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Archive for the ‘Anticoagulants’ Category

NO FDA Approval Yet for Andexanet

| Anticoagulants, Bleeding, Therapy, Uncategorized | Comments Off on NO FDA Approval Yet for Andexanet

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.

 

References

  1. Portola announcement from Aug 18, 2016: http://bit.ly/2c1wKaK
  2. Connolly SJ et al. Andexanet alfa for acute major bleeding associated with factor Xa inhibitors. NEJM 2016;Aug 30 [e-pub]
     (http://dx.doi.org/10.1056/NEJMoa1607887)

 

Disclosure:  I have consulted for Portola, Janssen, and Boehringer-Ingelheim.

Last updated: Aug 31st, 2016

Contraceptive Use While on Anticoagulants is Safe

| Anticoagulants, Bleeding, Uncategorized, Women and blood clots | Comments Off on Contraceptive Use While on Anticoagulants is Safe

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

| Bleeding, Guideline, Uncategorized | Comments Off on Bleeding on Antithrombotics: Reversal Protocol 2016

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

New Comprehensive Clinical Guidance on VTE Treatment

| Anticoagulants, Guideline, Therapy, Thrombophilias, Uncategorized | Comments Off on New Comprehensive Clinical Guidance on VTE Treatment

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 »

ACCP Guideline for DVT and PE Treatment: New Edition, 2016

| Anticoagulants, Aspirin, Plavix, Aggrenox, Tiklid, Persantine, Edoxaban, Eliquis, Guideline, Pradaxa (dabigatran), Therapy, Uncategorized, Xarelto (Rivaroxaban) | Comments Off on ACCP Guideline for DVT and PE Treatment: New Edition, 2016

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 in Jan 2016 [ref 1]. Unfortunately, the guideline is not available for non-subscribers. Read the rest of this entry »

Fourth NOAC FDA Approved for DVT, PE and Atrial Fibrillation: Savaysa (Edoxaban)

| Edoxaban, Eliquis, Pradaxa (dabigatran), Uncategorized, Xarelto (Rivaroxaban) | Comments Off on Fourth NOAC FDA Approved for DVT, PE and Atrial Fibrillation: Savaysa (Edoxaban)

Stephan Moll, MD writes…. Today (Jan 8th, 2015) the FDA approved yet another new oral anticoagulant, Savaysa (edoxaban), for the treatment of DVT and PE, as well as for atrial fibrillation. The FDA press release  is here (link).  Savaysa is the 4th of the NOACS now approved for VTE treatment. This table summarizes the differences, advantages and disadvantages comparing the 4 drugs. The detailed drug package insert with dosing information is here (link). Read the rest of this entry »