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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 17 of 17. This is the beginning of the thread.
Posted by ed_uk on April 9, 2005, at 11:10:11
EUROPEAN SUSPENSION OF BEXTRA
The EMEA has today announced a voluntary suspension of Bextra sales and
marketing, pending the completion of the review of safety of Cox 2’s, which is
ongoing. “Today’s announcement reinforces our previous advice that Cox 2’s should
be used after careful consideration of risks and benefits and the lowest effective dose
for the shortest duration of time”, says Professor Gordon Duff, Chairman of the
Committee on Safety of Medicines.
The concern about Bextra relates to reports of suspected serious skin reactions
which are now under review. This action is in line with the voluntary suspension of
Bextra in the USA. The previous advice on cardiovascular risk associated with Cox
2’s is unchanged.
In line with the European action, the MHRA is today issuing updated advice to health
professionals and patients on Bextra and advise that patients should see their doctor
at the next convenient appointment to arrange alternative pain relieving treatment.
Most suspected adverse reactions have incurred in the USA where Bextra has been
used more extensively. Professor Kent Woods, MHRA Chief Executive says “we
support the EMEA action in advising health professionals and patients of this new
safety concern. There is no immediate new risk and it is important that we review all
available data before reaching a final position.”Letter to Healthcare professionals in the UK.....................
DDL Valdecoxib v6f 070405
VOLUNTARY SUSPENSION OF VALDECOXIB (BEXTRA) BY PFIZER LTD
Dear Colleague
I am writing to inform you of the voluntary suspension of the sales and marketing of
valdecoxib (Bextra) by the manufacturer in Europe and the US. This action follows
increasing concerns about the risk of serious skin reactions, including Stevens-
Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), in addition to
established class evidence of cardiovascular risk, with the selective COX-2 inhibitors.
Safety data for valdecoxib
Valdecoxib is associated with a higher rate of serious, potentially fatal, skin reactions,
including SJS and TEN than other COX-2 inhibitors. The increased number of
reports of severe skin reactions has been particularly notable in the US, where usage
has been much higher than in Europe. Recent company figures show 155 reports of
serious cutaneous adverse reactions (SCARs) world-wide, and an overall reporting
rate of 7-8 cases per million patients. Most reported cases occurred within 2-3 weeks
of starting treatment. In the UK, it is estimated that less than 40,000 patients received
valdecoxib in the last 12 months, and we have received 2 reports of serious blistering
conditions, through the Yellow Card Scheme.
As previously noted, the evidence also suggests an increased risk of thrombotic events
associated with the selective COX-2 inhibitor class of drugs. CSM advice of 17
February 2005 still applies – see below.
Advice for patients
Patients who have been taking valdecoxib regularly for more than 3 weeks should
make a routine appointment to arrange alternative treatment, but may continue taking
valdecoxib until alternative treatment has been arranged. Patients who have recently
started valdecoxib (within the last 3 weeks) should be advised to stop treatment, to
avoid the small risk of skin reactions, and to see their doctor to arrange an alternative.
Cardiovascular safety of COX-2 inhibitors
In February, I wrote to you with updated advice on the cardiovascular risks of
selective COX-2 inhibitors (celecoxib, valdecoxib, parecoxib, etoricoxib). The same
advice applies today:
• Selective COX-2 inhibitors should not be prescribed in patients with
established ischaemic heart disease, cerebrovascular disease or those with
moderate heart failure (NHYA class II-IV).
• For all patients, the balance of gastrointestinal and cardiovascular risk
should be considered before prescribing a COX-2 inhibitor, particularly for
those with risk factors for heart disease and those taking low dose aspirin, for
whom gastrointestinal benefit has not been conclusively demonstrated.
• The lowest effective dose of COX-2 inhibitor should be used for the shortest
necessary period. Periodic re-evaluation is recommended, especially for
osteoarthritis patients who may only require intermittent treatment.
• Gastroprotective agents should be considered for patients switched to nonselective
NSAIDs.
