Coumadin vs Warfarin and INR's

[epiontek]

I had my Aortic valve replaced 8 weeks ago and wanted to share my surgeons thoughts/opinions after seeing him recently for a post-op check up.
First I had some problems with bleeding around 3 weeks after surgery. It was determined after a contrast CT and visits to the ER and a Urologist, that my body needed time to get used to the Warfarin. During this my INR's were all over the scale, as high as 4.6, as low as 1.6.
After sharing this info with my surgeon he first called the Cardiologist's office who is managing my INR level and instructed them I should be at 2.5 period. None of this "range" stuff which he believe's causes these Practitioners to vary the doses too much.
Second, he insisted I switch to Coumadin, not Warfarin, because believes Warfarin can very from dose to dose as some generic drugs can.
I share this in case others out there may have, or may be having similar issues.
All I can say is I'm going great and haven't had any bleeding for about 4 weeks.

 

[ALCapshaw2]

FWIW, I switched from Coumadin to generic Warfarin (made by TARO in Israel) after my insurance coverage changed to only pay at the generic rate. I had NO problems with variation due to being on warfarin. BARR is another generic manufacturer with a good reputation.

Have you read Al Lodwick's website (www.warfarinfo.com)?
Do you have a copy of his manual for dosing anagement?

If your answers are NO, I highly recommend you read his site, get his book and dosing guide, and compare those recommendations with your Coumadin Manager. Unfortunately, NOT ALL managers understand how to prevent wild swings (by using SMALL dose changes spaced over several days to allow your body to stabilize).

(and yes, it can take a few weeks or maybe even months, to stabilize in some cases, following surgery).

'AL'

 

[Guest]

I would venture a guess that the person who says 2.5 period has very little experience managing warfarin. It is actually these people who make most of the dosage changes because they don't know what they are doing. If you tolerate the INR being within a range then you do not make many dosage changes. This qualifies for my webpage about the most outrageous advice give to warfarin patients.

First of all, the machines that do the testing are not all that accurate. If this person knew that, they would never make such a statement. If you ran three tests and got 2.3, 2.5 and 2.7 (all within the margin of error) what would this person recommend?

Next think of your body as a bucket with a hole in the bottom. Every day you fill it up with water (sometimes you may add more water than other days)and every day you dump in a little warfarin. Then you dump in foods that may decrease the warfarin level, medicines that may increase or decrease the warfarin level, and vary the amount of stirring that you do (= to exercise). Now tell me that no matter what time of the day or night that you test with an inaccurate machine that you will always find exactly the same (2.5) amount of warfarin in your body.

I'll bet that this same doctor would never consider driving cross country and stopping at every gas station to be sure that the tank remained on half full.

I'd bail out on this doc if I were you.

 

[Harpoon]

I'll second what Al said...


I've been taking the Barr manufactured warfarin for almost 2 years now, roughly, and the "problems" I've had with an unstable INR have always been either from picking up colds and or changes in my other medications (mainly amiodarone which I went off of a year or so ago)


I use one pharmacy exclusively (Ekhards) and they've always stocked the Barr manufactured generic. I was on the brand Coumadin for a while when I first left the hospital after surgery, but switched to the generic when the bottle of Coumadin I had gotten from the hospital's pharmacy ran out.

For the record, I have a target "range" as specified by my cardiologist of between 3.0 and 4.0 with a wee little leeway if it's only a few tenths of a point over/under.

I was a 5.0 once, when I went off the amiodarone, that's as far off the mark as I've been.

 

[epiontek]

Let me clarify something. My surgeon, whom I respect very much, I believe
told these NP's who are in charge of managing my INR 2.5 to prevent them from raising my INR too high and causing the bleeding problems again. ( which I wrote to you personally about Al after viewing your website)
He actually told me 2.5 - 3.0 was acceptable, but there was no need for me to be above 3.0.
His reasoning given to me was first because it was an Aortic, not a Mitral and second, he was able to use the largest St. Jude valve made.
f.y.i. - This surgeon came from the Mayo Clinic after a two year fellowship on strictly valve replacement. So his credentials are top notch.

