Vioxx users...

[greg c]

Haven't seen this on the board, but it is a relevant and evolving situation- for the whole class of medications.

http://content.nejm.org/cgi/content/abstract/NEJMp048286

http://content.nejm.org/cgi/content/abstract/NEJMp048288

[Team Sergeant]

Haven't seen this on the board, but it is a relevant and evolving situation- for the whole class of medications.

http://content.nejm.org/cgi/content/abstract/NEJMp048286

http://content.nejm.org/cgi/content/abstract/NEJMp048288

It might be evolving to you but for me it's over.....

Vioxx has been removed from the market.

Team Sergeant
former Poster Boy for Vioxx.....

[The Reaper]

It might be evolving to you but for me it's over.....

Vioxx has been removed from the market.

Team Sergeant
former Poster Boy for Vioxx.....

Yo tambien, and after reading that, I am considering alternatives for the Celebrex they gave me to replace it.

It was nice to take one low dose, low stomach upset pill, once daily, but looks like there are good reasons not to use any of the COX2 inhibitors now.

I may be back to burning holes in my stomach with Ibuprofen and using narcotics when it gets really bad.

Bummer.

TR

[Team Sergeant]

celebrex and vioxx have the same basic mechanism of action and it is now being questioned whether the other two cox-2 inhibitors (celebrex and bextra) will have the same side effect if the studies are done to assess for this. Studies necessary to pass FDA approval don't typically have the patient numbers to bear out certain side effects... it was a study looking at vioxx for decreasing the incidence of colonic polyps that began to show an increased incidence in cardiac/cerebral events...

I would be cautious about using the drugs until further testing occurs... if it occurs.

doc t.

TR I asked Doc T to address this when I saw your post... as I saw you're in the same situation I currently in.... and I'm back on motrin....

TS

[Roguish Lawyer]

Doc T:

Isn't it possible to take something to control the impact on the stomach from taking ibuprofen constantly, like prilosec or whatever?

:munchin

[NousDefionsDoc]

Damn! So much material here I don't know where to start. :p

[CPTAUSRET]

I also was on Celebrex, and was just switched to Etodolac, then to Pyroxicam. I used to be on 800 mg Ibuprofen 4 times per day.

Terry

[Roguish Lawyer]

I used to be on 800 mg Ibuprofen 4 times per day.

WOW

[now this post is more than 10 &*^%*&^%*&^% characters]

[swatsurgeon]

Gents,
the vioxx issue has been there for over 2 years and finally a second study was done , for another reason, and the same 'bad' effects were noted. The big conference given by Capt. Frank Butler for the Tactical Combat Casualty Care has Vioxx as the preferred in theater oral med for pain control. As a heavy user of Cox-2 drugs, I use Bextra 20-40 mg for the same purpose as Vioxx (I have never prescribed Vioxx due to all thatI had learned about it...sorry TS, it's a dangerous drug, now verified. Bextra, like Celebrex has a significantly reduced incidence of stomach side effects (gastritis, ulcers, bleeding) and does NOT interfere with platelet function so that your blood will clot normally.

[Doc T]

I am not sure that celebrex has been shown to not increase risks...I need to review the data cited in this article but they say the retrospective review of the year of data rather than 6 months of data does show a trend towards increased cardiovascular risk... not statistically significant from what it implies but certainly could be a concern...


I would stay tuned and avoid them unless you have known GI intolerance with bleeding or very low CV risk...my two cents. Team Sergeant is back on motrin....

t.

[swatsurgeon]

motrin....... put him on Bextra, actually don't, I love operating on bleeding stomachs !!!!!!!
JUST KIDDING TS!! Doc T would kill me if anything happened to him!!
Agree with the need for further studies across the class but so far in any study I've read, no statistical significant increase in CV problems.
T-2

[ccrn]

Isn't it possible to take something to control the impact on the stomach from taking ibuprofen constantly, like prilosec or whatever?

:munchin


Nonsteroidal anti-inflammatory drugs (NSAID) are prostaglandin inhibitors. Prostaglandin is formed when cells are damaged. An enzyme breaks down lipids in the cell wall and converts them to an acid. This is further broken down by the enzyme cylcooxygenase forming prostaglandin.

Prostaglandin lowers the threshold of nociceptive fibers so that stimuli is painful. NSAIDS prevent prostaglandin production by blocking cyclooxygenase.

Its more complicated than that but thats the gist of it.

Prostaglandin is also responsible for maintenance of the gastric mucosa. Blocking the actions of prostaglandin can lead to GI bleed, decreased platelet aggregation etc etc.

