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Vioxx To Return?

Medicine Vioxx 2005

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#1 Vapor Trails

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Posted 18 February 2005 - 10:46 AM

Painkiller Vioxx Might Return to Sale

Quote

WASHINGTON - The painkiller Vioxx, pulled from the market last fall because of reported heart problems and strokes in users, could come back on sale if federal regulators conclude it and similar drugs have benefits that balance the risks.

Dr. Peter S. Kim, president of Merck Research Laboratories, told a joint meeting of two Food and Drug Administration (news - web sites) advisory committees on Thursday that new studies indicate the side effects aren't unique to its product.

The advisory panels were concluding a three-day meeting Friday in which they have been assessing drugs known as Cox-2 inhibitors, which also include Pfizer Inc.'s Celebrex and Bextra, to determine whether they are all risky and, if so, whether they have balancing benefits.

All three drugs have been approved for sale by the government. The committees' recommendations could be the first steps toward rescinding those approvals.

Meeting chairman Alistair J.J. Wood of Vanderbilt University Medical School asked whether the drugs could win approval today, considering the studies that have come to light in recent months.

Kim indicated a positive assessment by the committees might lead Merck to consider bringing Vioxx back onto the market.

If the committees and the FDA (news - web sites) conclude that the benefits of this class of drugs outweigh the risks for some patients, "then we would have to consider the implications of these new data" for Vioxx, Kim said.

Asked if he meant the company would consider returning Vioxx to the market, Kim said: "There are unique benefits to Vioxx. The science has progressed and we need to take that science into consideration."

While the committees heard evidence that all drugs in the group can increase the risk of heart attacks, irregular heart beat and strokes, it did note that Vioxx seemed to have more such reports than the other drugs.

On the other hand, Kim pointed out that Vioxx is the only one of the drugs approved for people with certain allergies and did better at preventing the stomach and intestinal problems often caused by over-the-counter painkillers.

:wacko:  :blink:  :wacko:  :whatsthat:  :wacko:  :glare:

Being the son of a parent with severe arthritis and heart problems, this crap drives me f*****g NUTS.  :angry:

If I give my mom a pill, it might do some serious harm to her. If I don't she'll suffer, anyway.  :glare:

I know, I know-stop whining Saul, and face reality. Everyone gets old, and them's the breaks. Been there, done that with my father-who's been dead now 3 years.

But it doesn't get any easier.

:pout:
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#2 Godeskian

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Posted 18 February 2005 - 11:11 AM

I'll bet not.

And somehow the notion of a pill which is labelled 'Sideffects: may cause your heart to go splat' isn't very reassuring.

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#3 Vapor Trails

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Posted 18 February 2005 - 06:06 PM

Steven_Q, on Feb 18 2005, 11:11 AM, said:

I'll bet not.

And somehow the notion of a pill which is labelled 'Sideffects: may cause your heart to go splat' isn't very reassuring.

<{POST_SNAPBACK}>


Uh-huh.  :sarcasm:

"Well, you might lose your right lung forever if you take these pills, but hey! At least you have your left lung!"

Thoughts like that keep me warm at night.

NOT.


:wacko:  :glare:  :sarcasm:  :wacko:

Edited by Digital Man, 18 February 2005 - 06:07 PM.

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Politicians are like bananas; they hang together, they're all yellow, and there's not a straight one among them.

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#4 Peridot

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Posted 19 February 2005 - 12:12 AM

Vioxx? :oh:

Peridot looks rather floored...

Good Heavens.   I used to take that stuff, a couple of years ago....


.....I always though it was....well....a little strange... :Oo:


Thank you for posting this, Saul.

Peridot

#5 Psyche

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Posted 19 February 2005 - 01:02 AM

I used to take Vioxx for a back injury. Won't take it anymore though.

#6 Chakotay

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Posted 19 February 2005 - 09:20 AM

If you've no existing heart trouble, it's probably safe.

People with heart problems take other types of pain killer.

No drug company is going to watch all that research cost go down the pan without trying to find some market for the product. Too many mega-billions of profit at risk.
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#7 Vapor Trails

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Posted 19 February 2005 - 11:59 AM

Peridot, on Feb 19 2005, 12:12 AM, said:

Vioxx? :oh:

Peridot looks rather floored...