 

[John & Joann]

Cleveland Clinic has recommended that Joann NOT take the generic coumadin. Their reason is that since she is high risk, they do not want to take a chance on ANYTHING. Since our drug provider (Caremark) does not always use the same generic medication, the quality control between manufacture company will vary. Barr is generally regarded as high quality and consistent, but others are not.

Coumadin was made by Dupont for many years. When they dropped out of the drug business the product was purchased by Bristol Myers Squibb. As far as we know, the product is still manufactured in the same facility.

Most people will do fine on the generic, but 2 valves, atrial fib/flutter, TIA's and 1 stroke are not worth the risk. This costs us big $$$$ from our favorite company Caremark (Formerly Advanced PCS). The worlds worst company for communications.

 

[Ross]

I'm not trying to sway what you surgeon told you, but 2.5 to 3.0 is almost impossible to maintain. The window is so tiny that you'd be going insane trying to keep it there. 2.5 to 3.5 is more realistic. I home test and I don't get upset unless I'm higher then 4.0 or lower then 2.0. The difference is so very tiny. With years of experience with your INR, you'll see what we mean.

One more thing-Most often the professionals that we count on to know this stuff actually know very little and in some cases, nothing at all about Coumadin management. We see it day in and day out here on the forums.

 

[Granbonny]

I have been on warfarin, by Barr. from Eckerds drug store (Like Harpoon) ..now for 2 1/2 years. My INR is ALWAYS in range..My Cardiologist wants it to be 2.5-3.5..I home-test and call into his office, once a month. I have the mech valve .Aortic ....St. Jude's.......23..... Shortly after my surgery, my gums started bleeding. Went to dentist and have been going now every 4-6 months....Now, never bleeds. I was very slack about cleanings before my surgery.... Very important to go to your dentist, now..for a good cleaning so gums will not bleed...Also, 10 months after my surgery, I had blood in Urine. Went to Er. INR..normal. Just a strange thing. UTI...(could have happen if I had not been on coumadin)Never had one before. but, I thought it was because of warfarin. ER doctor said no..and it was gone the next day..after a dose of antibodies. ..No problems now for almost 2 years. I never bleed, bruise, ect....... Just had my 6 month checkup with Cardiologist (He still likes for me to come every 6 months..everything was good, including my yearly echo.... Bonnie

 

[Guest]

Surgeons cut.

For the most part, they are miserable at making decisions about medications. Most do not even manage pain medications very well after surgery. Some of the most ridiculous things that I have ever heard about warfarin were said by heads of surgery departments at major universities. I gave depositions against some of these guys and was prepared to go to court against them.

The American College of Chest Physicians sets the guidelines for use of warfarin. They say that 2.0 to 3.0 is acceptable for bileaflet mechanical valves in the aortic position. As far as I know, there has never been a study showing that the size of the valve makes any difference.

I do know that the people whose doctors set the narrowest ranges are the ones who get the most dosage changes - at least in my clinic.

There has never been a study published that showed that switching between different generics made any difference. In fact, there have been some that showed that it made no difference. I have no quarrel with someone who wants to pay more (or can convince their insurance company to pay more), but to say that it is done to prevent variation is just not borne out by studies. A few years ago, Israel switched the entire country to generic warfarin made by Taro, because it is an Iraeli company. The major outcome was that it harmed nobody.

A few years ago when DuPont was still making Coumadin the marketing department had a big push to convinvce doctors that switching brands was bad? They convinced many doctors but then they lost a huge lawsuit because the FDA said that all of the generics met the same standards. DuPont was paying me big bucks to give talks for them but, when I wouldn't say that Coumadin was better because the studies were starting to come in saying that there was no difference, I lost the contracts because I would not just be their shill. I still have the slide set that I was supposed to use. It seems almost comical now.

I have thought about putting advertising on my website, but decided that I wanted to be free to tell the truth, not be threatened by having they money withdrawn. I could be richer but I feel good about being a voice for truth.

 

[Johnny Stephens]

Have switched back and forth between Barr warfarin and Coumadin twice in the 2 1/2 years since my surgery. I never did see any unusual readings that stood out when compared to the long periods on one or the other.

