New Medication: Pradaxa

In My Humble Opinion (IMHO)
#1

My Grandfather(soon to be 77 years old) was prescribed a new medication recently and my grandma is worried about giving it to him. He had a massive stroke back in January 2010 and was put on Coumadin (warfarin) but then had some really bad kidney problems and was put on Heparin shots instead a few months ago. Well he’s home now and giving the shots is a bit of a nightmare for us. I’m the only one that will give them. He can’t give them himself as he’s bedbound and paralyzed. We talked to his homecare doctor about the alternatives and she felt his kidney problem was resolved enough to change medications. The doctor opted for Pradaxa as it doesn’t need close monitoring like the Coumadin.

I guess what I’m asking is has anyone been on Pradaxa or know someone who has? Have there been any odd side effects? My aunt is a nurse and she told grandma not to listen to the tv commercials as they have to list every little thing, and that the side effects would probably be close to the the Coumadin…which he’s never had a problem with. Any information would be great. I think she’s worried because it’s such a new drug.

#2

Does your grandfather have atrial fibrillation? As of right now, that is the only indication that Pradaxa has. (It hasn’t been studied for DVT risks…yet)

In the studies that have been published so far (including the ones that led to FDA approval), Pradaxa is just as effective as warfarin (Coumadin) in preventing strokes and MI’s in afib patients, and actually more effective then warfarin in patients who weren’t closely monitored. Pradaxa has mostly the same risks of unwanted bleeding as warfarin in normal use (including hemorrhagic stroke [bleeding in the brain, VERY bad]).

Pradaxa doesn’t have the same monitoring requirements, and doesn’t have nearly as many drug-drug, or drug-food interactions as warfarin. The one side effect that Pradaxa has greater then warfarin is dyspepsia (gas, burping, etc). This is because the drug requires an acid environment, and contains some of its own acid in the capsule so it works best. So… Don’t take antacids at the same time as taking Pradaxa.

The major problem with Pradaxa… It doesn’t have a reversal agent. As of right now, there is no drug that will reverse the effect of Pradaxa in case of overdose, or excess bleeding. If someone does have abnormal bleeding on Pradaxa, there are currently two choices, give them fresh frozen plasma (blood products that contain all the clotting factors that Pradaxa blocks), and/or give them dialysis to clear the drug from their system. Also, the medication is VERY sensitive to humidity. Once a bottle is opened, it expires in 30 days. It must be kept in the original bottle (the lid has a desiccant to combat humidity). Make sure you don’t keep it in the bathroom… Also, it is taken twice a day (as close to 12 hours apart as possible, without interrupting sleep), instead of once a day like warfarin.

Bottom Line: If I had a family member that had afib, and that their insurance would cover Pradaxa (or the cost is worth the time), I wouldn’t have a problem recommending it to them over warfarin.

Hirka T’Bawa PharmD.

Disclaimer: While I am a pharmacist, I’m not your or your grandfathers pharmacist. I am most likely not licensed in your state, and hell, I could be lying for all you know. You know what they say about free advice? If you’re really worried, go to your local pharmacy and ask to speak to the pharmacist. They can answer all your questions for you.
ETA: Oh, sorry for the late response, I actually saw this post after you posted it, but was at work and didn’t have time to respond as well as I would want to (plus saw on my phone). Then my birthday came and went, I totally forgot about it until I was reminded today about it. Hope the response was worth the wait.

#3

To late to Edit to Add:

I just noticed you said your grandfather had kidney issues? Have these resolved? Pradaxa is cleared from the body by the kidneys. If his kidneys aren’t the best, they have to adjust the dose on the medication. What dose and how is he taking Pradaxa?

#4

This is stopping a lot of docs in my hospital from using it, and it makes no sense to me. Yes, Vitamin K will reverse the effects of Coumadin, but it can take up to 24 hours to work so if someone has an acute bleed he still needs FFP. In that same 24 hours most of the Pradaxa is metabolized out.

Also, you can’t dialyze out Coumadin, so if you have to reverse somebody double-quick you actually have more options with Pradaxa.

It’s a terrific drug, and I wish they would hurry up and expand its indications (to DVT, at least). As far as I’m concerned my considerable training and expertise in managing Coumadin can’t become obsolete fast enough. (Whether it is appropriate for your grandfather, Lor213, is of course between him and his doctor.)

#5

I agree, so far, everything shows it is better in almost all respects then warfarin… There is only one sector that warfarin is better… and that is cost. There was a study I read awhile back based in the UK (with their government healthcare) that showed that warfarin is still a cheaper drug, including both the monitoring and the drug itself, then Pradaxa.

I honestly don’t think the lack of reversal agent is that big a deal, as you said, if something bad happens, there are just as many ways to treat as with warfarin.

There was only one thing that make me question when I read the studies on Pradaxa. The concurrent use of a PPI (Nexium, Prilosec, Omeprazole, etc), wasn’t accounted for in any of the studies they performed. Since the drug requires an acidic environment, the concurrent use of a PPI scares me… And since the drug isn’t monitored regularly, if someone does use a PPI or regular antacid use, there might not be a way to tell until someone has an adverse effect (stroke, MI, etc).

#6

Thank you for all the great information! My grandfather does have AFib but was never put on coumadin for it in the first place. I guess at the time both him and his doctor decided that the risks outweighed the positive. 4 months after that conversation my grandfather had a massive stroke. I often wonder would the coumadin have helped more than the plavix he was on.

In September my grandfather went into kidney failure, they tell us it was caused by an auto-immune disorder. With fluids and steroids he’s not been cleared of the kidney failure and the kidneys are working better than they had been earlier in the year.

I believe the dosage he has been prescribed is 75mg twice daily. He is also taking Prevacid daily to prevent acid reflux as he has a G-Tube. My grandpa has a very complicated medical history since the stroke in 2010, basically the docs say he should have never survived it.

I’m not too worried about the reversal agent issue. Back in January he had to have his gallbladder removed as it went septic and nearly killed him, he’s been through A LOT in the past 22 months, and it took two days to get his blood thick enough to do the surgery because of the coumadin. He had to get a couple units of blood and all that so we know what it’s like.