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… 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 (http://circ.ahajournals.org/content/133/6/e383.full.pdf). 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
Stephan Moll, MD writes… A new consensus guidance on management of venous thromboembolism (VTE) - link here – was published today, Jan 18th, 2016, in the Journal of Thrombosis and Thrombolysis. The publication contains 13 chapters on various aspects of VTE Read the rest of this entry »
The ACCP Chest Guidelines have been the main guide over the last more than 2 decades for evidence-based recommendations on best management of anticoagulants for various indications, including DVT and PE. The 10th edition of the chapter on DVT and PE management was published today (link to the guideline here). Read the rest of this entry »
Stephan Moll, MD writes… Can patients on anticoagulants safely scuba dive? In general: “Yes”. Many people who take anticoagulants are able to safely dive. However, there are a few things to consider: Read the rest of this entry »
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.
Stephan Moll, MD writes: Interesting and relevant publication today in the New England Journal of Medicine (NEJM) Read the rest of this entry »