FDA Issues warning on Naproxin (Aleve)

[Cooley Hurd]

http://www.fda.gov/bbs/topics/news/2004/NEW01148.html

FDA Statement
FOR IMMEDIATE RELEASE
Statement
Dec. 20, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA



FDA Statement on Naproxen
The FDA today released the following statement on NIH halting a clinical trial involving non-steroidal anti-inflammatory drugs in patients at risk of developing Alzheimer's Disease:

The Food and Drug Administration (FDA) is working with the National Institutes of Health to review the available scientific information on naproxen following the decision of the National Institute on Aging to halt a clinical trial studying non-steroidal anti-inflammatory drugs in patients at risk of developing Alzheimer's disease. Preliminary information from the study showed some evidence of increased risk of cardiovascular events, when compared to placebo, to patients taking naproxen.

In the meantime, FDA advises patients who are currently taking over-the-counter naproxen products to carefully follow the instructions on the label. Patients should not exceed the recommended doses for naproxen (220 milligrams twice daily) and should not take naproxen for longer than ten days unless a physician directs otherwise. Patients with questions about naproxen should consult their physicians.

Naproxen was first sold as a prescription drug under the trade name Naprosyn in 1976. FDA approved its use as an over-the-counter drug in 1994.


####

[Pirate Smile]

1. What did the warning concern?

[Warpy]

16. All of those early NSAIDs are mild blood thinners

and all of them knock aspirin, a better blood thinner, off binding sites. So, in patients at risk for bleeding, you have an increased risk. In patients with a cardiac history, you have decreased antiplatelet activity of aspirin prescribed for that reason.

Drugs are targeted poisons. Taking them "just because" is always a bad idea.

I'm not surprised this study was halted. If you're taking the stuff for its antinflammatory properties for arthritis, please continue, it's really good for that. If you're taking it short term for things like sprains and strains, it's really good for those. If you're taking it because great Uncle Henry had Alzheimer's, don't bother. The risk of side effects are greater than your risk of disease.

Do crossword puzzles instead.

[Pirate Smile]

18. My Mom takes Aleve daily for arthritis. Thanks for the great information

[A Brand New World]

25. Warpy: I take Aleve once a day for cervical arthritis. You seem to know

alot about health issues. Should I continue with Aleve or should I contact my doctor? I just saw her last Friday and at that time she said continue with the once a day since my pain and inflammation are under control at that dosage. So now I'm scared to take it. Please tell me your qualifications.

[phasev]

53. pain relief

just smoke some pot...

If you have alzheimers or are at risk of alzheimers then perhaps you should be changing your lifestyle and your diet.

[Cyndee_Lou_Who]

2. It's spelled Aleve.... what are they saying about it?

Link??

[Hokie]

3. And???????????????

Just what might that warning be?

[Hokie]

4. OK. Thanks for the rest of the story (NT)

[blue sky at night]

5. Thanks for the info........

I have tennis elbow and if it flares up there is nothing like Naproxen to kick it. My Doctor had me on 1000mg twice a day for a while, but it sure works. I guess I am going to watch it if I take it OTC.

[Liberal Veteran]

6. I pulled a muscle in my leg and it worked like magic...I was taking 440mg.

....every 6 hours.

[Occulus]

33. I pulled a muscle in my back

and Naproxen did exactly dick for it. Nada. Nothing. Zilch. I noticed no relief.

Now I have two reasons to avoid it. I just hope the larger reason doesn't bite me in the ass later on down the line....

[wicket]

7. I take Naproxen

Better talk to my doctor about this!

[PDittie]

8. I've been taking it for years

though never in the dosage described as dangerous (I usually have taken one 220 mg tablet a couple of times a week).

The bottle just hit the trash. Nothing but aspirin for me from now on (yeah yeah, it's got its own warnings, I know; spare me).

[Danmel]

9. It's Great for Menstrual Cramps

I only use it for a few days a month- it is great for cramps- I hope that's OK- have to ask the Doc.

[Seeking Serenity]

29. It's great at reducing my flow.

I'm usually pretty heavy. Aleve lightens it up considerably.

:-)

[Ms_Mary]

43. My husband tossed ours out this morning too

I rarely ever take any kind of medicine at all and that would be the one kind of pain killer I'd have in the house. Go figure.

[don954]

10. Is there anything considered safe that works?

I have severe hip joint pain, and a combo of 2 Excedrin and 2 Naproxen every 4 hours are the only thing that helps it. None of the new prescription stuff even comes close.

[thecrow]

11. Let's see... no vioxx, no celebrex, no naproxen....

Just wtf are you supposed to take if you have chronic arthritis?

[benburch]

14. Opium is safe and effective...

But of course they will never allow that.

