Posts Tagged ‘bleeding’
Stephan Moll, MD writes… The FDA did NOT approve Andexanet (brand names: AndexXa™ in the US, IndexXa™ in Europe) in a decision on August 18th, 2016. Andexanet is the antidote in clinical development to reverse the anticoagulant effect of Eliquis® (rivaroxaban), Savaysa® (edoxaban), Xarelto® (rivaroxaban) and Lovenox® (enoxaparin). The FDA is said to have requested more information from the company (Portola) making Andexanet, specifically (a) additional information related to manufacturing of the drug, and (b) more data to support inclusion of Savaysa® and Lovenox® in the label. The FDA also wants to finalize its review of the company’s proposals for post-marketing data collection on the performance of the drug.
It needs to be seen when the company (Portola) submits the requested additional information to the FDA and when a new decision from the FDA is then to be expected. My guess is that this will be sometime in 2017.
- Portola announcement from Aug 18, 2016: http://bit.ly/2c1wKaK
- Connolly SJ et al. Andexanet alfa for acute major bleeding associated with factor Xa inhibitors. NEJM 2016;Aug 30 [e-pub]
Disclosure: I have consulted for Portola, Janssen, and Boehringer-Ingelheim.
Last updated: Aug 31st, 2016
Stephan Moll, MD writes… Interesting and noteworthy observations published in the last 2 weeks: Heavy menstrual bleeding appears to occur more commonly with Xarelto® than with warfarin [ref 1] and may be also more common with Xarelto® than with Eliquis® [ref 2].
Stephan Moll, MD writes… Interesting and clinically relevant publication this week [ref 1]. It is well known that estrogens and certain progestin preparations increase the risk for venous thromboembolism (VTE). A woman on an anticoagulant may have heavy menstrual bleeds and hormonal therapy – such as estrogen-progestin contraceptives – may be considered to decrease the bleeding.
The newly published study Read the rest of this entry »
Stephan Moll, MD writes… Our medical center (University of North Carolina Hospitals, Chapel Hill) has put together a comprehensive “Emergent Anticoagulation Reversal Guideline” for our local use, updated since its last edition in 2014 with information about Pradaxa® reversal (with Praxbind®). It is a practical, clinical how-to document (2016 PDF here ). Colleagues and hospitals are welcome to take the document, modify it, and apply it to their institution – there are no copyright concerns.
Disclosures: I have been a consultant on one occasion for Boehringer-Ingelheim.
Last updated: May 11th, 2016
Stephan Moll, MD writes… A publication in the New England Journal of Medicine today reports on the use of the Pradaxa® (Dabigatran) antidote Idarucizumab in patients on Pradaxa® who present with major bleeding or require urgent surgery [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
A patient may ask: “I am on warfarin. Is it o.k. for me to drink alcohol? Does alcohol intake increase the INR?”
Does drinking alcohol change the INR in the patient on warfarin? Read the rest of this entry »
When a patient on warfarin bleeds more than usual it is, of course, important to make sure that the INR is not supra-therapeutic. And, if the INR is too high, warfarin therapy needs to be adjusted and other treatment (vitamin K, etc) may have to be employed depending on the degree of INR elevation and bleeding. However, in case of minor bleeds on anticoagulants, such as skin cuts or nosebleeds, several over-the-counter products are available and may be helpful for the patient. Read the rest of this entry »
What is HHT?
HHT (Hereditary Hemorrhagic Teleangiectasia), called Osler-Weber-Rendu syndrome, is an inherited disorder in which small blood vessels develop abnormally [ref 1]. It is estimated that 30,000 to 60,000 people (1 out 5,000 to 10,000) in the United States are affected. Individuals with HHT develop telengiectasias in the skin (usually in the fingers and hands) and the mucosa of the nose and mouth. Similar abnormal blood vessels (arterial-venous malformations, AVMs) can also develop in internal organs Read the rest of this entry »
Major and life-threatening bleeding is expected to occur in some patients treated with Pradaxa® (=Dabigatran). The question will then urgently arise how to best treat such catastrophic bleeding. Read the rest of this entry »