Good Heavens.   I used to take that stuff, a couple of years ago....


.....I always though it was....well....a little strange... :Oo:


Thank you for posting this, Saul.

Peridot

<{POST_SNAPBACK}>


Wow-you mean you haven't been following the news on Vioxx??  :eek:  :blink:  :eek:  :blink: That's been all over the news!!  :Oo:

Hmmm-I gotta find that thread I started that was pinned. Dunno if it's in EU. I'll see about finding some other links for you.

:cool:
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#8 Vapor Trails

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Posted 19 February 2005 - 12:12 PM

I PMed you and bumped up my old Vioxx thread in EU. :)

Good luck!!

:cool:

Edited by Digital Man, 19 February 2005 - 12:13 PM.

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#9 Vapor Trails

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Posted 19 February 2005 - 12:17 PM

Chakotay, on Feb 19 2005, 09:20 AM, said:

No drug company is going to watch all that research cost go down the pan without trying to find some market for the product. Too many mega-billions of profit at risk.

<{POST_SNAPBACK}>


That's some situation to be in: either make mega-billions in profit or face mega-billions in lawsuits.  :blink:

Sheesh!!  :wacko:

There are few situations more FUBAR than that.  :eek4:  :crazy:  :Oo:
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Politicians are like bananas; they hang together, they're all yellow, and there's not a straight one among them.

"We're relevant for $ and a vote once every two years. Beyond that, we're completely irrelevant, except of course to consume, and preach the gospel according to [insert political demigod here]."--Cait

#10 Lord of the Sword

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Posted 19 February 2005 - 12:43 PM

Digital Man, on Feb 18 2005, 10:46 AM, said:

:wacko:  :blink:  :wacko:  :whatsthat:  :wacko:  :glare:

Being the son of a parent with severe arthritis and heart problems, this crap drives me f*****g NUTS.  :angry:

If I give my mom a pill, it might do some serious harm to her. If I don't she'll suffer, anyway.  :glare:

I know, I know-stop whining Saul, and face reality. Everyone gets old, and them's the breaks. Been there, done that with my father-who's been dead now 3 years.

But it doesn't get any easier.

:pout:

<{POST_SNAPBACK}>


I feel for you. A similar situation arose with my Grandfather. He was in the hospital, in extreme agony due to cancer. The doctors couldn't control his pain and told me and my Aunt that since they weren't able to get his pain under control there, they were going to give him some pain pills and send him home.

You can imagine what my response to that was...
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#11 Vapor Trails

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Posted 19 February 2005 - 01:18 PM

^

:pout: !!!!!

I'm TERRIBLY sorry to hear that, LoTS.

:(
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#12 mjtian

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Posted 19 February 2005 - 05:14 PM

Digital Man,

          I am sorry to hear your situation.  Unfortunately, Pain Management is one of the most difficult tasks in medicine.  As you are probably aware of the 0-10 pain scale, it is just impossible to consistently and accurately to monitor pain today.  

         Have your mother tried physical therapy?  I understand your concerns with regard to your mother's heart condition and arthritis.  Unfortunately as we all age, arthritis is inevitable.  If we live long enough, one day we will all need knee and hip replacements.  Her heart makes it even more difficult to manage her pain, especially with the new studies ont he COX II meds.  I do not know her current medical conditions and I am sure you have much better qualified people taking care of her than myself.  I would highly recommend PT at this point, but is she is unable to tolerate that, depending on her other conditions, I may consider some other forms of alternative medicine such as Chinese Acupuncture to help alleviate the pain.  I would not use the alternative medicine as my only source however, but studies have shown that if we combine allopathic medicine with the alternative medicine we can acheive better results.  Hopefully, this can lessen her dependence on the pain meds and the lower doses can lessen her cardiac risks.

Edited by mjtian, 19 February 2005 - 05:18 PM.

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#13 Peridot

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Posted 20 February 2005 - 01:45 AM

Digital Man, on Feb 19 2005, 05:59 PM, said:

Peridot, on Feb 19 2005, 12:12 AM, said:

Vioxx? :oh:

Peridot looks rather floored...

Good Heavens.   I used to take that stuff, a couple of years ago....


