Education Blog for Healthcare Professionals

NO FDA Approval Yet for Andexanet

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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.



  1. Portola announcement from Aug 18, 2016:
  2. 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

Heavier Menstrual Bleeding on Xarelto?

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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].

Read the rest of this entry »

Contraceptive Use While on Anticoagulants is Safe

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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 »

Bleeding on Antithrombotics: Reversal Protocol 2016

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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

IVC Filters, May-Thurner Syndrome, Pelvic Vein Stents

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Stephan Moll, MD writes… An article for patients discussing (a) IVC filters, (b) narrowing of the main left pelvic vein (May-Thurner syndrome) and (c) pelvic venous stents has just been published (  Color images of anatomy, filters and stents are included as visual aids.  The article may be helpful as handout material for patients in clinic.

Reference:  Carroll S, Moll S. Circulation. 2016;133:e383-e387


Last updated: Feb 18th, 2016

MTHFR and Homocysteine: Information Handout for Patients

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Stephan Moll, MD writes… A plain language summary for patients and interested public about homocysteine and the MTHFR mutations and their relevance in respect to thrombosis was  published today in the journal Circulation (link here).

Reference:  Moll S, Varga EA.  Homocysteine and MTHFR Mutations. Circulation. 2015;132:e6-e.