Jan 12 - The bleeds just keep on comin

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Anonymous

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From Heartwire
US Bleeding ADRs Higher With Dabigatran Than Warfarin
Sue Hughes

January 12, 2012 (Horsham, Pennsylvania) — Concerns about bleeding with dabigatran (Pradaxa, Boehringer Ingelheim) continue, with a new report that adverse drug reactions (ADRs) involving hemorrhage reported to the US FDA were higher for the new oral anticoagulant than for warfarin in the first quarter of 2011 [1]. Many of the bleeding events with dabigatran involved intracranial hemorrhage in elderly patients.

The report is from QuarterWatch, a program from the Institute of Safe Medication Practices that monitors all serious, disabling, and fatal adverse drug events reported to the FDA through its MedWatch reporting program.

The latest data show that there were 505 reports of hemorrhage with dabigatran in the first quarter of 2011, which QuarterWatch says is "more than any other monitored drug, including warfarin, which ranked second, with 176 cases of hemorrhage."
 




I read a blog recently where the Dr. was discussing the fact that many warfarin bleeds are not reported, because they are expected and there is no rep. in constant contact with Dr's to report them. Most people who are in the know are aware that this would be skewed. It would be more interesting to see about Pradaxa relative to the factor Xa inhibitors, but we will have to wait a year for that.
 








It's not fair that those generic warfarin reps don't call into their ADR numbers the adverse events that occur on warfarin. Ohh, wait a minute there aren't any. Hmmm. Go figure an anticoagulant causes bleeding, I never would have guessed.
 




Anonymous said:
It's not fair that those generic warfarin reps don't call into their ADR numbers the adverse events that occur on warfarin. Ohh, wait a minute there aren't any. Hmmm. Go figure an anticoagulant causes bleeding, I never would have guessed.
Click to expand...

It's amazing, and incredibly sad, how callous you are towards a serious adverse event that could have significant negative impact, including death, on a patient and their family. I'm sorry your bonus check and enormous ego have created as much narcissistic tunnel vision as they have, you really are a pathetic boob and your ignorance of the reality of anticoagulant treatment makes everyone who promotes meds look stupid.
 




Anonymous said:
It's amazing, and incredibly sad, how callous you are towards a serious adverse event that could have significant negative impact, including death, on a patient and their family. I'm sorry your bonus check and enormous ego have created as much narcissistic tunnel vision as they have, you really are a pathetic boob and your ignorance of the reality of anticoagulant treatment makes everyone who promotes meds look stupid.
Click to expand...

It's amazing how you really think I am "sad and callous". I get it on the level of people, having a stroke, ich, death is a pretty shitty event. But maybe you could re-read the post slowly and let it sink in that their is a reason that ADR's for dabi will be at a level quite higher than expected: that is because reps are out there actively doing their job and reporting any "weird" or "maybe weird" phenomonon on to BI because they care enough to report every little or big thing about the drug. this is the way Bi trains its reps and should be commended. The fact that this drug would have such high ADRs should be tempered by the fact that NO OTHER COMPANY IS DOING THIS!!! Do you get it now? or should I spend some more time explaining quite clearly that we docs do NOT call in adverse drug events when we have a little ol' lady come in my office with hematuria due to warfarin. I just bump dose and move on. Dabi is an anticoagulant and if NOT USED CORRECTLY you will get some bad results. Hell, even when it IS USED CORRECTLY you should expect to find bad results. It's the nature of the game. I merely think it's shameful someone would start this post with a tagline about "bleeds keep coming" and NOT place things into proper perspective. I really don't expect much from reps but I do expect a small modicum of decency about this especially when you and I both know that little old Bonnie will just read your shameful post and repeat it on to her bridge club members and a bad spiral ensues. As long as you dumb reps put up hideous posts, I will knock 'em down like Babe Ruth. Capiche?
 




Anonymous said:
It's amazing how you really think I am "sad and callous". I get it on the level of people, having a stroke, ich, death is a pretty shitty event. But maybe you could re-read the post slowly and let it sink in that their is a reason that ADR's for dabi will be at a level quite higher than expected: that is because reps are out there actively doing their job and reporting any "weird" or "maybe weird" phenomonon on to BI because they care enough to report every little or big thing about the drug. this is the way Bi trains its reps and should be commended. The fact that this drug would have such high ADRs should be tempered by the fact that NO OTHER COMPANY IS DOING THIS!!! Do you get it now? or should I spend some more time explaining quite clearly that we docs do NOT call in adverse drug events when we have a little ol' lady come in my office with hematuria due to warfarin. I just bump dose and move on. Dabi is an anticoagulant and if NOT USED CORRECTLY you will get some bad results. Hell, even when it IS USED CORRECTLY you should expect to find bad results. It's the nature of the game. I merely think it's shameful someone would start this post with a tagline about "bleeds keep coming" and NOT place things into proper perspective. I really don't expect much from reps but I do expect a small modicum of decency about this especially when you and I both know that little old Bonnie will just read your shameful post and repeat it on to her bridge club members and a bad spiral ensues. As long as you dumb reps put up hideous posts, I will knock 'em down like Babe Ruth. Capiche?
Click to expand...

its like the Shining with the blood flowing down the hallways and walls of the Overlook
 




