View Full Version : Vioxx harmful even after patients stopped taking it

12-14-10, 05:49 PM
By Frederik Joelving
Mon Dec 13, 2010

NEW YORK (Reuters Health) - Merck's withdrawn painkiller Vioxx may have continued to cause blood clots and perhaps deaths even after patients dropped it, U.S. researchers said Monday.

The drug was recalled by Merck in 2004 after a colon-polyp prevention study showed it increased the risk of heart disease and death in users. But over the five years it was on the market, researchers estimate it caused nearly 40,000 deaths. The new findings, published in the Archives of Internal Medicine, are based on data made available by Merck during multibillion-dollar litigation against the company. They show patients taking Vioxx (also called rofecoxib) doubled their chances of having blood clots or dying in the first half-year after discontinuing treatment, confirming earlier results that hinted the effects might last up to one year.

What happens after that is still an open question, said Dr. Joseph Ross of the Yale School of Medicine in New Haven, who worked on the study. "At this point, there isn't evidence to suggest that patients need to discuss with their physicians whether they are at increased risk after discontinuing Vioxx more than 6 years ago," he said in an e-mail to Reuters Health.

His co-author Dr. Harlan Krumholz, also of Yale, said the study also stokes concerns about painkillers in the same class as Vioxx -- the so-called selective COX-2 inhibitors. When scientists first discovered these drugs, the hope was they would lower the risk of ulcers among chronic users of non-steroidal anti-inflammatory drugs, or NSAIDS, such as people with rheumatoid arthritis.
But most COX-2 inhibitors -- a subset of the NSAID category -- ran into safety issues a few years after their approval, and now only Pfizer's Celebrex (celecoxib) remains on the U.S. market. Other NSAIDs include low-dose naproxen, ibuprofen, ketoprofen and aspirin.

In the new study, the team looked at 617 patients who had stopped taking either Vioxx or a dummy pill following more than a year and a half of use. After six months, on average, 22 patients on Vioxx reportedly developed blood clots and 23 died. Among those taking the placebo, the numbers were six and nine, respectively, at four months. That translates into an overall rate of deaths or blood clots of 0.11 per year after a patient drops Vioxx -- twice as high as seen in the placebo group.

"It indicates a need for more research to understand better how these drugs confer risk," Krumholz said in an e-mail, "and whether we need to know whether people have ever taken these types of medications when we assess risk." "For future drug evaluation and development we need to pay attention to effects that may manifest after the drug has been discontinued," he added. "To me, these results from the Vioxx studies about what happened to people after they stopped taking the drug may even be more important than the studies that showed risk when they were on the drug."

Both Krumholz and Ross have consulted for the plaintiffs in lawsuits against Merck. Their co-authors also report having received fees from several pharmaceutical companies. Merck did not respond to a request for comment on the new findings.

Dr. John Baron of Dartmouth Medical School in Lebanon, New Hampshire, who oversaw the colon-polyp study for Merck, said most experts now believe the increased risks are a common trait among COX-2 inhibitors. He said a new study testing all the drugs in the class is in the works. "The most important analysis will be the combined analysis that will give more information regarding the individual drugs as well as presumed class estimates," he told Reuters Health.

SOURCE: link.reuters.com/van89q (http://link.reuters.com/van89q) Archives of Internal Medicine, online December 13, 2010.


12-15-10, 10:05 AM
The important take home message here is for consumers, especially of OTC medications, is to recognize that painkillers and anti-inflammatories are two different types of drug. As has been discussed elsewhere in this forum recently, there is a growing tendency for consumers to buy anti-inflammatory medicines when they should in fact be purchasing painkillers. There are risks associated with anti-inflammatory medicines that should by rights see them taken off shelves and made available as pharmacy only or prescription only.

12-15-10, 12:56 PM
LabDoc, can you be more specific? Brand names in NZ may not match up with ours, but generic names like ibuprofen will be recognizable.

12-15-10, 02:22 PM
LabDoc, can you be more specific? Brand names in NZ may not match up with ours, but generic names like ibuprofen will be recognizable.

Looks like you have NZ on your mind Islander - you must be overdue for a visit here. LabDoc is in Oz.

12-16-10, 09:20 AM
Sorry. Naproxen and Ibuprofin - anti inflammatory, not sure about classing salicylates (aspirin) with them.
Paracetamol, aspirin, codeine etc. - painkillers

12-16-10, 10:07 AM
Asprin has mild anti-inflammatory properties-considered an NSAID (non-steroidal anti-inflammatory drug).
In the US naproxen (Aleve) and ibuprofen (Motrin)
are given for pain as well as inflammation, so the average OTC is confused. I can remember when ibuprofen was Rx only.

12-16-10, 12:02 PM
I can remember when ibuprofen was Rx only.

And those who have worked in settings where meds were dispensed know how much ibuprofen equals a prescription dose. I used to take it on days when I was going to spend the afternoon working in the garden. I was taking it for pain, but my chiro recommended it for inflammation. I only use it when I know my back and I are going to be at war.

12-16-10, 12:29 PM
It is one of the worst for GI bleeds-it seems almost everyone in my extended family when they hit 80 got hospitalized for ibuprofen-induced GI bleed and had transfusions.

Your gut lining gets more fragile as you age (think how your skin looks) so these meds can cause more harm.

12-16-10, 12:32 PM
I promise to be careful. I may have created the impression that I use more than I do. Most heavy labor days I just soldier on.

12-16-10, 12:36 PM
I promise to be careful. I may have created the impression that I use more than I do. Most heavy labor days I just soldier on.

You use a great deal of wisdom and restraint-that warning was for forum members with family members/friends who take it on a daily basis. LabDoc ran a coagulation lab and witnessed first hand how these drugs can alter your clotting mechanism and his advice is very good.

12-16-10, 07:29 PM
I remember a patient we had many years ago, a doctor himself, who was self medicating on ibuprofen for arthritis. He had been increasing his doses to mega amounts over a couple of years. Presented with lethargy, weight loss, easy bruising - one blood sample later - he had Acute Leukaemia, survived only two months. He was the lovliest fellow and spent his last months beating himself up for his stupidity. (Exasperation) Why is it always the nice ones...
Despite my killer Asprin allergy, I never touch NSAIDs, I guess if you have to use them - smallest effective dose for as short a time as possible.

12-16-10, 07:34 PM
LabDoc, do they think the ibuprofen caused the leukemia?

12-17-10, 01:01 PM
I realize no NSAIDS are safe. I cannot take aspirin as it causes GI bleeding, even 81mg daily. However, I do have severe chronic pain and at one time I was taking nearly 300mg of morphine/day. Most of the time the pain is bearable with nattokinase and fish oil but occasionally I do have to take something else. I've done extensive research and I feel that naproxen is the safest NSAID out there so that's what I take when I absolutely have to.