[Warpy]

17. Bingo

Opiates are the safest and most effective pain drugs out there. They don't have any anti inflammatory activity, which makes them poor choices for single therapy for inflammatory conditions, and some people will run into trouble with dependence or addiction. However, the drugs are relatively kind to body systems.

Just because a few folks abuse them, most of us are expected to either live in pain or risk our lives on drugs that don't work as well and are much more dangerous.

The DEA is the enemy of anyone who lies with pain.

[luaneryder]

20. I could not function

w/o narcotic pain relief and am allergic to anti inflammatories. I'm not continually high; I don't get that euphoria. You're right, the DEA would much rather see me and millions of other chronic pain sufferers "learn to live with it" rather than ensure we are receiving proper pain control. Physicians, scared shitless, have been upfront with me and said that the DEA was watching them to see how many narcotic scripts they write, so they don't.

[RobinA]

51. I Was Just Saying This

when I heard about Naproxen. Go straight to narcotics for pain relief. It won't kill you, you'll feel good, and you won't be in pain. You may become addicted....but that is managable with medical supervision. Beats a life of excruciating pain.

[dweller]

32. and you can grow it at home

can't have that now can we...


dp

[Jesus H. Christ]

45. Well, it's effective.

nt

[havocmom]

26. I am sticking with the Aleve. If my brain goes, maybe I won't notice

how bad the arthritic inflammation keeps getting despite meds. The point I am at, the chronic pain is so bad, death doesn't look so terrible.

[patdem]

12. I had a gall bladder attack that lasted about two weeks, took Aleve

as prescribed and filled up on asprin in between and ended up having a siezure two days before having my gall bladder removed. Could have been the combo? But since it messes with the brain, now I wonder. I have had one before and none since, and that was in January 2004.

[happynewyear]

13. non-steroidal anti-inflammatory drugs

These "NSAIDS" are all sort of drugs with different names - next, the great Motrin (aka ibuprofen).

I was taking stacks of Motrin for chronic pain and my blood pressure is quite high now. I cut the dosage way way down from about 2500 mg. a day to about 400 a day now.

I also am back taking aspirin, aspirin/codeine (again); old drugs that actually work.

Recent studies from the Nat'l Inst. for the Blind indicate that aspirin may prevent macular degeneration of the eyes from progressing interestingly enough.

It is very sad that these drugs might add to the risk of developing or even worsen Alzheimer's and also lead to cardiovascular events (aka heart attack/stroke; death ... just like Vioxx and Celebrex all over again!).

Damn the FDA! Rather late isn't it? Naproxen has been sold over the counter for a number of years; before the name "Aleve" came out it was an RX only drug.


:(

:dem: :kick:

[Lone_Star_Dem]

19. My first thought when I read this was, what about ibuprofen?

It falls into the "NSAIDS" category, also.

[happynewyear]

22. I bet ibuprofen will be next

I have a good knowledge of drugs being I used to work for a pharmacologist. These NSAIDs have only been studied for about the last 20 years or so. This is really not that long. When Motrin first came out they used to give out free "samples" of it where I worked (this was in the mid-1980s). It worked alright, very well in fact.

Hence, the patent expired and Motrin became the new over-the-counter miracle drug "ibuprofen" which is handed out and given to people like candy.

Its mighty rough on the gut and I always take it with food or milk. I still do take it, but no more 2400 mg. a day of it. The blood pressure thing has had me scared enough in my own particular case. :scared:

[FlaGranny]

36. I have always noticed that

if I take much ibuprofen my blood pressure increases. I only take it when absolutely necessary. It is the only pain killer that works for me and doesn't cause stomach distress.

I have found a substance that works wonders for me, especially for stiff muscles and joints - it is MSM (or methylsulphonylmethane, an organic sulfur). If you check it out with a google search it says it may take a while to kick in, but for me, I can usually see an improvement in a few hours and always by the next morning. I don't think it will work for pain from sprains, headaches, or pancreatitis, but it seems to be pretty good for sore, stiff muscles.

[ally_sc]

47. YEP..

I can see them pulling the ibuprofen now...I saw the handwriting on the wall about vioxx, and when they came out with the first negative press release i stopped it. same with the HRT. I guess maybe they will go back to the hydrocodone and oxycotin, lol...tried and true opium...

[Pathwalker]

49. That's what a Doctor told me this morning!

But, still advised me to take that instead of the Naprosyn. Go figure.

[Trajan]

15. Ive taken Aleve TWICE in my life ...

[koopie57]

21. I've taken aleve once in my life

and swelled up like a Macy's Thanksgiving Day Parade balloon.

[NNN0LHI]

23. Sonuvabitch. Naproxen is the only non-narcotic that helps my back pain

Had back surgery some years ago and the Naproxen has been the only thing that has consistently worked for me when I have needed something for pain relief. This ain't no good. Shit.