Cardiovascular safety of non-selective NSAIDs
New advice arising from appraisal in the US highlights the current lack of long-term
clinical trial data supporting the cardiovascular safety of less selective NSAIDs such
as meloxicam, and etodolac, and non-selective NSAIDs, such as naproxen and
diclofenac. It is important to note that in the absence of clear evidence, we cannot
conclude that these medicines present the same or different cardiovascular risks as the
highly selective ‘coxibs’. The CSM is reviewing the available evidence and will
provide further advice as necessary. In the meantime, it is advisable to use the
lowest effective dose of NSAID for the shortest time necessary. No other changes
to prescribing practice are recommended at present.
Further assessment
The overall risks and benefits of selective COX-2 inhibitors, as well as other NSAIDs,
will be further reviewed in detail by CSM, and I will inform you of any new advice as
soon as it is available. Please report suspected adverse drug reactions to the MHRA
and CSM using the Yellow Card Scheme. This is an important source of information
on adverse drug reactions and we are currently piloting direct patient reporting
through the Yellow Card Scheme (website at www.yellowcard.gov.uk) and using
paper-based Patient Yellow Card report forms. Patients may contact the MHRA if
they would like a form (send an email to patientreporting@mhra.gsi.gov.uk or
telephone - ( 44) 020 7084 2101). A set of questions and answers for patients is
attached.
If you have any enquiries, please contact the MHRA (medicines) on 020-7084 2000
or e-mail info@mhra.gsi.gov.uk.
Yours sincerely
Prof. G Duff
Chairman
Committee on Safety of Medicines
Posted by MidnightBlue on April 9, 2005, at 11:10:11
In reply to European suspension of Bextra, posted by ed_uk on April 8, 2005, at 19:02:40
Ed they announced it here in the USA yesterday that they are pulling it. That is a drug I NEED. I have arthritis, bad back pain from degenerated discs, a broken rod from years ago, and GERD. I don't do well on NSAIDS. I have worked my way through just about all of them. I don't want to have to take narcotics.
I am rationing out the last of what I have. Celebrex is still on the market as of today, but I don't know for how much longer. I was on Vioxx years ago before Bextra. It is banned, too.
For me depression and pain are mixed. My depression makes the pain worse, and of course pain makes the depression much worse. I am just sick over this.
Posted by ed_uk on April 9, 2005, at 12:39:20
In reply to Re: European suspension of Bextra » ed_uk, posted by MidnightBlue on April 9, 2005, at 0:06:46
Hi,
Have you tried meloxicam or etodolac?
Regards,
Ed.
Posted by gromit on April 9, 2005, at 13:23:36
In reply to Re: European suspension of Bextra » ed_uk, posted by MidnightBlue on April 9, 2005, at 0:06:46
> Ed they announced it here in the USA yesterday that they are pulling it. That is a drug I NEED. I have arthritis, bad back pain from degenerated discs, a broken rod from years ago, and GERD. I don't do well on NSAIDS. I have worked my way through just about all of them. I don't want to have to take narcotics.
Well crap, my doctor just convinced me this week that I need to start taking it again long term. When they pulled Vioxx I got worried and stopped taking Bextra. I have degenerated discs and arthritis in my neck.
Maybe you can ask on the alternative board, turmeric is supposed to be a good cox-2 inhibitor but it takes time before you start feeling better. I was doing ok with just supplements and chiropractic + massage until I took a spill recently. This stuff does work, at least for me. Lots of ice helps too.
> For me depression and pain are mixed. My depression makes the pain worse, and of course pain makes the depression much worse. I am just sick over this.
Wow can I relate to this. When the pain never stops it just wears you down, I was never really depressed until I got hurt. Maybe you can try something like Elavil? If you can stand the next day sedation it really helps, especially with sleep.
