Just seeking some guidance. I’ve been a member of this forum since 2014 and I can only ever recall seeing two very recent member references to black box warnings for anticoagulants in general and Apixaban in particular. This prompted me to type this header into the search box at the top of this page which produced nothing of any significance.
I’m currently in Portugal, so Google results are possibly different here than in the UK but similarly, nothing of any significance appeared. However, there was a fairly old reference to an American webpage called Drug Watch which said, “the Eliquis drug label comes with the following Black Box Warning: Premature discontinuation of any oral anticoagulant, including Eliquis, increases the risk of thrombotic events”
This is something I’ve always wondered about too, and I’ve asked doctors but got no clear reply.
Since I started on DOACs in 2016, the patient leaflet that comes with the meds has always said something similar to what you quoted. It currently says: “Do not stop taking this medicine without talking to your doctor first, because the risk of developing a blood clot could be higher if you stop treatment too early.”
This is something that has always troubled me about taking a DOAC, not understanding if stopping it just puts me back to the increased clot risk I was in before I started taking it, or actually increases the risk greater than that. Is there a short rebound time or something of the sort?? Obviously for those of us on Apixaban permanently, there are times we might need to temporarily stop it, eg for procedure or due to a bleed etc… does this increase our risk of a clot more than if we weren’t taking it in the first place?
Sorry I’ve no answers, just questions- and I’m hoping someone in the know can cast some light on it! Jx
Me too! It’s a bit like the definition of the word spontaneous. Some suggest it means something that just happens for no reason but spontaneous applause doesn’t happen like that, something has to happen to prompt a load of people to start clapping at the same time. From what I have been told by people who know about these things is that spontaneous bleeds don’t happen for no reason either. A spontaneous bleed occurs when there has been a physical change somewhere in the anatomy which has caused the bleed to occur, not just because someone has taken a pill with a glass of water……as you say, hopefully others will cast some light on it 🤞
Yes flapjack, I’d like an answer to the spontaneous thing too! Can Apixaban actually cause a bleed, or just worsen a situation caused another way? I’ve had different replies from medics, be good to have some wisdom here
Yes, the risk is even increased shortly after stopping suddenly. I researched the whole thing when I was forced to quit taking any of them, as had bad reaction to all. And it seems there is an increased risk after stopping. Not just the risk you had before ever taking them, but worse. Same with Marcumar. So I quit my Marcumar slowly. Most doctors have never heard of the problem, but it is real. And of course, in most cases of people suffering a stroke after quitting Eliquis etc doctors will say it was the underlying condition, for which it was taken. Which is always a possibility. As far as I remember (it is 7 years ago in my case) there were few studies, but they existed. So I was careful.
The important expression ist rebound hypercoagulability. Which is like the rebound you get when getting off betablockers too fast. You are worse off than before, as new receptors have formed.
Wow, thank you so much nettecologne - you’ve answered something I thought I would never have a clear answer to! I really appreciate it, thank you! I will have a read.
It’s not what I hoped to discover, but it’s what I had assumed must be the case otherwise those warnings would not need to be there (as discontinuing any meds early will put you back to the same risk as before, the point here is the increased risk.
A black box warning – often referred to as simply a “boxed warning” – is the strongest warning issued by the FDA in the United States on drugs that carry specific health risks – serious or life-threatening adverse effects.
When a black-box warning is issued, it informs healthcare providers and prescribers of serious adverse effects of specific drugs and enhances their clinical judgment. For example: when atypical antipsychotics were assigned a black box warning for use in patients with dementia (as it increases the risk of death) – prescription use of antipsychotics for this population declined thereafter.
The same is true for many other medicines, too. For instance, when the antidiabetic drug – rosiglitazone – was issued a black box warning, use of that medicine declined by almost three-quarters. Prescribers seek alternative medicine choices to reduce any potential risk to the affected population.
Here, we have put together a list of black-box warnings that both prescribers and pharmacists must know. Bear in mind that this is not intended to be a complete list of black box warnings.
Thanks Jean, I did find this page, it was interesting to see the only DOAC listed is Dabigatran and that’s only if injected into the spinal/epidural area and not used as a conventional anticoagulant apparently……
You have AF you have a five fold increased risk of thrombatic stroke. Anticoagulants reduce that risk by about 70%. . Obviously stopping anticoaguants for those at risk (i e those with AF) will increase stroke risk.
I don't recall the source but I have read/heard that stopping a DOAC does lead to an increased risk of a clot - not immediately but over the next 3 -6 months. So stopping for a few days for a procedure carries only a very slightly increased risk - but stopping taking it for good does expose you to an increased risk (unless the reason for taking the DOAC is no longer present).
But, of course, risk is a slippery thing to work with. Suppose it increased your risk by 5%, that wouldn't mean 1 in 20 people would have a problem - I'm not sure what it would mean!