Don

[Princess Turandot]

24. It seems a bit odd to me..

that the FDA issued a warning about naproxen within days of a scientific study finding that a major prescription product line for Pfizer, Celebrex (an anti-inflammatory med from a different class of drugs) caused a increased risk of heart attacks in the patients in their study. (That study was looking at the impact of Celebrex on cancer and I believe took place at a university research center. The increased rate of heart attacks caused the researchers to stop the original study & report their findings publically.)

One of the suggestions by MDs was to use the OTC NSAIDs, such as naproxen, in lieu of Celebrex. The FDA has yet to have a formal reaction to the Celebrex findings, although they are debating whether to require stronger warnings on the drug, or perhaps take it off of the market altogether. A drug similar to Celebrex, Vioxx, was taken off the market this year because of the risk of increased heart attacks.

I guess one difference is that the intake of naproxen does not require an MD's involvement, while Celebrex does.

Even tylenol can kill you, since it reacts with alcohol badly and has actually caused fatal liver failure in a few people who took it while consuming alcohol.

[Bush was AWOL]

27. I take Aleve everyday

:-(

[cmd]

28. It helps with my arthritis

I can't take many medications, but Aleve has been a blessing when the pain takes over my life. I'll continue taking it when absolutely needed.

[Gloria]

30. Post back surgery, I was stumped....The large doses of Ibuprofen

are known to react with another medication I've taken for years, so I had to stop as soon as possible. Vioxx made me sick, Bextra same, Celebrex worked amazingly well for about a week, then did nothing so I stopped. I took Naproxen a few times, but found it wasn't very effective.

So, I turned to aspirin. Two on the mornings I really need it and I'm set for the day.

Good old aspirin.

[PDittie]

35. Big Pharma really regrets that they didn't do with aspirin

what they have done with every other drug that was effective; mark the price up ten times and make it available by prescription only

[KoKo]

31. Doesn't the article say it's only a problem if you take MORE than the

recommended dose, though? Since it's been around since 1976...most problems should have shown up by now...unless folks get overconfident and take more than the recommended dosage? :shrug:

[AnnitaR]

34. Question

What was the study about? Were they thinking that drugs like Naproxin help reduce the risk of developing Alzheimer's?

My mom has short term memory problems due to stroke. She is taking Aricept now which is supposed to be for Alzheimer's patients but they say helps patients with short term memory problems as well. They have assured us that her memory problems are due to the stroke and she shows no signs of Alzheimer's but I am still scared to death about it.

She takes Naproxin daily for her chronic shoulder pain (due to a fall). She does however have a family history of heart problems. She had some tests done some time ago and they showed that she had had a small heart attack at some point. She wasn't hospitalized and really doesn't know when it could have happened.

This constant Catch 22 we have to play regarding medication is getting ridiculous! It seems like every week we are hearing new warnings and advisories. The balancing act is getting harder and harder. Looks like I will be calling her doctor today.

[FlaGranny]

37. I've always done my best to stay

away from doctors. I only go when absolutely necessary. Some elderly people are on 20 and more different drugs. It absolutely can't be good to be taking that many. Some doctors deserve to be called "pill pushers." I remember a few doctors (before I retired) who could be counted on to supply every single one of their patients with multitudes of drugs. I think the patients who really get overdrugged are elderly diabetics. The diabetes starts affecting every organ in their body and they wind up with a different medication for every body organ, and then a handful of meds to counter the bad effects of some of the other meds. I never could make up my mind whether all those meds were helping or killing the patients.

[Walt Starr]

38. Bummer, I've taken it twice per day for several months before

I have chronic foot pain and Aleve always relieved it well enough for me to function. Never exceeded twice daily, but took it taht way for several months at a time.

[Oilwellian]

39. I used to take Aleve

I have arthritis in my hip due to an old gymnastics injury...the Aleve was giving me heart palpitations so stopped using it. Now I drink Willowbark Tea when the inflamation flares up...no more pain. :D

[Pathwalker]

40. Let's see; 500mg, 2x daily for TWENTY years - I am SO

screwed! I suppose I should be glad I haven't already died from this stuff. :mad:

[Walt Starr]

42. We need to see if there's anything class action going on

You and I are in similar boats, except I haven't taken it for as long as you.

[Pathwalker]

46. Well,I intend to join THAT class-action suit when it

comes, and I hope you do too, Walt! I called my Doctor's office this morning; my Dr. is on an extended vacation, so the Dr. on call advised: Take maximum amount of Acetamenaphen for 7 - 10 days, then start on Ibuprophen - UNTIL IT'S RECALLED!!! She said it will be the next to go, but don't worry, go ahead and take that until it is recalled!
If I have problems with it - go to the emergency room! WTF!!!

[happynewyear]

52. jesus crippers!

Wow, I'd be pissed too! Wait until IBUPROFEN is recalled! Hell! I've been taking it too for a long time for chronic severe pain as well as osteoarthritis.