Regarding the range - mine is 3.0 to 4.0, with 3.5 being the target. I tested 2.9 yesterday, so by strict interpretation, I'm .6 off from the 3.5 ideal. I'm lucky in that my anti-coagulation specialist has a clue, so no dosage changes were made, and I avoid chasing my tail.

YMMV

 

[epiontek]

In my 15 years as a Paramedic I know for a fact that in some people some generic drugs did not work for them as well as the name brand. I know because they've told me. Maybe not in the case of Coumadin vs Warfarin, I don't know. Bottom line is one person's body might react differently than another's.

 

[Ross]

I've mixed and matched, used one or the other, and never ever saw a bit of difference except price. Coumadin, Taro and Barr, made no difference whatsoever.

 

[Guest]

I was thinking more about this and recalled that I used to tell people that you should never switch from Coumadin. But that was pre-1997. By 1998 the evidence was pretty well in that there was no difference between warfarin and Coumadin.

Don't forget that insurance companies are in business to make money. If they found out that switching from brand to generic warfarin cost them a fee for even one more lab test per person, they would immediately insist on going back to the brand.

I recall an incident when I was a brand new pharmacist. A lady came in for a refill of her prednisone. I couldn't find any from the manufacturer that she had gotten before. So I filled it with what I could find. I wrote the name of the manufacturer I used on the back of the prescription. Three days later she was back wanting to see the owner of the store. "Bill, these pills he (pointing to me) are no good. I want the one like I got before." Bill looked up the prescription. Unbeknownst to me the company had changed names recently. Bill knew they were the same, but he told her that he would change them. He gave her the same pills back plus 3 to replace those she had taken. For the rest of the time I worked in the store she would not let me fill her prescriptions, always reminding me that Bill knew best. So if Bill wasn't around she would just wait until he came back from lunch or whatever.

In the early days there were a lot of schlock generics. I saw one bottle of 1000 iron pills when I was in the army that wouldn't pour out of the bottle. They were just a big lump. We chipped the bottle off from around them and had them sitting on a desk for a long time. It looked like a modern sculpture. Another time we found a bottle that must have benn the last one of the day, where they swept the floor and put the swept up pills in the bottle. There were broom straws and other bits of trash, too. But that was in the 1960s. They all meet the same standards today and wouldn't dare face the lawsuits that would result if they were one dab of difference.

 

[tobagotwo]

Al knows warfarin and Coumadin. If I were on ACT, I would trust him with my INR.

There is no question that certain types of generic drugs do not actually match the perfomance of brand name products. Frequently, it has to do with what else is in the pill, more than the main ingredient. The requirement from the FDA is that the amount and potency of the drug match the original, not that it be delivered in a smooth curve over the course of the drug's absorption, as the original often is.

For many things, it doesn't matter to the vast majority of people. Aspirin, for instance. Ibuprofen. Various new antacid products (like rantidine) and cold remedies (pseudoephedrine hydrochloride and similar ingredients). Almost no one could tell the difference between the original and a generic. Apparently, this is the case with warfarin/Coumadin as well.

For a few things, like blood pressure medicine, it can matter a great deal to some people, and not affect others at all. The active ingredient is always the same, but the bonding and carrying agents may not be the same, so drug strength may spike high shortly after taking it, and go quite low later in some instances. Or absorption may be more affected by things like what kinds of foods you like to eat around pill-taking time.

If you're using a generic for blood pressure, and it works for you, you're fine: no issue. If it doesn't work for you, you may have some significant problems up front. If you do, switching between generic brands is likely to affect you as well.

The appearance is that delivery management of the active ingredient is the biggest predictor of a generic's compatibility, when there is an issue.

However, Coumadin is for anticoagulation, which is different. I don't know warfarin's metabolization cycle, but it may not require even levels of warfarin in the body at all times to produce even results (ignoring outside influences like food, illness, or activity levels), or it may metabolize at relatively fixed levels regardless of short-term volume fluctuations.

I think I have read in VR (was it Ross? Harpoon?) that there can be a three-day wait for dosage changes to affect the INR, which I would guess leans either toward a relatively stable absorption rate, or a long cause-and-effect cycle.