What you are saying makes absolute sense. I am having a mini maze in the not too distant future hopefully.
When I had my initial consultation with Mr Hunter, he said that the aim is to get me off all meds including anticoagulants, 3-6 months after the operation.
I have wondered since why the delay, because as part of the surgery he clips off the left atrial appendage which is where clots form when you have AF.
I am assuming the delay is to ensure that any little clots that may have formed before or after the surgery, have cleared whilst still on the anticoagulants.
I note the wording is ‘stopping *prematurely* which suggests that you might be taking the anticoagulant to see you over an ablation and stopping before your heart has settled into NSR would increase the risk of clots. You might also be taking it after a procedure which leads to an increased risk of forming clots eg an orthopaedic operation and stopping before you had achieved full mobility would be dangerous. That’s how I read it anyway.
Yes, Buffafly, that’s kind of how I’ve been getting my head around it too! But for me it still leaves the question for those of us taking it for AF, where the clot risk doesn’t have an end date, as we are permanently in the situation of the DOAC being necessary, and any stopping of it would be ‘premature’. So I still wonder if the clot risk is increased additionally for a while after stopping them. (Additional to the risk I would have had if I hadn’t started them at all, I mean.)
I hope I’m making sense - but possibly only to myself!! Jx
My researches after being given Apixaban prior to a cardioversion led me to the following on the NHS website. It might assist as it shows some warnings highlighted within black boxes with regard to serious bleeds:
Hi FJ, I see you asked a similar question on healthunlocked.com/anticoag... forum and had no replies, it’s amazing how inactive some of the other forums/communities are compared to this one. For a minute I thought it was that post, then I realised you’ve posted on AF Association and got responses straight away. Just highlighting how helpful this forum really is.
On to my thoughts, the way I read it is that Apixaban won’t cause you to bleed but if something was to cause you to bleed from a trauma injury or weakness then you might bleed for longer than someone that was not on anticoagulant. My experience so far would back that thought up. I would take premature discontinuation as stopping the anticoagulant before the condition that raises your stroke risk is removed or cured. In other words, don’t stop until your doctor says to. Not an answer as such but just my understanding and thoughts.
When I was changed from Warfarin to Pradaxa, after having a couple of TIAs, I remember the stroke doc telling me that some of these did not have a antidote but that Pradaxa did, he also told me that I could only stay on this until I was 80.........silly me did not ask why and I shall be 80 next year! Knowing the way things are now with docs etc., I bet I am still on this drug for the duration, maybe I should ask questions. I can well imagine the consequences if you just stop taking anticoags, I have already had a stroke but that was prior to taking any and I have been taking them now for over 20 years.
I believe that with some anticoagulants the dose is reduced under certain conditions - I think with Apixaban it is two out of - over 80, under 60kg and serum creatinine over 133 (whatever that is, though I understand the first two.
I think that Pradaxa is dabigatran? Looking at the BNF it seems that the dose is reduced a little at age 75 and then reduced further at age 80 (in the UK). Regardless of other factors.
I have certainly read that same point many times and I have no doubt it is likely to be true, as any sudden withdrawal of a pharmaceutical is likely to have an effect as the body readjusts to 'normal' without the drug. It has always worried me about what would happen if I need medical intervention which causes blood loss as the usual recommendation is to abruptly stop the anticoagulant for some days before. If the warning is correct, that means a greater likelihood of clotting just at a time when under stress from a medical intervention such as surgery.
You don't have to worry that much here. Before my first hip op the anaesthetist took me off Apixaban for 8 days. The nurse came to the house twice a day to give me Lovenox jabs. These continued after the op for 2 days then I resumed the Apixaban. The only drag was the time she came in the morning as I live in the next village and was first on her rounds. Plus the black and blue abdomen from the jabs!
Thanks for that information. I had not realised that there was an option of another type of anticoagulant which would be less of a problem. The really scary thing I read, having had one hernia operation some years ago with the normal epidural in the spine, was that when on anticoagulants there was a real danger of bleeding into the spinal cord with resulting paralysis! Horror story! As so many ops are done in this way in France it just adds to my largely irrational worries. I hope the incidence of these things occurring is very low and they are fully aware of potential problems.
Sometimes it best not to read about all the possibilities! 🤣
I had a choice for both my hip replacement ops of GA or epidural. I chose GA as I am far too squeamish to want to hear what was going on! One of the benefits of being on an anticoag is not having to have a month of Lovenox jabs after a hip or knee replacement. My friend had to have that after her hip op. When I had my colectomy I was not on an anticoag and I had to have them for a fortnight post op.
I looked this up after seeing a post the other day. I think there was a leap to thinking that having taken the anticoagulants would increase the risk of clots overall.