Rick
Posted by Larry Hoover on April 9, 2005, at 13:27:09
In reply to Re: European suspension of Bextra » ed_uk, posted by MidnightBlue on April 9, 2005, at 0:06:46
> Ed they announced it here in the USA yesterday that they are pulling it. That is a drug I NEED. I have arthritis, bad back pain from degenerated discs, a broken rod from years ago, and GERD. I don't do well on NSAIDS. I have worked my way through just about all of them. I don't want to have to take narcotics.
>
> I am rationing out the last of what I have. Celebrex is still on the market as of today, but I don't know for how much longer. I was on Vioxx years ago before Bextra. It is banned, too.
>
> For me depression and pain are mixed. My depression makes the pain worse, and of course pain makes the depression much worse. I am just sick over this.This may sound a little "out there", but you might have a useful drug in your spice cupboard.
Turmeric.
It contains one of the most potent COX-2 inhibitors ever found, in natural substances.
Animal studies have shown no toxicity, at very large doses. And it has very potent anti-tumor (anti-cancer) effects, as well.
I buy turmeric at the bulk food store, and a dose costs about 10 cents, or less.
I take a heaping teaspoon full, and stir it into about four ounces of water. Be very careful. Turmeric can stain many materials, including your skin, countertop, clothing.... It's a tad bitter/weird, but not distasteful.
My experience with the COX-2 drugs, compared to turmeric, is that turmeric was better, and lasted longer, than any of them. I never used Bextra, but I had Celebrex, Mobicox, Vioxx, and one other.....Turmeric beat them all, in this man's body.
Gabapentin (I'm only on it two weeks, so far), seems to manage my joint pain, too. They've finally discovered what receptors the drug works at.... weird name, but it's the calcium channel {alpha}2{delta}-1 and -2 spinal receptors.
Gabapetin helps with certain kinds of chronic pain. A lot of the pain response occurs because of reprocessing at the spinal cord. We used to think of the spinal cord as merely a communication trunk line with the brain. And all the nerves as feeder lines to the spinal cord. But the spinal cord actually processes pain signals all by itself, and communicates back to the nerves sending the pain signal. The feedback signal can make the pain signal remain at a high level.
Anyway, gabapentin disables some of the feedback from the spinal cord. Makes the brain a bit numb, too, I might add. I hope I get used to that, or it fades with time.
Lar
Posted by gromit on April 9, 2005, at 16:34:52
In reply to Re: European suspension of Bextra » MidnightBlue, posted by Larry Hoover on April 9, 2005, at 13:27:09
> Turmeric.
>
> It contains one of the most potent COX-2 inhibitors ever found, in natural substances.Larry, how long did it take to have an effect?
Thanks
Rick
Posted by Larry Hoover on April 9, 2005, at 22:14:06
In reply to Re: European suspension of Bextra » Larry Hoover, posted by gromit on April 9, 2005, at 16:34:52
> > Turmeric.
> >
> > It contains one of the most potent COX-2 inhibitors ever found, in natural substances.
>
> Larry, how long did it take to have an effect?
>
>
> Thanks
> Rick45 minutes? Not sure, but around that.
Lar
>
Posted by gromit on April 9, 2005, at 22:40:12
In reply to Re: European suspension of Bextra » gromit, posted by Larry Hoover on April 9, 2005, at 22:14:06
> 45 minutes? Not sure, but around that.
Did you notice a reduction in pain when you first started taking it? I've been taking an extract 600 mg 3x a day for about 3 weeks now and haven't had much decrease in pain.
Thanks
Rick
Posted by MidnightBlue on April 9, 2005, at 22:57:01
In reply to Re: European suspension of Bextra » MidnightBlue, posted by ed_uk on April 9, 2005, at 12:39:20
Ed,
I don't recognize the names of either of those. I'll have to ask about them. Are you sure they are in the US? I have enough Bextra for a couple more weeks. I hope to finally get a doctor's appointment by then. Thanks.
MidnightBlue
Posted by MidnightBlue on April 9, 2005, at 22:59:34
In reply to Re: European suspension of Bextra, posted by gromit on April 9, 2005, at 13:23:36
Rick,
I absolutely can't tolerate elavil. That stuff is evil! It made me shake and my arms and legs tingle.
