Antidote Drug For Newer Anticoagulants Is Denied FDA Approval

In mid-August 2016 the US FDA rejected Portola Pharmaceutical’s application to market AndexXa (andexanet alfa) as an antidote to these three direct Factor Xa inhibitors. (Eliquis, Xarelto, and Savaysa)

AndexXa is being developed for patients being treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Factor Xa plays a key role in blood coagulation.

The FDA also sought additional information related to manufacturing of the drug.

What does this mean?  Well, it is unfortunate, as many patients are now treated with these newer anticoagulants. It means that they continue to take them at their own risk.  For warfarin patients, it means nothing has changed.  Be fortunate that IF you experience any bleeding, warfarin has a reversal agent, Vitamin K, that can help tremendously.

At the present time it is unknown when Portola will be in a position to resubmit its AndexXa application to the FDA, much less when the FDA will make its next determination about AndexXa being approved, or not.

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Medication mishaps

What most people don’t realize is that there are many medications that can interact with warfarin.  Most providers don’t tell their patients, let alone, they don’t realize it either.  It is one of the biggest factors that affect your INR. (remember, the INR is that “magic number” that helps your provider dose your warfarin)  I can’t ever blame my patients when they don’t notify me, if they never knew to do so in the first place.  There are so many medications such as heart meds, thyroid meds, antidepressants, antibiotics, cancer products, steroids, antifungals, cold meds, and more, that can affect the INR. Too many to list in fact.  It is my job to inform patients what to do if they have a medicine change.  You are not at all responsible for knowing.

I always tell my patients to let me know when they have new medications added or deleted, if they want to take something over-the-counter, or if their doses change. I know…this seems like a pain in the you know what, BUT…trust me on this…it will save you time in the long run, and most importantly, it really boils down to your safety.  When I find out about medicine changes AFTER they occur (for example, a patient calls 4 days into starting an antibiotic), I kindly remind them to always call with medicine changes. That simple.

Here’s an example of a common scenario:  patient Jill Smith is ill and gets diagnosed with a urinary tract infection  Her primary care doctor starts her on Ciprofloxacin for 7 days.  If I knew that from the start, I would most likely empirically lower her weekly warfarin dose while she takes the antibiotic. I will also ask her to “add” a warfarin blood draw while on the antibiotic, to see the effect of the medicine. Let’s talk about the opposite situation: patient Jill Smith is ill and gets diagnosed with a urinary tract infection  Her primary care doctor starts her on Ciprofloxacin for 7 days.  No one alerts me and she coincidentally has an INR drawn 5 days later. (or maybe she doesn’t even have a blood draw until after she is done with the Cipro which is dangerous because no one ever would know what her INR was running)  The INR comes back 5.0, which is critically high, and can cause her to bleed. I will still adjust her dose, but she unknowingly put herself at risk for a dangerous situation.

This is  a learning process but once you know this fact, you can coordinate with your provider on who will notify the person who is managing your warfarin/INRs.  I tell my patients to always call me themselves, as I’d rather have 2 people notify me (the patient and the provider), rather than no one.  I try to put the responsibility back in the hands of the patient!

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Warfarin is Rat poison!

I hear this statement at least a few times a week, whether it be from a patient that is already on warfarin or from a new patient that is not yet on it.  Usually it is in the form of “I don’t want to take that rat poison! My friend takes it etc etc etc…”  So, what do I do with that?  I have to admit, sometimes I chuckle inside, but at the same time, I understand what they mean and where they are coming from.  I try to explain a little about warfarin and how it became…

According to Wikipedia: “Warfarin was initially introduced in 1948 as a pesticide against rats and mice and is still used for this purpose, although more potent poisons have since been developed. In the early 1950s, warfarin was found to be effective and relatively safe for preventing thrombosis and thromboembolism in many disorders. It was approved for use as a medication in 1954, and has remained popular ever since. Warfarin is the most widely prescribed oral anticoagulant drug in North America.

Warfarin is a synthetic derivative of dicoumariol. Dicoumarol is a natural chemical substance of combined plant and fungal origin. It is a derivative of coumarin, a bitter-tasting but sweet-smelling substance made by plants that does not itself affect coagulation, but which is (classically) transformed in mouldy feeds or silages by a number of species of fungi, into active dicoumarol. Dicoumarol does affect coagulation, and was discovered in mouldy wet sweet-clover hay, as the cause of a naturally occurring bleeding disease in cattle.”

Ok, so maybe it still doesn’t sound so great, but if you keep reading, and I keep explaining, I then turn it into all the positives things that warfarin can do and what a great accidental finding it was back then.  Most of the time, the risks of NOT taking it far outweigh the risks of taking it.  After reviewing my patient’s case in detail, they come to a better understanding of why they require anticoagulation, and hence, warfarin, in their instance.