Best wishes,

 

[Guest]

The classic example of a generic being different from the brand is Dilantin. This was discovered more than 50 years ago. They had no idea about how fillers could affect absorption. The symptoms of too much Dilantin (phenytoin) are similar to being drunk. When the generic came out people were staggering around, slurring their words etc. Come to find out the original brand, Dilantin was very poorly absorbed because of the things they put in it to stick the stuff together. The generics were so much better absorbed that people's blood levels were too high. They actually had to make a new category of phenytoin for the generic because they were so different.

Many of these ideas about non-equivalence were no more than figments of the oimagination of the marketing departments, however, The drug companies had fleets of lobbyists pressuring the state legislatures to require that there could be no substitution. (It was just like the battle now over importing drugs from Canada - little science and lots of hot air.) The used the Dilantin example to pressure (read wine and dine) state legislators to pass anti-substitution laws. I remember that in Illinois the battle came down to, "Are you opposed to the repeal of the anti-substitution amendment?" The idea seemed to be keep you so confused that you didn't know wehther you wanted generics or not.

 

[Marty]

Deja vue...all over again! I too was told by my cardiologist that his patients who took Coumadin were always a steady 3.0 but if they took generic Barr they were " all over the place". I even argued with Al about this the first time I met him here at a meeting in Washington in 1998. However I experimented with a friend ,Richard ,who likes to save money ( with same cardiologist, mechanical aortic valve). Switched him to Taro generic, tested every week with Coaguchek and he never wavered. Then I finally tried the Taro and tested each week and stayed 3.0-3.2.. Finally I was convinced Al is right. However I still went back to Coumadin. I am comfortable with the shape and color of the pills and they only cost 20 cents a piece more at my pharmacy.

Al take it easy on that poor surgeon, we all know they are not too bright but they are good with their hands.

I personally havn't found any doctors that really understand anticoagulation except for the hematologists. That's why at mid-Atlantic Kaiser( 600,000 patients) the warfarin patients are managed by pharmacists like Al. They use generics well and save big bucks.

 

[Guest]

Did you get the Institutional Review Board to OK the human experimentation?

 

[Brian]

Coumadin VS Generic Warafin

Coumadin VS Generic Warafin

I switched to Coumadin from warafin about 5 or 6 months ago. Before that my INR was all over the place, I thought for sure the Coumadin was the answer. I was more concerned with the increasing rate that I was having to up my doseages to. Honestly, I am thinking it is just the time that it takes your body to get all settled into this new way of life. I am still on 10 mg of Coumadin/day..the odd day I have to up it and the odd time I have to reduce it. Ross is right on the money when he says..if you are trying to keep it right to the number, it will drive you crazy. Just try to maintain it with in a range and you'll live your life a whole lot easier. I also take Cod Liver Oil and Salmon oil daily hoping that it will help raise my INR so I don't have to take so much rat poison...it doesn't seem to help..but then again the oils are heart healthy products..so I'll keep taking them anyway. I also make sure I eat vitamine K rich food each day (at least a little) Bocolli, brussell sprouts, etc..their good for us and we can't omit them. I treat them like my daily drug (Coumadin) doseages.
In a nutshell, THANK GOD for the company and or People who developed the home testing equipment. I have a CoaguChek S monitor and couldn't be with out it.

Good health to you all,
Brian

 

[ccrawford]

Bear in mind the docs are influenced somewhat by the sales reps that call on them. Naturally, some of them will swear the the generics are not the same dosage/reliability/etc as the original. I've been on Warfarin for about 6 months and like many others, have noticed absolutely no difference except for the cost. My insurer must really like Warfarin because I can get a three months supply for less than I used to pay for a one months supply. Hope this helps, Chris

 

[Brian]

Cheap is good.

Cheap is good.

actually up here in Canada, I haven't found that the Coumadin is all that much more than the generic..just a few bucks more for a bottle..never the less, warafin of any kind is one of the cheapest drugs out there..I can't think of too many other drugs that a person could take that is 64 cents per day..LOL.. and is so needed to sustain life.
Most of all metabolism is the biggest player in this game I am finding out.