I wrote this 2 months ago – Is it a class effect
I would not take a Cox-2 at this time for more than a short course. But then, I would not have taken these drugs chronically prior to the Vioxx announcement. I will avoid prescribing this class except under very clear, narrow indications.
Today, the NEJM released results for Celebrex – Pfizer Says Painkiller Tied to Increased Risk of Heart Attack
Pfizer Inc. said it has found an increased risk of heart attacks with patients taking its top-selling painkiller Celebrex, a drug that is in the same class as Vioxx, but has no plans to remove it from the market.
Pfizer announced Friday that it found the increased risk in one of two long-term cancer prevention trials, while the other trial showed no increased risk.
The National Cancer Institute, which was conducting the study for Pfizer, suspended the use of Celebrex after discovering that patients taking 400mg to 800mg of the drug daily had a 2.5 times greater risk of experiencing major heart problems than those who were not. A separate cancer study found no increased heart risk with patients taking 400mg of Celebrex per day.
Pfizer says that they have no plans to withdraw Celebrex at this time. I wonder who is advising them?
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9 Responses to Celebrex – as I predicted
isemmelweis » Blog Fodder
December 17th, 2004 at 9:45 pm
[...] Blog Fodder
Filed under: General — Trapper @ 4:43 pm
Medpundit, DB, and HCRenewal think celebrex is next. Shrinette makes a decision. SoloDoc an [...]
RGL
December 17th, 2004 at 1:30 pm
This news is all over TV today. Not unusual that Dow Jones is down again, as it was when Vioxx was withdrawn on September 30.
Pfizer is probably going to say that the doses employed were twice the usual dose for arthritis, which would give the company a little wiggle room. But that is little comfort to those now using it, who I predict will stop using it en masse.
This would be true as well for Pfizer’s other product, Bextra, which Dr. David Graham of the Office of Drug Safety already warned of possible similar side effects as Vioxx when he appeared before the Senate Finance Commidttee.
This announcementn today will likely hasten
changes many felt were needed at the FDA.
ck
December 17th, 2004 at 3:01 pm
Realize however, that this risk was found to occur in doses 4x the normal prescribed amount. Hardly worth a call for withdrawal.
Aaron
December 17th, 2004 at 3:04 pm
Dr. Centor,
The NEJM does not carry the Celebrex report. The study that led to today’s announcement was the APC study – a NCI trial of colorectal adenoma prevention using celebrex. It has not been published yet, not even in abstract form, I believe. The Safety Monitoring Board sent a review to Pfizer with the prelim analysis last nigh, leading to this morning’s announcement.
The only ‘report’ (and the one you are showing in your post) is an AP news article.
What is on NEJM is a letter from Drs. ray et al advising to stop prescribing valdecoxib as well.
I have some details on my blog , should anyone be interested.
arf
December 20th, 2004 at 10:38 am
Agreed, db, the “class effect” is not surprising.
But……..can we compare these drugs with NOTHING?
Patients who go off COX-2 drugs will likely go to either “traditional” NSAID’s or opiates.
Are they without side effects?
Have we pulled the older NSAID’s off the market because they caused renal dysfunction or GI bleeds?
Yes, we pulled NSAID’s like Duract off the market when the side-effect profile was higher than the “baseline” of the other NSAID’s. We seem to be willing to put up with a certain “baseline” of morbidity and mortality with the other NSAID’s.
Will that happen with the COX-2 drugs?
{/rhetorical question]
Roxanne
December 20th, 2004 at 2:01 pm
Patients who go off COX-2 drugs will likely go to In response to the comment about the potential side effects of “traditional†NSAID’s or opiates,” well, yes, all drugs have side effects. However, one always has to weigh benefit and risk. In the case of vioxx, for example, the benefit certainly did not outweigh the risk. Up to 100,000 people may have suffered a stroke or heart attack for taking a drug that was, if you will, not “necessary.” By not necessary, I mean that it was not for a life threatening condition. There are alternatives, which have side effects as was pointed out, but I don’t know of any data indicating that 100,000 have had strokes due to over the counter NSAIDS. Celebrex now appears to be going down the same road as Vioxx. Merck didnn’t want to voluntarily withdraw Vioxx, even after the evidence became overwhelming.
Have we pulled the older NSAID’s off the market because they caused renal dysfunction or GI bleeds?
arf
December 20th, 2004 at 3:10 pm
>>Have we pulled the older NSAID’s off the market because they caused renal dysfunction or GI bleeds?
Duract and Zomiperac come to mind. I think maybe one or two more in the last decade or so.
I forget the factoid, it’s about 16,000+ deaths annually from “traditional” NSAID’s.
Don’t get me wrong, I was not all that much of a fan of the COX-2 drugs either, though patients pressured me for the medicine all the time.
The drugs have a hurdle to surpass, in that “as good as” traditional NSAID’s is not good enough, when the cost is about ten times more. If, when all is said and done, the choice is just “choose your poison”, you might as well go for the cheaper poison.
It seems every time someone touts a “better” NSAID, they end up eating their words in a couple years.
bob condon
December 24th, 2004 at 11:03 pm
My comment (#5) posted above under “Aleve” is also pertinent here. Other observations:
1) Dr Graham, while entitled to his opinions, has made projected estimates of worst case scenarios; there is little hard data, and Graham’s numbers are just spin about mortality risk; he may be wrong by a log order or even more!
2) the CV risk, even if real, may be a dose threshold phenomenon (like water intoxication).
3) Obviously, a controlled trial, stratifying CV risk, and using usual doses of COX-2’s is the next step.
Lori Pratt
April 9th, 2007 at 8:33 am
What is the possibility of side effects and what are they for going off celebrex ????
L.Pratt