Xarelto is approved but has a boxed warning

[Anonymous]

http://www.pharmalot.com/2011/11/fda-oks-xarelto-but-adds-a-black-box-warning/

 

[Anonymous]

No worries - actually a strength in a way! We are in solid shape and should kick some butt!

 

[Anonymous]

PLEASE.....boxed warning to consult your doc if you stop taking the drug. Duh....

You forgot to mention it has qd dosing while all other anticoags don't. Seems like better compliance will win the day.

 

[Anonymous]

Do you guys even listen to the stuff you say. Are you honestly going to spin to a Physician that a black box warning is a good thing when dabigatran does not. Can I get some of the whackey weed you're on too.

 

[Anonymous]

PLEASE.....boxed warning to consult your doc if you stop taking the drug. Duh....

Xarelto Product Package Insert
_____________________
A. Discontinuing xarelto in patients with nonvalvular atrial
fibrillation

Discontinuing XARELTO places patients at an increased risk of thrombotic
events. An increased rate of stroke was observed following XARELTO
discontinuation in clinical trials in atrial fibrillation patients. If anticoagulation
with XARELTO must be discontinued for a reason other than
pathological bleeding, consider administering another anticoagulant [see
Dosage and Administration (2.1), Warnings and Precautions (5.1), and
Clinical Studies (14.1)].
_______________________________


It's a little more in depth than "duh", Sparky. If you need to stop for a tooth extraction, biopsy, colonoscopy, etc, the physician will have to bridge you to another anticoagulant and then taper them off that one before a procedure can continue. What a pain in the ass.

Glad to see the fine folks of Bayer minimizing their ethical obligations. Is this a corporate policy?

 

[Anonymous]

PLEASE.....boxed warning to consult your doc if you stop taking the drug. Duh....

You forgot to mention it has qd dosing while all other anticoags don't. Seems like better compliance will win the day.

There is no significant improvement in compliance with QD versus BID. In fact a lot of physicians like BID the reason being that if the patient forgets at least there is a 50/50 chance of them taking the 2nd dose. With QD if one is missed...

The problem we’re going to have is no data with the patient group that makes up the bulk of AFib patients – good luck in the GPs office finding CHADS3 patients

 

[Anonymous]

Surprised that most of you BI reps could get past the no spam verification question. The fat lady is about to sing.....love, Sparky.

 

[Anonymous]

Xarelto Product Package Insert
_____________________
A. Discontinuing xarelto in patients with nonvalvular atrial
fibrillation

Discontinuing XARELTO places patients at an increased risk of thrombotic
events. An increased rate of stroke was observed following XARELTO
discontinuation in clinical trials in atrial fibrillation patients. If anticoagulation
with XARELTO must be discontinued for a reason other than
pathological bleeding, consider administering another anticoagulant [see
Dosage and Administration (2.1), Warnings and Precautions (5.1), and
Clinical Studies (14.1)].
_______________________________


It's a little more in depth than "duh", Sparky. If you need to stop for a tooth extraction, biopsy, colonoscopy, etc, the physician will have to bridge you to another anticoagulant and then taper them off that one before a procedure can continue. What a pain in the ass.

Glad to see the fine folks of Bayer minimizing their ethical obligations. Is this a corporate policy?

Whoa, no way, this is terrible and they didn't tell us this in our launch meetings

 

[Anonymous]

Whoa, no way, this is terrible and they didn't tell us this in our launch meetings

Hey sunshine, has the BI Med Group told you about required liver function tests with your product ?

 

[Anonymous]

Xarelto Product Package Insert
_____________________
A. Discontinuing xarelto in patients with nonvalvular atrial
fibrillation

Discontinuing XARELTO places patients at an increased risk of thrombotic
events. An increased rate of stroke was observed following XARELTO
discontinuation in clinical trials in atrial fibrillation patients. If anticoagulation
with XARELTO must be discontinued for a reason other than
pathological bleeding, consider administering another anticoagulant [see
Dosage and Administration (2.1), Warnings and Precautions (5.1), and
Clinical Studies (14.1)].
_______________________________


It's a little more in depth than "duh", Sparky. If you need to stop for a tooth extraction, biopsy, colonoscopy, etc, the physician will have to bridge you to another anticoagulant and then taper them off that one before a procedure can continue. What a pain in the ass.

Glad to see the fine folks of Bayer minimizing their ethical obligations. Is this a corporate policy?

You're a fucking idiot. Pradaxa has to be stopped as well. You don't bridge in this case, moron. Take your University of Phoenix piece of paper "degree" and go wipe the shit out of your mouth.

 

[Anonymous]

You're a fucking idiot. Pradaxa has to be stopped as well. You don't bridge in this case, moron. Take your University of Phoenix piece of paper "degree" and go wipe the shit out of your mouth.

The zarelto PI clearly states to "bridge to another anticoagulant..." there is NO WAY to misread this. I have a 6 year degree in Racquetball and I am still able to process that a doc will have to bridge a patient with lovenox just so they can do a biopsy, tooth, extraction, colonoscopy.

Here it is again for you to read. It's pretty clear that you can just "stop" taking zarelto w/o going to lovenox.

___________________

Discontinuing XARELTO in the absence of adequate alternative anticoagulation
increases the risk of thrombotic events. An increased rate of stroke was
observed during the transition from XARELTO to warfarin in clinical trials in atrial
fibrillation patients. If XARELTO must be discontinued for a reason other than
pathological bleeding, consider administering another anticoagulant [see
Dosage and Administration (2.1) and Clinical Studies (14.1)].

____________________

Is it your Corporate policy to make light of this or are "you" just minimizing the risks? Please state clearly how this was covered in your launch meeting

 

[Anonymous]

The zarelto PI clearly states to "bridge to another anticoagulant..." there is NO WAY to misread this. I have a 6 year degree in Racquetball and I am still able to process that a doc will have to bridge a patient with lovenox just so they can do a biopsy, tooth, extraction, colonoscopy.

Here it is again for you to read. It's pretty clear that you can just "stop" taking zarelto w/o going to lovenox.

___________________

Discontinuing XARELTO in the absence of adequate alternative anticoagulation
increases the risk of thrombotic events. An increased rate of stroke was
observed during the transition from XARELTO to warfarin in clinical trials in atrial
fibrillation patients. If XARELTO must be discontinued for a reason other than
pathological bleeding, consider administering another anticoagulant [see
Dosage and Administration (2.1) and Clinical Studies (14.1)].

____________________

Is it your Corporate policy to make light of this or are "you" just minimizing the risks? Please state clearly how this was covered in your launch meeting

Wouldn't know... I'm not a rep and I don't work for Bayer. By training, I'm a clinician which is better than you- a piece of gum stuck on the bottom of a shoe.

 

[Anonymous]

Wouldn't know... I'm not a rep and I don't work for Bayer. By training, I'm a clinician which is better than you- a piece of gum stuck on the bottom of a shoe.

Oh please, if you weren't a rep you wouldn't even be on here. What the hell's a clinician doing on here anyway; you should be back at the make-up counter in Macy's pushing your overpriced make-up rather than trolling an anonymous chat-board. Loser.