MidnightBlue
Posted by MidnightBlue on April 9, 2005, at 23:09:14
In reply to Re: European suspension of Bextra » MidnightBlue, posted by Larry Hoover on April 9, 2005, at 13:27:09
Larry,
I wrote down about the turmeric. I hate to say it but that stuff sounds nasty! And no, I don't have it in my spice cabinet. I'm not into Indian food. I started Omegabrite a little more than a month ago for depression mainly and with hopes it might help the aches a bit. I think my mood is slightly better, but my joints hurt as much or more than ever. I take 3 capsules a day. I don't think I'll go much higher.
I also take Evening Primrose Oil. I especially like the Royal Brittany brand. I cut back on it when I started taking Omegabrite. I do know the EPO had been helping with stiffness, etc. All I would have to do is miss a dose or two and I would really be in pain. I'm not sure why the Royal Brittany band was so much better, but I could feel the difference.
Thanks for your suggestions.
MidnightBlue
Posted by gromit on April 9, 2005, at 23:49:29
In reply to Re: European suspension of Bextra, posted by MidnightBlue on April 9, 2005, at 23:09:14
> Larry,
>
> I wrote down about the turmeric. I hate to say it but that stuff sounds nasty! And no, I don't have it in my spice cabinet. I'm not into Indian food.You can get concentrated extract capsules, that's what I've been taking.
Rick
Posted by gromit on April 10, 2005, at 0:01:04
In reply to Re: European suspension of Bextra » gromit, posted by MidnightBlue on April 9, 2005, at 22:59:34
> I absolutely can't tolerate elavil. That stuff is evil! It made me shake and my arms and legs tingle.
Wow, maybe you could try nortriptyline then, I haven't taken it but it's supposed to have less side effects. Maybe trazodone, I'm taking that now but I don't like it.
Rick
Posted by ed_uk on April 10, 2005, at 8:33:59
In reply to Re: European suspension of Bextra » ed_uk, posted by MidnightBlue on April 9, 2005, at 22:57:01
Hi!
Yes, I think etodolac and meloxicam are both available in the US- I'm not sure though. They are both partially selective COX-2 inhibitors. The reason I suggested them is that I think they are less likely to get withdrawn from the market than Celebrex.
Ed.
Posted by Larry Hoover on April 10, 2005, at 12:01:52
In reply to Re: European suspension of Bextra, posted by gromit on April 9, 2005, at 22:40:12
> > 45 minutes? Not sure, but around that.
>
> Did you notice a reduction in pain when you first started taking it? I've been taking an extract 600 mg 3x a day for about 3 weeks now and haven't had much decrease in pain.
>
>
> Thanks
> RickI've only ever used the whole ground rhizome (the spice itself). I can't speak for the efficacy of the extracts.
Lar
Posted by Larry Hoover on April 10, 2005, at 12:03:21
In reply to Re: European suspension of Bextra, posted by MidnightBlue on April 9, 2005, at 23:09:14
> Larry,
>
> I wrote down about the turmeric. I hate to say it but that stuff sounds nasty! And no, I don't have it in my spice cabinet. I'm not into Indian food. I started Omegabrite a little more than a month ago for depression mainly and with hopes it might help the aches a bit. I think my mood is slightly better, but my joints hurt as much or more than ever. I take 3 capsules a day. I don't think I'll go much higher.
>
> I also take Evening Primrose Oil.Fish oil works especially well with EPO (or other source of GLA). The combination is better than either one alone.
Lar
Posted by MidnightBlue on April 27, 2005, at 19:51:10
In reply to Re: European suspension of Bextra » MidnightBlue, posted by ed_uk on April 10, 2005, at 8:33:59
Ed,
I finally made it to the doctor today and I will probably try Mobic in about a month. I'm afraid Celebrex won't be on the market much longer. I have a few more Bextra and I'm going to take every last one of them.
This is the end of the thread.
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