Adverse Events With Warfarin

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We have been putting data from my clinic on an Excel Spreadsheet for over four years. I have some pharmacy students who are doing chart reviews and we have enough data that I wanted to let you know what we have found.

We have had over 11,000 patient visits. There were just under 900 people involved. We had just about every reason that you could think of for taking warfarin. The ages ranged from 5 months to 107 years. So far we have reviewed about half os the charts and this is what we found.

At about 60% of the visits, the INR was in the desired range give or take 0.2 INR units.

There were about 460 patient years covered.

There was 1 episode of minor bleeding per patient year. In most studies, major bleeding is defined as life-threatening or requiring 2 units of blood to be transfused. We used this definition. Anything that required the person to stop what they were doing to attend to the bleeding up to a bleed that required 2 units of blood was defined as minor bleeding. For example, if someone blew their nose and there was a spot of blood on the handkerchief but no action was required, this did not constitute minor bleeding. But if someone woke up to find a spot of blood on the pillow case and they had to wash it, this was minor bleeding. Almost all minor bleeding was from the nose.

Clotting events occurred at the rate of 2 per 100 patient years. Most were minor clots in the legs. Most occurred when the INR was low when the person stopped warfarin. Most required no other treatment than re-starting warfarin.

There were 25 major events. These included strokes - both clotting and bleeding, one heart attack, gastrointestinal bleeds, bloody noses, etc. This is a rate of a little over 5 per 100 patient years. All but 4 of these events occurred in people who had serious conditions besides the one that caused them to be on warfarin. These conditions included being very frail, alcoholism, having heart failure caused by being hit by lightning, lupus, extreme anorexia causing the INR to be elevated at many visits etc. So when you look at people who had only one major condition, (heart valve, atrial fibrillation, uncomplicated blood clot in the leg etc) then major events - clotting or bleeding occurred less than once per 100 patient years.

There were three deaths - one was a suicide. That person had previously had a bleed into the knee joint and he felt it coming on again. He called a relative and said that he could not go through the pain again and shot himself. The deaths are understated, because when a person goes into hospice or is unable to go out of the house, I recommend that the warfarin be stopped unless they have a mechanical heart valve. I do this because I see little reason to anticoagulate a person who is near death. There is a good chance that they will stop eating causing the INR to increase and possibly bleed. If they have accepterd that death is near, then I think that it would be less traumatic to have occur from an unseen cause rather than bleeding. In fact, bleeding would probably cause them to go to the hospital and die there which is probably what they did not want.

I hope this helps reassure some of the people who are worrying about warfarin.
 
How Very intersting and reassuring for sure. Your a great asset to our group. Thank you for the continued support and information. Wish there were more educated professionals like yourself around the country:).
 
Absolutely wonderful, informative post, Al. Certainly puts things in perspective re. coumadin. Thank you so much for sharing.

Evelyn
 
Al,

Great data gathering!

Something to consider in my Advanced Directives. Never thought of Warfarin but was mostly concerned about other extrodinary measures.

So glad you keep us updated and informed about Warfain. This site is so conducive to keeping rational thoughts about VR and Warfain.

Donna
 
The data would mean nothing if it was not shared. After all it all came from people who have an interest in the subject. I am fortunate enough to be able to be a repository and interpreter.
 
So Al,

So Al,

Guess I should be all set now, huh?

The chance of lightning stricking me three times aren't in my favor which certainly makes me feel better.

This was very informative, and thanks to you and your staff for compiling and analyzing all of this data. You certainly are an asset to our group. Thanks!
 
Hi Al-

Thanks for sharing your study. That is what makes this site so wonderful. It gives us all the sum of each person's knowledge, multiplying it. It's the true meaning of synergism.
 
Al,

Your contributions are most appreciated. It is wonderful to have all of these anectodal and personal responses (usually from a sample of 1). However, your scientific approach provides a whole other and highly valued dimension.

