Pradaxa Bleeding Problems Reported

The FDA announced Ottawa University study results which show that Pradaxa may cause more severe bleeding than reported by the manufacturer at the time the drug was approved.

There were some deaths which may have been prevented by closer blood screening... .

The manufacturer is said to have withheld vital information.

Reported by Nathan Fortin in Wallstreet OTC two hours ago.

azviking

15 Comments

Thanks IAN, INGA and Donr

by azviking - 2014-07-27 01:07:53

For a helpful discussion, and

hoping for rain in the desert.


azviking

Normal

by golden_snitch - 2014-07-27 03:07:15

Thanks for sharing. But that's normal and totally expected. What do you think happened the first couple of months or years after Warfarin/Coumadine etc. came on the market? LOADS of bleeding issues were reported. Once the drug became standard therapy, and doctors got to know it better, they reported less. A lot more people are now taking Pradaxa than those that participated in the studies. So, of course more complications are being reported. And because it's a rather new drug, doctors report more often than they do for Warfarin. Give it a few years, and - as the study results suggest - the bleeding complication rate will come down and be about the same or a little better than with Warfarin.

Inga

Pradaxa

by Roys - 2014-07-27 06:07:04

I think the point is that, the manufacture is said to withheld VITAL information. The manufacture is said to have settled in 2014 more than 4000 lawsuits for $ 650 million, and is making billions of profit.

It seems to me that ..

by IAN MC - 2014-07-27 08:07:42

.. all blood thinners are potential dangerous in that they can all cause bleeding problems. I believe that warfarin is still one of the leading causes of fatalities in emergency treatment centres.

Whereas vitamin K can act as an antidote for bleeding caused by warfarin, as far as I am aware there is no known antidote for Pradaxa-induced bleeding.

So , as a potential patient, my concern would not be which one is most likely to cause a bleed . Inga may well be right that the bleeding complications may be similar with both, only time will tell , but my MAJOR concern would be what happens if you do get a bleed ?

I would refuse to take Pradaxa until an antidote to its bleeding is discovered.

The issue of the manufacturer withholding vital information is worrying.

Ian

Bleeding prolblems

by Roys - 2014-07-27 09:07:46

To control bleeding with Warfarin you can have your own INR Meter at home, to keep a better check on INR levels. But with Pradaxa you have no way of knowing what your blood is like. My Doctor has told me to go on Warfarin, and to get a INR meter.
Roy

azviking

by azkaren - 2014-07-27 10:07:21

Yes, we need rain!

Ian

by golden_snitch - 2014-07-27 10:07:26

... if you suffer any serious injury, vitamin K won't help at all with the bleeding. That's what I have been told by several cardios/EPs AND neurologists (with regards to bleeding in the brain). They are already testing an antidot for Pradaxa. My EP said that he's expecting it to be available at the end of the year or beginning of next year. Until then, if you bleed, you'll get a plasma infusion or something like that - EP explained it, but I can't remember the technical term -, very much like a platelet infusion. But you get that, too, when you are on Wafarin and suffer serious bleedings from, for instance, a car accident. Again, vitamin K in a situation like that won't work or won't work fast enough.

Inga

Inga

by IAN MC - 2014-07-27 11:07:26

As I was writing my last reply I was thinking to myself " if warfarin is a leading cause of fatalities in emergency treatment centres " then the antidote can't be that good !

Let's hope that Boehringer's antidote for Pradaxa works , when it eventually appears !

Thanks for the clarification

Ian

Let's compare testing...

by donr - 2014-07-27 11:07:44

...requirements for diabetes & for anticoagulation. I recall literally a lifetime ago the the onerous nature of blood sugar testing and how it has improved & been simplified for diabetics till now they advertise micro drop, near painless testing.

INR testing is still in the dark ages of technology & just today emerging into a nearly user-friendly technology employing a small device that the average patient can use.

I am a warfarin user & have been since the fall of 2002. The periodic trips to the hosp/lab for testing are a pain - but the blood drawing is just an inconvenience. I hear a lot of people complain about the drawing part of the test as their primary unhappiness w/ warfarin.

Diabetics may have to test up to multiple times per day - at least science has developed a testing protocol that is far more acceptable than INR testing at this time. But, OTOH, by the nature of the coagulation dependence on far more complex body chemistry at least warfarin users only have to test less frequently.

Put decent INR self testing gear in the hands of those who need it at the same % as for sugar level testing for diabetics & a lot of the objections to warfarin might go away. The world is moving that direction. When I first started on warfarin, the Medicare justification requirements for home testing were pretty stiff. Today, a bit over ten yrs later they have been relaxed significantly.

In my book, the Pradaxa situation still is out w/ the jury of public opinion. If, long run, the statistics on side effects come down to match Warfarin it will be more widely accepted. Then it will be purely a judgement call based on the availability of an antidote for Pradaxa.

Donr

Anyone Know the Risk Levels?

by azviking - 2014-07-27 12:07:12

The discussion is educational for this newby. I am impressed with what I learn on this website and how better prepared I am to live with my pm.

When Xerelto was prescribed to "reduce the chances of a stroke" I asked myself.... Reduced from What to What?One in a Thousand to One in Five Hundred? One in Ten Thousand to ? One in a Hundred to ?