.....I always though it was....well....a little strange... :Oo:


Thank you for posting this, Saul.

Peridot

<{POST_SNAPBACK}>


Wow-you mean you haven't been following the news on Vioxx??  :eek:  :blink:  :eek:  :blink: That's been all over the news!!  :Oo:

<{POST_SNAPBACK}>


No, we had a lot going on last fall :unsure: .....so I probably either didn't notice any articles on Yahoo, which is where I often get my news, or I might have just plain missed them altogether.


Digital Man, on Feb 19 2005, 06:12 PM, said:

I PMed you and bumped up my old Vioxx thread in EU. :)

Good luck!!

:cool:

<{POST_SNAPBACK}>


Thanks, Saul! :)

I went and read the thread, and a couple of the links in it; one link was no longer active (or whatever they call it) but the others were still there and the one by the Washington Post was particularly informative.

It looks like I wouldn't be likely to have any serious negative effects from taking it, because I only took it for something like three or four months, maybe five.  And I think it was a fairly low dose level.  But I'm going to look for more info on it, just the same.   :oh:

One other thing I'm going to do is let my family medical practioner know about my own experiences with Vioxx; I had some slightly odd physiological responses to taking it, which is one of the reasons I stopped.

What gets me is that I don't think I really needed the med in the first place.... :sarcasm: .....so now I have *two* stories of  medical personnel giving me a drug that wasn't good for me because they thought I needed more pain relief than I really did.... :eh:

Saul, I hope your mom's doctors are able to find something that is both safe and effective for her to take.  And as mjtian said, maybe physical therapy would make a difference for her, and with much less risk, as far as I know.

Sending positive thoughts her way, in any case.....she's a good lady who has done a lot to help other people.

{{{{{{{{{{{{{{{{Saul's Mom}}}}}}}}}}}}}}}}}}

Peridot

#14 Rhea

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Posted 22 February 2005 - 02:42 PM

Chakotay, on Feb 19 2005, 06:20 AM, said:

If you've no existing heart trouble, it's probably safe.

People with heart problems take other types of pain killer.

No drug company is going to watch all that research cost go down the pan without trying to find some market for the product. Too many mega-billions of profit at risk.

<{POST_SNAPBACK}>


Please note that Vioxx is NOT a pain killer, it's an anti-inflammatory. Not quite the same thing.
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#15 Vapor Trails

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Posted 22 February 2005 - 06:44 PM

mjtian,

Sorry I didn't respond sooner-I've been working on a story for publication. Thanks for the good wishes. :)

I'm looking into finding a specialist for my mom.

:cool:
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#16 mjtian

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Posted 22 February 2005 - 11:45 PM

Vioxx is indeed classified as a "NSAID" or non-steroidal anti-inflammatory drug.  However, its main function or mechanism of action is not for anti-inflammation.  Please don't read it too literally.  NSAIDS include many drugs including Asprin and Tylenol.  Vioxx is one of the NEWEST additions to the NSAIDS family of drugs.  

This class is called COX II which included Bextra and Celebrex.  Their main function is to block pain.  Actually Vioxx is no better at blocking pain than the over-the-counter Motrin, but the advantage of these newer drugs is that they are easier on the G.I system so there is decreased incidence of Gastro Intestinal Bleeding.  Especially if you are dealing with chronic pain, where the dosage and duration of medication are both greater.   This is a big deal, G.I bleeding is the #2 cause of Anemia in Males, secondary to only trauma I believe and I think it is #3 in females.  So from the G.I. perspective, COX II are very important.  I am sure this is the reason that FDA panel voted the way they did.  

Please keep in mind that even though the odds of Cardiac problems "doubled" this is still a relatively small % of the population.  In addition, the Bextra study involved extremely high doses to Cancer patients which does NOT represent the general population as a whole.  I sympathisize with the families that have dealt with loss, but remember that heart attacks are caused by many factors, the medication alone is unlikely to cause a cardiac event by itself.  Lets put it this way, I would not hesitate to prescribe Bextra or Celebrex to my grandfather if he need it and he had triple bypass 12 years ago.  I am sick and tired of the trial lawyers trying to profit from this and pass the cost onto consumers like you and I.
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