As a new member of the Coumadin club (8 mg a day) for my new Carbomedics aortic valve - your work and findings are most welcome. :)

Harvey

Bicuspid aortic Valve Replacement
QE II Medical Center - Dr. Idris Ali
Halifax, Nova Scotia
Carbomedics Mechanical Valve
March 26, 2003
 
Well, Al, I wasn't worried, and after reading this, I'm even more not worried! :D

Very interesting reading. Thanks for posting!
 
Thank you, Al!!

Thank you, Al!!

I truly appreciate all the information you have provided. You?ve been a great help to all of us.

Has Perry and Gina talked you into going to Chicago yet? Not just to be a speaker..... you?re a part of this vr.com family too. We just wanna give you a hug and have a drink with you!!
 
Interesting Data!

Interesting Data!

Al, You are collecting some very interesting data. I can't remember reading anything like this before. Are you aware of any similar studies in the "thrombosis" literature? Are you going to present it at the AC Forum? I think the JAMA or Annals of Internal Medicine might give it a good look. Somebody like Dr. Ansell might help you get it published.
 
I am going to the AC Forum meeting on Thursday. I plan on talking to Dr. Ansell then.

Thanks for the encouragement.
 
Hi Al
I looking for advise on my wafarin. I have alot of trouble keeping in the range they want it. I go from 1.2 one week to 4.2 this week. I notice today that I have alot of little pin size reds dots all over my legs. I am on 5 mg. every day. I have been on this since last Jan. 2002. I am really concern. Does anyone know what can cause this. Thanks for any help.
Sherrin Hutt
Valve repalcement 2002
 
Rain, tell Sherrin about the red dots.

Sherrin, if you never vary your dose from 5 mg and your INR goes down to 1.2, then you are doing something that is inconsistent. Keep a diary of what you eat and do:
Food
Exercise
Other medications - especially something that you do not take every day.
Alcohol
Water retention

Your liver is what metabolizes the warfarin. You have to be doing something that affects vitamin k or your liver.
 
HI Rain,
Thanks for the infor. My daily routine and diet are pretty much the same every day. I have been under alot of stress lately. I don't drink and have no fluid retention. I was at my primary Dr. last wed. and this showed up yesterday. I have liver problems in the past. Thanks again.
Sherrin
 
Petechiae!!

Petechiae!!

Hey Al,

Your wife must be a pretty cool lady if she?s from Chicago. I?ve found that a lot of my favorite people are from there!! I can?t wait to meet her. :)

Sherrin, thanks to my favorite pharmacist and doctor here at vr.com I just happen to know those little red spots are called ?Petechiae?. :p I have found them to be a pretty good indicator of when my INR is over about 4.0. They seem pretty harmless... they always start around my ankles, but have made their way all the way to my chest before! Little red spots = Time to check your INR!! :eek:

If your INR is fluctuating that much, you really need to keep a diary ... like Al said. And in the end you may find that it all boils down to whether your dog is sleeping in the flower bed or not!! :confused:

Stress is bad news. I think if we could figure out how to get rid of the stress in our lives and keep a positive attitude about everything we would feel 100 % better. I know that is next to impossible... but hey, Sherrin.... I?m sending you some really positive vibes and best wishes. :) Let me know if I can help.
 
Red dots!

Red dots!

Well well well. My INR was a bit on the high side last week. 4.0 ish. Thought my usual adjustments took care of it. 3 days ago the little red dots appeared on the inside of my ankles. This has only happened to me a few times when on my feet for a prolonged periods of time. (which I have been doing a lot of as late).

Will recheck on wednesday. Have been eating a few salads between so I should be fine.
Thanks for the info Rain!
 
Rain, do the red dots go up and down like a thermometer? The higher the INR the higher they are on your body. Maybe you could save money on test strips.

Speaking of rain, we have had 4 inches in Pueblo so far this year. That is 1 inch more than we had in all of 2002.
 
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