I’m fairly sure it just means that you take them to prevent those clots, and if you stop them then you increase the risk of an event. Compared to taking them, not compared to your original risk.
in my opinion, I understand that the anticoagulant is taken to reduce a clot risk, however, if you stop taking them then I understood the risk is increased again (to pre anticoagulant state) as you are no longer taking something to affect the coagulation time of the blood. Right or wrong, I believe it puts the risk back to where you were before taking any. I don’t think stopping them increases the risks any more than were there before taking them in the first place?
This study-not specifically about Apixaban-suggests that stopping a DOAC returns the risk to its pre-DOAC level. There are a couple of quite technical issues which the paper refers to:
I was on a maintenance dose of rivaroxiban 10 mg after several blood clots in my leg ,then around 2021 my pacemaker picked up that I’d had several eoiof AF. The anticoagulant Dr was talking about stopping the medication. The cardiologist upped the dose to 20 mg and said that’s it your on anticoagulant for life. This week my pacemaker sent a scheduled download to the pacing clinic and shows no AF for over a year. I posed the question of do I still need to take the rivaroxiban. I am waiting for a reply from the cardiologist. This post now has me worried incase they say to stop the medication. I obviously don’t want yet another episode of blood clots as it’s caused a lot of long lasting damage to my leg or worse still a stroke.
Obviously you must be guided by your medics but the general thinking is that once diagnosed with AF, the risk of stroke remains, regardless of any treatment received . I don’t know if having a pacemaker makes any difference but I would doubt it but I’m not medically trained so important to follow the advice of those who are. Take care………
The warning is simply saying: 'You are on this medication because of your increased risk of clotting. Do not stop taking them unless that risk has been removed.'
What it is not saying is: 'If you take this drug for a while then stop, it will cause you to have a greater risk of clotting than you had before.'
Thank you all for your comments and replies. Clearly anticoagulation is a complex subject for many and the more you dig, the more complex it becomes.
My concern is, and always will be, for those who have just been diagnosed and join the forum to seek help and guidance. They are often afraid for their future and because, in the current climate, they might not get the help they should from their GP’s, let alone the incredible long wait they may have if they have been fortunate enough to have been referred to a specialist. In my opinion, making them more fearful than they already are is best avoided, but that shouldn’t prevent helpful and constructive discussion…..
A great post for the silent browsers and newbies to read of which I have been and still am to an extent. When I do respond it is always with the browsers in mind and not just the Original Poster (OP). And for anyone interested, every post brings up related posts on the right of the page or you can use the search bar at the top.
Flapjack? My new surgery told me that ‘Here’ we prescribe Edoxaban rather than Apixaban. It’s exactly the same, so is that alright with you?
I said yes, but since I have read that there is an antidote (in case of a very bad car crash for example) to help with clotting for Apixaban but not for Edoxaban.
Also, I am sure that, although of course I would bruise easily on Apixaban, my bruising is much worse on Edoxaban.
I’m going to ask to switch back but what do you think?
During all the fuss about the recent and ongoing switching to Edoxaban as a first choice anticoagulant by Health Commissioning Groups in many areas of UK, accompanied by the easy suggestion by some that AF patients were consequently being prescribed a cheaper and inferior anticoagulant, I was reassured to read this research from Germany published in 2022 ... pubmed.ncbi.nlm.nih.gov/347...
You will see from this research that Edoxaban reports lower risks of strokes (from clots) than all other DOACs and Warfarin, and equal low risks of brain bleeds (along with Apixaban).
These results seem to me "good news" re Edoxaban, although I have been warned by a.n.other that the big Pharma affiliations of the authors of such research do need to be examined more closely to assess any conflicts of interest.
I can’t really comment otherwise than to say I have only ever taken Apixaban and would not change 😉
Hi FlapJack I have been on Edoxaban for four years the anticoagulant of choice if you live in Scotland with no problems. It is similar to Apixaban. It motivates me not to increase my weight beyond 60kg when the dose of 20mg I take would be doubled.
I stopped taking it for a week before a shoulder replacement op and immediately was back on anticoagulant injection later on the day of op and then daily again.
It would depend on reason for being on Apixaban, Edoxaban but if for a standing condition there would be no need to stop except for before an op. As far as I know the anticoagulant action needs reactivated every day by taking a tablet. However, I’m not so sure there is an immediate antidote to their action in the event that would be needed. I take mine late on in the day with it in mind that its effects are waning during the time I might be most likely to cut myself or fall. But everybody lives with chance in life. I am grateful for every pharmaceutical I get.
I had an ablation 6 weeks ago and the Drs letter I got afterwards said they are reducing my evening dose of Sotalol and will eventually take me off it, but I would on Edoxaban for life.
Well, I’m already a ‘bleeder’ 🙄 put on Apixaban! To add insult to injury put in Dronedarone which it seems was NOT a good idea with Apixaban as it increases its effect!!
Consultant seemed to ignore the fact I’d replied I was on Apixaban😳 I cut the Apixaban in half and take only half x2 a day.
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