Dibagitran / Pradaxa ( Do not Take it ????)

[Freddie]

Anticoagulation

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More information on Dibagitran in New Zealand, do not use it ????
A coronial investigation has been launched into the deaths of people taking the blood-thinning drug Pradaxa, as the death of a Bay of Plenty man brings to at least five the number of patients who have died after taking the new medication.

Bay of Plenty regional coroner Wallace Bain, concerned that the deaths were signed off without coroner's hearings, has stepped in to investigate. He has 40 years' experience as a pharmacist.

The Sunday Star-Times has been told of the deaths of five Pradaxa patients – all elderly – and the Centre for Adverse Reactions Monitoring (Carm) at Otago University says it has been alerted to four. It is unclear if they are the same people. Pradaxa became widely available in July when Pharmac announced it was fully funding the medicine after signing a deal with a drug company worth up to $155 million over five years.

A Star-Times investigation over the past month has uncovered concerns about Pradaxa within the medical fraternity, because it cannot be monitored and there is no antidote in the event of a major bleed. There is also evidence that doctors have been prescribing Pradaxa to those at higher risk, such as over-75s with poor kidney function, low weight and replacement heart valves.

Dozens of patients have experienced adverse reactions, from gastro-intestinal problems to serious bleeds requiring multiple blood transfusions, but MedSafe is satisfied the benefits of the drug outweigh the risks.

Carm director Michael Tatley said the deaths his centre had investigated were caused by factors other than Pradaxa, such as infections. But some families say the chain of events leading to their relatives' deaths began when they switched from warfarin to Pradaxa, and infections set in only after their conditions had deteriorated to the point of hospital admission.

"We all feel certain that had my father remained on warfarin, he would still be sitting in his garden in the sun today and looking forward to Christmas with his family," said Chris Thompson, whose 77-year-old father, Rod, died in Tauranga Hospital last Sunday.

The daughter of a 92-year-old Hawke's Bay woman who died in August said: "I have no doubt in my mind that Pradaxa killed my mother. Now I'd like to know why they didn't monitor her and why she was moved on to it in the first place. It appears highly negligent."

Bain, former vice-president of the Pharmaceutical Society, said he had decided to investigate further after reading of adverse reactions to Pradaxa, also known as Dabigatran, in the Star-Times.
I personally think that any Doctor or Cardio who prescribes this drug and there is a subsquent death as a result should be charged with Manslaughter !

 

[nngbwh]

Thanks for the info, Freddie.

 

[markp66]

I'm not sure why any elderly people have been put on pradaxa as it's a known fact that it causes higher rates of bleeding for people over 70. However, as with any new drug it seems to take time to understand how it works and interacts with different people. It seems like doctors don't do enough research and it is so easy for them to write a prescription without being aware of the potential consequences. I'd always double Check any drugs a doctor gives you from antibiotics that can potentially be dangerous with warfarin to new drugs which aren't fully understood. I think you have to assume that doctors don't know everything and do your homework first.

 

[Protimenow]

markP66 is right -- doctors don't often know enough about interactions and approved uses of medications. Drug reps (they call themselves 'detail' persons) push the new medications, and doctors often get lavish meals and talks promoting medications. Pradaxa ($8 a day) does what warfarin (about a dime or so a day) does - but, as noted above, without an antidote. It's only approved for A-fib in the United States. I don't know about Australian approvals.

For the elderly, there may be some concerns about monitoring INRs among the elderly (non-compliance with dosing, missing testing appointments or ??), but I don't know that Pradaxa is a better alternative -- even if Medicare pays most of the cost.

Pharmacies are pretty good about pointing out drug interactions - but they can only point out interactions with medications that they dispense -- OTC products that may cause coagulation problems fall under their radar.

So -- it's important that WE check these things out - test when needed - and watch for changes if we make changes to our diets or medications - whether prescription or otherwise.

 

[ElectLive]

markP66 is right -- doctors don't often know enough about interactions and approved uses of medications. Drug reps (they call themselves 'detail' persons) push the new medications, and doctors often get lavish meals and talks promoting medications. Pradaxa ($8 a day) does what warfarin (about a dime or so a day) does - but, as noted above, without an antidote. It's only approved for A-fib in the United States. I don't know about Australian approvals.

For the elderly, there may be some concerns about monitoring INRs among the elderly (non-compliance with dosing, missing testing appointments or ??), but I don't know that Pradaxa is a better alternative -- even if Medicare pays most of the cost.

Pharmacies are pretty good about pointing out drug interactions - but they can only point out interactions with medications that they dispense -- OTC products that may cause coagulation problems fall under their radar.

So -- it's important that WE check these things out - test when needed - and watch for changes if we make changes to our diets or medications - whether prescription or otherwise.

