Archive for the ‘Warfarin (Coumadin)’ Category
Stephan Moll, MD writes… Apixaban (Eliquis®) was approved by the FDA this week (Aug 21, 2014) for the treatment of DVT and PE. The approval covers (a) acute DVT/PE management and (b) prevention of recurrent DVT/PE. Read the rest of this entry »
Stephan Moll, MD writes… LMWH (low molecular weight heparin) is the preferred anticoagulant in the pregnant patient. LMWH and warfarin are safe in the woman who is beast-feeding.
Rivaroxaban (Xarelto), dabigatran (Pradaxa) and apixaban (Eliquis) should not be used during pregnancy or while breastfeeding.
Stephan Moll, MD writes… Patients who are on warfarin for a history of DVT or PE may inquire whether a switch to one of the new oral anticoagulants is appropriate. Similarly, many physicians initiate this discussion with their patients.
This is, obviously, a detailed discussion and an individualized decision with a number of factors to be considered. We have developed a two-page “Comparison of Oral Blood Thinners” handout for patients, to assist with and summarize the discussion. This sheet allows a structured discussion with the patient about the pros and cons of the various anticoagulant choices. The reader is welcome to print this resource and use it as a handout for his/her patients.
Disclosure: I have been a consultant for Boehringer-Ingelheim, Daiichi, and Janssen.
Last Updated: Dec 19th, 2013
Stephan Moll, MD writes… The FDA approved today (Dec 13th, 2013) the use of the drug Kcentra® for urgent warfarin reversal in patients who need an urgent surgical procedure. This extends the indications for use of this drug – it had been approved by the FDA in April 2013 to treat major bleeding on warfarin [ref 1]. Read the rest of this entry »
Stephan Moll, MD writes… A new drug for the urgent reversal of warfarin was approved by the FDA today, April 29th, 2013 (announcement by the FDA is here), called Kcentra. The drug is derived from pooled plasma from healthy blood donors and contains the coagulation factors that are low in warfarin-treated patients, i.e. factors II, VII, IX, and X. It is also referred to as a 4-factor concentrate, or non-activated Prothrombin Complex Concentrate (PCC). The drug prescribing information (package insert) is here.
Up until now only 3-factor concentrates (PCC) and fresh frozen plasma (FFP) were available in the U.S. in addition to vitamin K to urgently reverse warfarin and to treat major bleeding in warfarin-treated patients. The new drug is a welcome addition to the armamentarium when having to treat warfarin-associated major bleeding. Where until now I used to give 3-factor PCCs, I will now give the 4-factor PCC.
Bleeding and the new oral anticoagulants
A question that will now be raised is whether this new drug is also suitable to treat major bleeding on one of the new oral anticoagulants, i.e. Xarelto, Pradaxa, or Eliquis. It is not known whether Kcentra would be beneficial in that situation. However, as some hospitals and clinicians presently have 3-factor PCCs on their reversal algorithm, it is fair to consider a review and possible modification of the hospital treatment guidelines on the management of major bleeding not only on warfarin, but also on the new oral anticoagulants.
Sarode R et al. Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding. A randomized, plasma-controlled, phase IIIb study. Circulation 2013;128:1234-1243.
Disclosure: I have consulted for CSL Behring, the comapny making Kcentra.
Last updated: Dec 13th, 2013
Stephan Moll, MD writes…
Occasionally, recurrent DVT or PE occur in spite of warfarin therapy, particularly in patients with (a) fluctuating and sub-therapeutic INRs, (b) lupus anticoagulant/ antiphospholipid antibody (APLA) syndrome or (c) cancer. Read the rest of this entry »
Stephan Moll writes…
2012 has been a year with significant progress in the field of venous thromboembolism and anticoagulation. The three most noteworthy, clinically relevant developments were probably (a) the publication of the new ACCP (American College of Chest Physician) guidelines on antithrombotic therapy in February 2012; (b) The FDA-approval of rivaroxaban (Xarelto) in November 2012 for the acute treatment of venous thromboembolism (VTE) and long-term secondary prevention; and (c) The FDA-approval of apixaban (Eliquis) in December 2012 for atrial fibrillation and the prevention of arterial thromboembolism. Here I have listed and summarized the 10 top publications of 2012 in the field of venous thromboembolism and anticoaguation as I see them – the ones clinically most relevant.
Disclosure: I have consulted for Janssen, Boehringer-Ingelheim and Daiichi.
Last updated: Feb 7th, 2013
Stephan Moll, MD writes… Well, it is not clear whether it does. A clinically relevant study (ASPIRE study) was published this week (Nov 22nd,2012) in the N Engl J Med [ref 1]. In patients who had a previous unprovoked (= idiopathic) DVT or PE and who had completed standard length (often considered to be 3-6 months) of warfarin therapy, aspirin did not prevent recurrent VTE. However aspirin was effective in preventing further thrombotic event (a conglomerate of arterial and venous events). Aspirin did not lead to an increase in risk of major bleeding. The findings are discrepant to the earlier WARFASA study, published in May 2012 in the N Engl J Med, which showed that Aspirin had efficacy in preventing recurrent VTE [ref 2]. The ASPIRE authors have also included a revealing, meta-analysis of this week’s study plus the previous WARFASA study [ref 2].
Stephan Moll, MD writes…
A detailed, practical discussion on INR self-testing for patients is available here, addressing:
- Reasons to do INR self-testing
- Which patients are suitable
- What INR home monitoring devices are available
- Whether the devices give reliable INR results
- Whether insurance companies pay for them Read the rest of this entry »
Stephan Moll, MD writes…
Traditionally, INR testing in patients on warfarin has been recommended by anticoagulation providers in the U.S. to be done at least once every 4 weeks. However, a recent study showed that testing every 3 months is sufficient Read the rest of this entry »