I think the moral of the story is not to jump too high when you hear what warfarin is or what it is about. We providers and medical professionals would not treat patients with it if it were actually “poison.”  Think of it as a good poison, in order for you to potentially prolong your life!!!

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Warfarin vs. New anticoagulants?

In my office, when a patient comes to me for the first time, it is my job to try to “steer” them in the right direction in regards to which anticoagulant they should choose to go on.  I always tell them I am only a “guide” but can’t/won’t make the decision for them.  I go through the agents that we have on formulary and the pros and cons of each. It can take some time, as I like to hit the highlights of each agent, and there are many.  Some patients end up staying on aspirin only, some start warfarin, and some start the new anticoagulants. (I am not going to get into why someone would choose which agent on this post)

Warfarin is highly effective for the prevention and/or treatment of most thrombotic disease, but the significant interpatient and intrapatient variability in dose-response, the narrow therapeutic index, and the numerous drug and dietary interactions associated with it have led clinicians, patients, and investigators to search for alternative agents. As of this post, there are four new orally administered anticoagulants. (apixaban, dabigatran, rivaroxaban, and edoxaban)  I have experience with the first 3, as the last one is not on formulary yet.

I always dread the question “What would you do if you were me?” Of course, I try not to answer that, as I don’t want to sway my patients in one direction or the other.  Most of the time, I can give an honest opinion about what agent would be the best option for them. There are many things a practitioner needs to consider when helping a patient choose the appropriate agent for them.  Things to think about are their medical conditions, current medications they take,  their clotting and bleeding risks, compliance with taking medications, ability to get to a lab for draws, intellectual capacity, family support, are they able to see visually, and the list goes on…

So, I guess I am trying to say is that in my world, it’s not a one stop shop for getting warfarin. I DO prescribe other agents. Each one has its place and there are good and bad things about both.  But, I will look at your individual situation/case and derive the best choice for you along with your opinions. Always question your provider if he or she only presents one option for you, as in most cases, there is more than one option!

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Communication is key!!!

Many of my posts will be related to my personal experiences at work.  Day in and day out, I encounter various situations that are very important to warfarin management and success.  I see many patients during the course of a week, so these particular situations arise over and over. One important aspect of your management is for your provider to be able to get a hold of you.  What I mean is, the ability for them to speak to you live or leave you a voicemail message.  Why is this so important you may ask? Your doctor’s office needs to contact you (most likely via phone) when your INR (remember, your INR is that magic number that tells your provider how to dose your warfarin) is out of range.  If they can’t reach you, it may be dangerous to you. For example, let’s say your INR comes back high at 5.0. Your normal range is between 2 and 3. This constitutes a “high” INR.  This means that your blood is on the “thinner” side. Most likely your dosing instructions will start off with, “hold your dose this evening,” meaning don’t take it this evening. If there is no way of reaching you successfully, you would not get these instructions and therefore, would take your warfarin as directed. Your INR may be even higher if that is done. Also, you have the potential for bleeding.

My simple advice to you is this:

#1-make sure you have an answering machine on your home phone and/or cell phone.

#2-make sure you know how to take off your messages from your machine.  You’d  be surprised how many of my patients tell me they have an answering machine but that they don’t know how to use it.

#3-If you have no answering machine or do not know how to use it AND your provider has not reached you live to discuss your results, call your provider’s office after EACH INR, for your results.  Many times they will be normal, but this eliminates you missing an “out-of-range” result, and hence, and potential problem.

I usually will try to reach a patient a few times, but I know with my personal situation, I make about 50 calls per day, and no offense, I don’t have time to continue to call a patient over and over to try to reach them.

Remember, communication is key in regards to your successful warfarin management.

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Welcome to Warfarin Warrior!

Hi Warriors,

It is I, your Master Warrior, Andrea. I am happy to finally be launching my site/programs. It took about a year to get up and running believe it or not. Proof that Warfarin isn’t a simple topic. It’s a very intricate subject that deserves special attention, especially if YOU take it.  Many of you have probably struggled with the strict “regimens” that come along with being on Warfarin.  And a lot of you probably have no idea what I’m even talking about.

What I mean is, there are many different topics that you must know about in order to safely benefit from Warfarin. Topics such as diet restrictions, medication interactions, how to dose it, what to do if you have a surgery/procedure, and many more. Don’t be scared!  This is where I come in. You are in the right place to gain a lot of knowledge about this drug that you take. A centralized place that can assist you with all of your needs and issues with Warfarin. It is a drug that should not be feared, it just deserves a little more of your attention is all.

Let me educate you and help you conquer any struggles that you are having with your Warfarin levels. Let me answer your questions that you have.  I look forward to getting to know you.  I also welcome any feedback, as I learn so much from my patients/clients.  I am here to take this journey with you so let’s begin…

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