Anonymous said:
It's amazing how you really think I am "sad and callous". I get it on the level of people, having a stroke, ich, death is a pretty shitty event. But maybe you could re-read the post slowly and let it sink in that their is a reason that ADR's for dabi will be at a level quite higher than expected: that is because reps are out there actively doing their job and reporting any "weird" or "maybe weird" phenomonon on to BI because they care enough to report every little or big thing about the drug. this is the way Bi trains its reps and should be commended. The fact that this drug would have such high ADRs should be tempered by the fact that NO OTHER COMPANY IS DOING THIS!!! Do you get it now? or should I spend some more time explaining quite clearly that we docs do NOT call in adverse drug events when we have a little ol' lady come in my office with hematuria due to warfarin. I just bump dose and move on. Dabi is an anticoagulant and if NOT USED CORRECTLY you will get some bad results. Hell, even when it IS USED CORRECTLY you should expect to find bad results. It's the nature of the game. I merely think it's shameful someone would start this post with a tagline about "bleeds keep coming" and NOT place things into proper perspective. I really don't expect much from reps but I do expect a small modicum of decency about this especially when you and I both know that little old Bonnie will just read your shameful post and repeat it on to her bridge club members and a bad spiral ensues. As long as you dumb reps put up hideous posts, I will knock 'em down like Babe Ruth. Capiche?
Click to expand...

"we docs"? You're a delusional douchebag BI rep, certainly not a doctor.
 




Anonymous said:
It's amazing, and incredibly sad, how callous you are towards a serious adverse event that could have significant negative impact, including death, on a patient and their family. I'm sorry your bonus check and enormous ego have created as much narcissistic tunnel vision as they have, you really are a pathetic boob and your ignorance of the reality of anticoagulant treatment makes everyone who promotes meds look stupid.
Click to expand...

It's not surprising. People at BI have their heads so far up their asses, this kind of thinking is normal there.
 












Anonymous said:
how many adverse requests are being submited by BI reps. Hear is a good check list....http://www.fda.gov/Drugs/DrugSafety/ucm282724.htm
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That's awesome bi is submitting these!! I only wish the warfarin reps would do the same! Oh wait there aren't any, well what do you know. Hope that doesn't skew the bleed rate statistics. Nah, surely docs are calling the FDA every time they see bruising on a patient taking warfarin. Yeah, that's right I am sure they are doing this. Next.
 








Anonymous said:
It's amazing how you really think I am "sad and callous". I get it on the level of people, having a stroke, ich, death is a pretty shitty event. But maybe you could re-read the post slowly and let it sink in that their is a reason that ADR's for dabi will be at a level quite higher than expected: that is because reps are out there actively doing their job and reporting any "weird" or "maybe weird" phenomonon on to BI because they care enough to report every little or big thing about the drug. this is the way Bi trains its reps and should be commended. The fact that this drug would have such high ADRs should be tempered by the fact that NO OTHER COMPANY IS DOING THIS!!! Do you get it now? or should I spend some more time explaining quite clearly that we docs do NOT call in adverse drug events when we have a little ol' lady come in my office with hematuria due to warfarin. I just bump dose and move on. Dabi is an anticoagulant and if NOT USED CORRECTLY you will get some bad results. Hell, even when it IS USED CORRECTLY you should expect to find bad results. It's the nature of the game. I merely think it's shameful someone would start this post with a tagline about "bleeds keep coming" and NOT place things into proper perspective. I really don't expect much from reps but I do expect a small modicum of decency about this especially when you and I both know that little old Bonnie will just read your shameful post and repeat it on to her bridge club members and a bad spiral ensues. As long as you dumb reps put up hideous posts, I will knock 'em down like Babe Ruth. Capiche?
Click to expand...

If you were my doctor, I'd fire your ass and get someone who knew what they were doing and most importantly acted a little more professional. Your first obligation in treating any patient is "first do no harm." It seems you have already forgotten the oath you took.
 




Anonymous said:
If you were my doctor, I'd fire your ass and get someone who knew what they were doing and most importantly acted a little more professional. Your first obligation in treating any patient is "first do no harm." It seems you have already forgotten the oath you took.
Click to expand...

Thanks for sharing your opinion, but I didn't ask you for it.
 




Lets just ask some basic questions that hopefully a "educated" rep would know:
Heparin- whats the antidote?
A: Protamine Sulfate

Coumadin (Warfarin Sodium)- whats the antidote?
A: Vitamin K

Pradaxa- whats the antidote?
A: There is NONE!

You see, thats the difference, when something goes wrong the other two can be corrected......

Oh, dont forget PRADAXA has a 4 month expiration date due to humidity.....
 








Anonymous said:
Lets just ask some basic questions that hopefully a "educated" rep would know:
Heparin- whats the antidote?
A: Protamine Sulfate

Coumadin (Warfarin Sodium)- whats the antidote?
A: Vitamin K

Pradaxa- whats the antidote?
A: There is NONE!

You see, thats the difference, when something goes wrong the other two can be corrected......

Oh, dont forget PRADAXA has a 4 month expiration date due to humidity.....
Click to expand...
If you don't mind me asking, how long does it take for vit k to reverse out warfarin? Any educated reps out there?
 




Anonymous said:
..........
Oh, dont forget PRADAXA has a 4 month expiration date due to humidity
.........
Click to expand...

So what's the problem, I person needs to take the 60 caps in their bottle in 30 days but now they ave 3 more months to finish that one bottle. How is this a problem, you lost me there. This would seem to be a good thing. Also, if you have a problem consuming 60 caps in a 4 month period you can have the pharmacy order the drug in the easy-tare unit dose which makes it good for 60 caps to be consumed in 1 year. Happy now?
 




Anonymous said:
If you don't mind me asking, how long does it take for vit k to reverse out warfarin? Any educated reps out there?
Click to expand...

While you are at it. Post vitamin k push, how long befor a patient can resume their Coumadin? Any "educated" guesses?

Hint: pdax makes you sufficiently anticoagulated 2 hrs after you take it. So, lapse in treatment then back in the game w/o enoxaparin after 2 hrs- this is a bad thing?
 




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