Anyone know the numbers?

Balanced against side effects.- including bleeding.

The doc recommended it so the med must have value for my situation.

azviking

Don

by golden_snitch - 2014-07-27 12:07:15

"INR testing is still in the dark ages of technology & just today emerging into a nearly user-friendly technology employing a small device that the average patient can use."

I have done INR home monitoring since 2005, and the device I got for that was already a Roche Coaguchek S. The first Coaguchek dates back to 1994. German patients have used them for many years, it's just that in the U.S. many insurances don't pay for them and so you are not that familiar with them. Here insurance has to cover them. In Germany more than 200.000 patients are using an INR home monitor. It's well studied, and proven to be much better than the monthly lab check.

Inga

There copmes a point...

by donr - 2014-07-27 12:07:38

...in bleeding situations where the ONLY antidote is surgical intervention.

Face it - cut a major vein or artery & the only solution is a hemostat.

NO anticoagulant has any influence in that extreme situation. They only influence minor level bleeding & creation of clots w/i the vascular system.

Cut off a leg & the only way to stop bleeding is a tight tourniquet or an injection of plaster of paris. Although - there is a research program that has developed, (or is developing) a granular substance based on chito (Not sure of the spelling), a substance found in shrimp shells, that if injected into a major hole from a wound will cause the blood to clot up in major qtys nearly instantly - almost like plaster, only faster.

Donr

Risk factors

by IAN MC - 2014-07-27 12:07:58

According to my cardiologist :-

- I in 6 people who have strokes also have atrial fibrillation

- Blood thinners can reduce the risk of your first stroke by around 70 % if you have atrial fibrillation

.. but life is never that simple , there are individual risk factors that you can do nothing about e.g your age, your sex, your genes

- as you know , if you have a fib, you may get a stroke because the heart chambers don't empty properly and the reservoir of blood may form clots . So it depends a lot on how severe and how frequent your a fib is . We are all different !

- then if you have a fib and a blood thinner, what are the risks of having a bleed ? Again this is something of a minefield. Some patients are at low risk of having a bleed, some intermediate and some are high risk .

Apparently if you are intermediate or high risk , the chances of having a bleed are somewhere between 0.9 % and 2.5 % ( depending on what you read ! )

So really it is definitely worthwhile taking blood thinners if you have a fib , because having a stroke is best avoided. If I frequently had an irregular heart rhythm, I would definitely take a blood thinner, probably warfarin.

But I looked at all the risk factors and decided to have an ablation which cured my a fib at the first attempt which meant no more blood thinners for me . But I was lucky ( and had a VERY good Dr doing the ablation ! )

Cheers

Ian

Pradaxa

by JoMarie - 2014-07-28 07:07:14

I have been on Pradaxa now for about six months. I have no side effects, no dietary restrictions, no needles, no sleeplessness or hair loss (all Warfarin side effects for me). My quality of life is vastly improved and I will take the risks associated with this wonderful drug in the same way as I take a risk crossing the road.... or having a stroke or heart attack.

Inga was correct....

by donr - 2014-07-28 08:07:33

....and DANG!!! I hate it when that happens.

Yes, we are significantly behind Germany in PST (Patient Self Testing) for INR. Courtesy of our wonderful Medicare System & hyper-sensitivity to safety by the Food & Drug Administration (FDA). I did a little research & found the following:

1) There are three PST approved devices - the Roche Coagu chek is but one of them, & apparently the most widely used. The model XS that I have is the 5th generation machine available. Inga talked of having a Model S in 2006 (or thereabouts).

2) The error factor for the XS reached a max of about .5 in INR. For the XS, the same measure is about .1. Sounds pretty bad for the S model, compared to the newer XS. But there are other factors to consider!

3) I was correct about the TECHNOLOGY coming out of the dark ages, but ignored a second, MORE IMPORTANT factor. Specifically the HUMAN factor. In the US, physicians have been using the Coagu Chek devices since 1994 - a long time ago. They used them for POC (Point of care) management of patient's INR's. A study showed that just that change from chasing folks off to the lab for a poke in the arm worked wonders at reducing adverse effects for patients. Pushing the testing down to the patient improved it even further. Why? Because it was far more convenient for the patient & not as unpleasant.

3a) Talk about HUMAN factors !!! How many Phlebotomists (Meaning those humorless vampires who suck the lifeblood out of our arms) have you ever met who smiled & were pleasant? I swear that they must spend their spare time between patients sucking on lemons or grapefruit. I've met exactly 2 - Dana & Monique. It was actually a pleasant experience to see them.

4) Even w/ the devices w/ the possible .5 error in INR adverse effects were reduced. WHY? Because variations in INR requiring modification in dose were caught SOONER than using the lab for testing. Medicare began loosening up in about 2008 when the studies convinced them that there were significant advantages to PST. Private insurance companies followed.

5) It's no big deal w/ home testing for the patient to run a weekly test sitting at the kitchen table after breakfast & sticking themselves in the finger - just like Diabetics have been doing for years on a daily basis.

6) Once again, the mental is to the physical as three is to one (Napoleon)

Donr

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