone and lonely. He might be able to start putting some weight on it soon.
Meme....Remember the Titans was good. Made my son want to get back into football. The Bruce Willis one I found disappointing. I wanted a nice long weekend alone too. No such luck.
Candice... Did you say you've forgotten the diet too? Uh oh, you're the one I count on. I had picnic food today...even potato salad and a roll. I just didn't feel like dieting.
Tootie...what happened with the Zoloft?
Tomorrow, I have a trip to K-mart planned for excitement. Have a nice Memorial Day.
I got quite emotional today at the Cemetary watching all the flags whipping in the rain over many many graves.
Talk about a LOOOOOONG weekend...rain is NOT over and I'm NOT alone! Hubby was supposed to go fishing today with son and s-i-l but it rained them out!!!
I'm with you Meme. My kids' friend is still here and it is raining and I have been feeling frustrated all day. Went to K-mart and spend a ton and still didn't feel right.
Almost WANT to go to work tomorrow to get out of the house.
Tootie....Sorry you lost your thoughts. Let us know what you were thinking. I haven't lost a post in a while...knock on wood.
Candice....quit cleaning. Its a holiday
Meme..my Dh went fishing and when he got home he sat and watched me plant flowers and then said let's do it in the garage! No way hose...........is that all men think about! He went in the house and pouted..said later I didn't even talk to him and it was his day off! Go figure..I was busy!
I can't just sit around like him..I have to keep busy when I have the energy!
HI Ally, toots and Anne!
This is by my back door..it is the west side of the house. The pink flowers are soapwart and blue ones iris. Bloom in late spring.
Hello - I am new to this spot. I say in one of the threads that you do talk about different subjects-- I say in one of the treads where it is a no no to eat night shade veggies and I think pasta was mentioned because they cause the symtoms of arthritis and lupus to increase. Can anyone help me out on this subject. I have looked all over and can't find the answer. My sister has lupus and I have arthritis.
Yes Candice That is generally what all men think of. My husband is 76 and that is his favorite passtime. After 50 years with him ,I don't think it will change.
Joanne
Joanne, welcome to our little group. We do talk about many different things here, things that go on in our day to day life and things that can cause a flare in fm or arthritis. I also have arthritis. In answer to your question about eating certain foods, I went looking for Lupus and this is what I found.
Eat a diet low in fat, salt and animal protein - this kind of diet is easy on the kidneys. Use only canola or olive oil. Consume sardines often. They are a good source of essential fatty acids.
Eat asparagus, eggs, garlic and onions. These foods contain sulfer, which is needed for the repair and rebuilding of bone, cartilage and connective tissue and aids in the absorption of calcium
Include in the diet, brown rice, fish, green leafy vegetables, nonacidic fresh fruits, oatmeal and whole grains.
Use some form of fiber daily.
Do not consume milk, dairy products or red meat. Also avoid caffeine, citrus fruits, paprika, salt, tobacco and anything that contains sugar.
Avoid the nightshade veggies (peppers, eggplant, tomatoes, white potatoes). These foods contain a substance called solanine, which can contribute to inflammation and pain.
Get your iron from food sources, not supplements. Taking iron in supplement form may contribute to pain, swelling and joint destruction.
Avoid strong sunlight and use protection from the sun. Go out in the sun only when necessary.
Avoid using birth control pills. They may cause lupus to flare up.
For arthritis:
Eat more sulfur-containing foods, such as asparagus, eggs, garlic and onions. Sulfur is needed for the repaid and rebuilding of bone, cartilage, and connective tissue, and aids in the absorption of calcium. Other good foods include green leafy gegetables, which supply vitamin K; fresh vegetables, non=acidic fresh fruits; whole grains; oatmeal; brown rice and fish.
Consume foods that contain the amino acic histidine, including rice, wheat and rye. Histidine is good for removing excess metals from the body. Many people with arthritis have ghigh levels of copper and iron in their bodies.
Eat some fibre, such as ground flaxseeds, oat bran or rice bran daily.
Reduce the amount of fat in your diet. Do not consume dairy procucts, milk or red meat. Also avoid, caffeine, citrus fruits, paprika, salt, tobacco and everything that contains sugar.
Avoid the nightshade vegetables (see above in lupus)
If you take Ibuprofen or other non-sterodial anti-inflammaory drugs(NSAIDS) aboid sodium(salt) which causes water retention. Spread doseage of these meds out through the day, take them only after eating, and take an antacic an hour after taking the drug.
Don't take iron supplements - get it from food we eat, such as blackstap molasses, broccoli, brussels sprouts, cauliflower, fish, lima beans and peas.