I havent personaly heard of any way to prevent it from MD's I know. One can take NSAIDs with food but that decreases absorption. I know in the ICU we put everyone on zantac right away d/t stress etc. I would bet someone has done studies of chronic NSAID use concurrent with a proton pump inhibitor (prilosec) or
H2 histamine receptor antagonist (zantac).

Sorry that isnt of any help-

[ccrn]

I found this med while floating over to a step down unit today.

Misoprostol(Cytotec):

Indication: To prevent NSAID-induced gastric ulcer in elderly or debiltated patients at high risk for complications from gastric ulcer and in patients wtih hx of NSAID induced ulcer.

Dose: 100-200microgram

Action: A synthetic prostaglandin E analogue that replaces gastric prostaglandins depleted by NSAID therapy. Also decreases basal and stimulated gastric secretion and may increase gastric mucus and bicarbonate production.

I dont know much about this drug other than it was part of a combination drug (Arthrotec) that incuded a Cox1-2 inhibitor. Also the pt it was prescribed to is 17 yrs old.

From what Ive read it is available as a stand alone med.


The Docs will have something to say about this Im sure-

[rogerabn]

Well CCRN, glad they floated you. I was in a pain mangment meeting, we have a pt. with chronic hip pain, but is also a major narcotic drug seeker. So... we implemented a round the clock NSAID, COX ll inhibiters, and Cytotec. No one had used Cytotec, but all attending felt it would be very appropriate for the case. Thanks for a good tip.

[ccrn]

YVW Sir,

From what Ive read the med has been controversial as an abortion pill and misused to induce labor-

[Galadriel]

Please don't take this the wrong way, but would any of you consider using marijuana for your pain management? My grandmother had a laundry list of ailments towards the end of her life and tried many alternative medicines, marijauna being one of them. It did help her.
I think they do have some medicinal marijauna now that doesn't effect you psychologically (you don't get "high"). Something to consider. It seems that most medicines for pain management just cause more harm than good.

[Sacamuelas]

No

The Rx drug is called Marinol. It is a synthetic form of THC which is only one of the many chemical ingredients in marijuana. It is NOT used for pain management. It is FDA approved to treat anorexia and nausea/vomiting associated with AIDS/HIV Treatments or chemotherapy treatments. Although I didn't write it myself- I have a few patients that take it, and it seems to work well for them.

[Galadriel]

Thanks Senor Dentist!
Hmmm, guess that rules out some options. Besides, I didn't think marijauna really helped with pain, just the symptoms you just mentioned (plus cataracts).
There are several homeopathic remedies that are used to treat arthritis and pain, ie. burdock, wormwood, black elder, etc... in conjunction with acupuncture. I'd sure as hell seek out these alternatives first than put up with bleeding ulcers and liver sclerosis. Something to consider. You have only one body; its worth investing in.

[Peregrino]

Just got back on line after being OOTL for a while. Saw the Viox thread and couldn't resist passing on my own experiences. I recently (18 months ago) had a heart attack. Not something a 44 y/o male in reasonably good shape expects - in fact it happened while running PT (I'll never do that again - always thought it could kill you, now I know it can!). While at UNC Chapel Hill being treated for it the attending CC Nurse ran through the usual patient questionaire and when we got to drugs she expressed a very negative reaction to the fact that I was on Viox and had been for about three months prior to the MI. At the advise of the attending Cardiac Team I immediately quit taking the Viox. Apparently the cardiac community has known/suspected something like this for quite some time. Like most of us I was prescribed Viox for the usual aches & pains as an alternative to the 800mg Ibuprofen. No, it didn't eat holes in my stomach but now I'm wondering what else it might have done/contributed to. At the time it was the drug of choice in the Bragg medical community for long term relief of "arthritic" symptoms. Personally I'm back to living with it and escalating through Motrin, Naprosyn, and Tramadol on the bad days. I'm sure most of us will agree winter/bad weather just isn't much fun anymore. :( FWIW, Peregrino

[Shark Bait]

Man, I was going to try Viox for my back. My stepmother has used it and said it worked great. I have heard a little about problems with it. I'm glad there's more info here.

[lrd]

Great thread. Great information. My mother was put on Vioxx for her hips because the Motrin was killing her stomach. The only reason this caught my eye is because she recently complained about Vioxx being taken off of the market. Now I can tell her why.

Update: I talked to Mom. Before her hip replacements she was taking Motrin, but that really messed up her stomach. After surgery, they originally gave her Celebrex which worked for a while, but then stopped. Then they put her on Vioxx which was great for the pain. She didn't realize it was causing her to retain fluid until she stopped taking it: she lost 4-5 pounds in the first two days after she quit the Vioxx. Then she was on Bextra, which didn't work at all (but my cousin swears by it). Now Mom is taking Arthritis Strength Tylenol in the morning for the pain, and Aleve (naproxen) at night for the swelling. Doesn't work as well as the Vioxx, but she said she'd rather live with the pain than worry about the side affects.