Luckily, I tended to like aspirin/codeine the best luckily for many years but they kept shoving bottles of Motrin at me so I wouldn't get "hooked" on narcotics. But then, they gave me Vicoprofen which is like taking one Vicodin EX plus 200 mg. ibuprofen! It just went off patent - used to cost a bundle but now they coveniently have a generic form available. Yeah, it works pretty good alright, but now I'm having all of these other "problems" that I never had before, one being a risk of a heart attack or a stroke I was told JUST LAST WEEK! :grr:

I'll be joining that class action lawsuit myself! Damn these pill pushing greedy doctors and drug companies!

Once "Motrin" (aka ibuprofen) is revealed, the lawsuit will be big enough to topple the damn evil and greedy pharmaceutical industry and believe me, IMO they NEED TO BE TOPPLED and I do believe I have the background to fully support this statement. :grr:

[Straight Shooter]

41. I take Orudis (ketaprofen), never wanted to take Aleve (don't ask why)

Something about Aleve bothered me, never wanted to take it, although I've had people recommend it to me.

OTOH, I've recommended Orudis to former Aleve-takers, and they have switched. AFAIC, no other over-the-counter med is as good for relieving minor aches, strains and sprains, and headache.

I learned about ketaprofen from my vet, because they use it for animals who are injured, but of course the dosage is higher for an injured animal than a nonserious pain in a human.

No drug should be taken long-term without a doctor's oversight. You just never know how your individual body is reacting and shouldn't take anything for granted.

[captain disgruntled]

50. I'm no physician, but here's what I got from the article:

Aleve was being tested for efficacy in preventing the development of Alzheimer's in people regarded as at risk. The test was halted because some patients coincidentally showed more risk of "cardiovascular events" than patients taking placebos.

Even aspirin, our happy old-school standby, first synthesized from willow parts, can reduce blood-clotting--this is a happy thing for those at risk of stroke, but can be enough to delay emergency surgery for fear of increased bleeding, and long-term use of aspirin can also damage the lining of the stomach.

As Straight Shooter points out, an important component of any medical regimen is the individual patient's specific response to chemicals. We all know people with unusual pain thresholds or life-threatening allergies to common drugs/antibiotics/whatever. The point is, you need to respect the individual's responses to drugs.

Very few medications, even herbal preparations, are recommended for long-term use or at high dosages. If you are not otherwise at risk for heart crises and Aleve is a medication that you know is effective for you for pain/inflammation, then there's probably no reason to freak out about taking it for a couple of days a month or if you sprain your ankle.

Stop as soon as you can, and try some other treatments--heat, ice, exercise, chiropractic manipulation, etc.

[tiredofthisstuff]

44. Cough Cough- Was that my lung I just spit out?

It seems to me that in the last year more and more drugs (Perscription & Over the Counter)have been brought into question. To me the big question is "What the f*** are these drug companies doing. It isn't bad enough that we have to watch the drug company's stupid ass commercials. Now our health is put into jeopardy by these under tested products that the drug companies assure us are safe. What ever happened to drinking hot tea when we caught a little cold? Now we have to worry about a possible heart attack for taking a pain reliever.

[7th Generation VTer]

48. Pill pushers!

I'm damn sick of pill pushers!!!! :grr:

Not that I go to them; I have no insurance and so can't afford to. But my elderly parents naturally have assorted health problems (mostly minor, thank the goddess). Over the past two years, my dad's gone through a lot of agony because of pill pushers. In Feb. '03 he twisted his back and was in total, total agony with a severely pinched nerve. I took him to the doctor; they took X-rays, gave him a powerful narcotic and said for him to walk with a cane and come back in 2 weeks for more narcotics. Not only did the pills do nothing for the CAUSE of the pain, they screwed up his digestion, made him sick and constipated, and knocked him out. The next day my sister and I took him to a chiropractor, who began an intense course of spinal adjustments and gave him a homoepathic anti-inflammatory (Traumeel). Within 2 weeks Dad was hauling firewood and shoveling snow; within 6 months his spine was back where it should be (allowing for age, of course). Had he stuck to the mainstream medicine he would have been paralyzed with pain and bedridden, and subjected to monstrously expensive surgery.

This past summer Dad's knee began to hurt and swell up. The Dr. at the clinic gave him a whopping dose of naproxen (1600 mg daily). Within a few days the knee was better, but he began to bleed internally and had fluid accumulation in his lungs. He quit taking the stuff, and now tends his sore knee with warming ointments (Bengay, Icy Hot, etc.). The literature that came with the Naproxen said that blood loss of no more than half a cup a day was acceptable. SInce WHEN is ANY blood loss as a side effect acceptable?

As for me, I take ibuprofen for headaches and cramps, and Traumeel for muscle and joint aches and pains. I don't take anything else.