I read an interesting medical editorial today about Pradaxa that went into great detail about the issues of both cost and effectiveness. It's lengthy but here's a link to the full text for anyone interested: http://circ.ahajournals.org/content/123/22/2519.full

Here are some of the highlights:

"Efficacy assesses the performance of a drug (or test, or procedure) under the ideal but atypical circumstances of the randomized clinical trial. But effectiveness takes into account how well something works in the actual context of everyday practice. These can differ substantially, and are quite likely to do so in the case of anticoagulation, for several reasons:

Dabigatran is administered twice a day and has a relatively short half-life; there is evidence that a medication that must be taken twice a day is more likely to have doses missed than a drug (like warfarin) taken once a day.

An even greater potential cause of poor adherence is the drug's cost; we know that patients adhere less well to expensive drugs than to their more affordable alternatives,14 and at $3000 per year (or with a correspondingly high co-payment) this could be an enormous concern for many patients. Stretching out doses of a costly drug will, in this case, mean that patients who try this strategy will be more likely to have their anticoagulation drop to nonprotective levels, increasing their risk of stroke.

When a patient taking warfarin veers above or below the ideal range of anticoagulation, it can be detected with an INR test; but no such testing is available for dabigatran.

If a patient bleeds while taking warfarin, there are well-documented ways of reversing its effect on the coagulation cascade; for dabigatran, no such well-tested antidote is available.

We have generations of experience with cessation of warfarin before planned surgery, as well as correction of the INR in the face of emergency procedures or trauma; no such experience is available for the new drug.

Dabigatran has far less of a track record of adverse effects, because it was introduced into use so recently. When ximelagatran was approved for widespread use in Europe, it too was a new, safe direct thrombin inhibitor alternative to warfarin—until it was not.

Patients in the unblinded RE-LY study were in an acceptable INR range only 64% of the time. Although this is comparable to or better than many clinical settings, it is far from ideal, especially for a well-resourced clinical trial. What would be the effect of spending part of the incremental cost of >$2000 per patient per year on hiring legions of anticoagulation nurses or pharmacists to achieve better control with warfarin?

More experience will be needed before we can really understand the actual benefit-risk relationships inherent in dabigatran as used routinely, and, therefore, its cost-effectiveness, as well...

A key next step will be to see how dabigatran fares in the bumpy, messier setting of typical patient care, where it may well perform differently than RE-LY would suggest... there is merit to the recent joint professional society recommendation of the American College of Cardiology and the American Heart Association that for those who are currently stable and doing well on warfarin until we learn more, staying the course with that annoying old standby may be a prudent—and certainly affordable—course of action for the near future for many other patients." -- Jerry Avorn, MD, Harvard Medical School, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital


Also, by the way, back to part of the title of this thread - "Do not take it???" Most everyone here probably is already aware that the trial and approval (in the US) of Pradaxa to date specifically is not for mechanical valve patients. Beyond that, though, it was a very limited A-Fib approval as well. Patients specifically excluded were those with any prosthetic heart valve (tissue included) and/or hemodynamically significant valvular heart disease. So, that would exclude just about everyone here...

 

[bdryer]

Hi kids

Saw the cardiologist on Oct 5 for my 6 mth post op follow up. He took the lead and stated that Pradaxa is the future. I mentioned the shared research from this thread and stated I was comfy playing with Warfarin. He affirmed that the research is still in it's infancy and that a methodology for administering and monitoring Pradaxa was in development.

For now, I'm spending my cash on test strips for my CoaguChek XS. We need more people to purchase this unit, so that volume sales will reduce the cost!

 

[Protimenow]

I'm not convinced that volume sales -- whatever the volume - will convince Roche (and probably also Alere and ITC) to reduce the cost of the strips. Personally, I'd like to see the meters priced at below $100 each, and the test strips at $1 or less. I would also like to see the tests done weekly by anyone on warfarin. It makes little sense to me that a person should be allowed to wait weeks or months between tests, and the medical establishment assume that, if two results taken months apart match, this person's INR is stable.

If I take two different doses during the week, it stands to reason that my INRs during the week will also vary from day to day -- but there isn't testing being done to confirm it. A result only shows your IMMEDIATE INR based on dosing in the past few days, diet, other medications you take, herbal supplements you may take, whether or not you've taken an antibiotic, and other factors -- it should not be taken to represent what your INR was a few days ago or what it will be in a few more days.

If people were testing more frequently, and there WAS a demand for more supplies, perhaps the prices could be driven down.

I certainly hope that some day this will happen. But, with the medical community still doing its monthly testing -- and people accepting this as good practice -- I don't see any price drops for a LONG time.

 

[Jason]

Thanks for passing this along. My father is on warfarin for A-fib, and the medical experts were trying to get him to switch to Pradaxa. Other than the risks of a relatively new drug, the costs were astronomically higher. He chose to stay with the devil he knows. I am glad he did.

I agree with the comments on the coaguchek. I would like to have cheaper strips as well.

 

[Protimenow]

I'd worry about Pradaxa. There's an advertising blitz for this drug that costs $8 a day (I'm told). Warfarin may take a bit of finesse to manage, but it's about a dime or two a day, and can be easily and quickly reversed, if the INR is too high. It's also pretty easy to test the INR.

If it was me - or my father - I'd stick with warfarin.