[Jo Sul]

http://www.cnn.com/2004/HEALTH/conditions/11/11/arthritis.drugs.ap/index.html

[Roguish Lawyer]

http://www.cnn.com/2005/HEALTH/conditions/02/18/arthritis.drugs.ap/index.html

FDA panel: Keep Vioxx, Celebrex, Bextra on market
Advisory group says there are risks but benefits outweigh them
Friday, February 18, 2005 Posted: 3:55 PM EST (2055 GMT)

WASHINGTON (AP) -- The popular painkillers Celebrex, Bextra and Vioxx all pose a risk of heart trouble, but should be available to those who need them, advisers to the Food and Drug Administration said Friday.

The panel strongly favored keeping Celebrex on the market, split over Bextra and favored Vioxx -- which is currently not on sale -- by a vote of just 17-16.

"The data is very compelling," Vioxx is substantially worse than the others, meeting chairman Alistair J.J. Wood of Vanderbilt University School of Medicine said.

The panelists voted 31-1 to keep Celebrex on sale and, after a revote, favored Bextra 17-13 with two abstaining.

The FDA is not required to follow the recommendations of the panel, but generally does so.

At the opening of the three-day meeting, FDA officials promised a prompt response to the panel's suggestions, which it requested after studies began showing problems with the drugs.

The panelists were unanimous in saying the drugs, known as Cox-2 inhibitors, pose risks of heart trouble. Studies of Bextra were limited, but showed a greater risk than Celebrex, the committee noted.

The advisers suggested restrictions on the drugs such as placing a severe "black box" warning on them, including more patient information with the drugs, restricting which patients could get the drugs and possibly banning direct-to-consumer advertising for the products.

Meeting Chairman Alistair J.J. Wood of Vanderbilt University Medical School said it is important to find some way to help the public better understand the nature of risk.

"People worry about crime and then drive drunk," he said, indicating they don't really understand relative risks.

Dr. Steven Nissen, medical director of the heart center at the Cleveland Clinic said "What we really want is to make sure it's available for patients that need it and is unavailable to patients who whom it's inappropriate."

The FDA's arthritis and drug safety advisory committees, concluding three days of meetings to assess the risks of three popular painkillers called Cox-2 inhibitors, were to address Vioxx and Bextra later in the day. All three drugs have been approved for sale by the government.

The advisers also were set to frame recommendations to the FDA about whether further testing is needed for the drugs and any special warnings or limits placed on them.

"We need to find the unique patients that will benefit from this drug and work out what they need to be told," said Wood.

The committees were asked to assess the drugs after Merck & Co. pulled Vioxx from the market last fall because of health concerns. Since then questions have been raised about Bextra and Celebrex, both made by Pfizer Inc.

The excess risk from Celebrex varied in different studies and the panel didn't seek to determine just how much more hazard a user faces than someone on another drug.

However, the panel was told that no cardiovascular problems were seen at the normal prescription dose of 200 milligrams. Heart trouble began to appear in colon polyp study patients who took 400 milligrams.

Merck stock shot up nearly 12 percent in the minutes following the announcement, increasing $3.35 to $32.20 per share in afternoon trading on the New York Stock Exchange. Pfizer shares rose $1.39, or 5.6 percent, to $26.45 on the NYSE.

Earlier in the meeting, Wood said the safety problems reported in connection with Cox-2 inhibitors exceed those of products that have been withdrawn from the market.

However, since the side effect involving heart attacks, irregular heartbeat and stroke is a relatively common problem, that makes it harder to pin it to the drugs than if it were a rare side effect.

Dr. Peter S. Kim, president of Merck Research Laboratories, had told the FDA committees earlier that new studies indicated the side effects aren't unique to its product.

"There are unique benefits to Vioxx," he said. "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 noted that Vioxx seemed to have more such reports than the other drugs.

On the other hand, Kim said, 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.

Dr. Robert Temple, director of medical policy for the FDA's Center for Drug Evaluation and Research, told the committees on Friday that "the idea of doing a large new study has weight."

"There are some data we'd all like to have, that we don't have," Temple said, including the blood pressure and other effects of the various drugs.

He said a new study might include more than just the Cox-2 drugs, possibly adding such widely used painkillers as ibuprofen, naproxen and diclofenac.

"My main point is that there is a very important need for more information on many of these drugs," Temple said.