Patient Education Blog

Archive for the ‘Bleeding’ Category

NO FDA Approval Yet for Antidote for Xarelto, Eliquis and Savaysa

| Bleeding, Blood thinners (anticoagulants), Therapy | Comments Off on NO FDA Approval Yet for Antidote for Xarelto, Eliquis and Savaysa

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 drug in clinical trials as an antidote to reverse the blood thinning effect of Eliquis®, Savaysa®, Xarelto® 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 (enoxaparin)  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 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 Blood Thinners is Safe

| Bleeding, Blood thinners (anticoagulants), Uncategorized, Women and blood clots | Comments Off on Contraceptive Use While on Blood Thinners is Safe

Stephan Moll, MD writes… Interesting and relevant publication this week [reference 1].  It is well known that estrogen–containing birth control methods (pills, vaginal rings, patches, injectables) increase the risk for DVT and PE.  As women on blood thinners may have heavy menstrual bleeds, hormonal therapy may be considered to decrease the bleeding.  Also, women on blood thinners may want to choose a method for contraception other than a progestin IUD (Mirena® IUD, Skyla® IUD).

The newly published study Read the rest of this entry »

Antidote for Pradaxa (Dabigatran): FDA Approval By End of 2015?

| Andexanet, Bleeding, Blood thinners (anticoagulants), Idarucizumab, Therapy | Comments Off on Antidote for Pradaxa (Dabigatran): FDA Approval By End of 2015?

Stephan Moll, MD writes:  A drug in development (Idarucizumab) that reverses the blood thinner Pradaxa® (Dabigatran) is on a very promising path to get FDA approval in the next few months and be available for clinical use by the end of 2015.
Read the rest of this entry »

Major Bleeding on the New Oral Blood Thinners: Update on Reversal Drugs

| Bleeding, Blood thinners (anticoagulants), Eliquis - Apixaban, Pradaxa - dabigatran, Savaysa - Edoxaban, Therapy, Xarelto - Rivaroxaban | Comments Off on Major Bleeding on the New Oral Blood Thinners: Update on Reversal Drugs

Stephan Moll, MD writes (on Nov 7th, 2014)… A publication this week in the New England Journal of Medicine reports on a new reversal agent (PER977 = Aripazine = ciraparantag) that may be effective against a number of different new oral anticoagulants [ref 1]. Read the rest of this entry »

Major Bleeding on Blood Thinners: Practical Guideline

| Bleeding, Blood thinners (anticoagulants) | Comments Off on Major Bleeding on Blood Thinners: Practical Guideline

Stephan Moll, MD writes…  Major bleeds on blood thinners (such as Coumadin, Jantoven, Eliquis, Pradaxa, Xarelto) and anti-platelet drugs (like aspirin, Plavix, Brilinta, Effient, etc.) occur every so often.  Quick action in Emergency Departments is needed in case of such bleeds.  Our medical center (University of North Carolina Hospitals,  Chapel Hill) has put together an “Emergent Anticoagulation Reversal Guideline” for our local use as a practical, clinical how-to document (PDF here).  Since not every medical institution has pharmacists and MDs with clotting expertise available to develop its own guideline, we are making this document available through Clot Connect and invite colleagues and hospitals  to take the document if they like, modify it, and apply it to their institution.

 

Disclosures:  I have been a consultant for CSL Behring and Janssen.

Last updated: June 9th, 2014

New Publication: Increased Bleeding Risk When Taking Blood Thinners Together with Aspirin and Certain Pain Medications (NSAIDs)

| Bleeding, Blood thinners (anticoagulants) | Comments Off on New Publication: Increased Bleeding Risk When Taking Blood Thinners Together with Aspirin and Certain Pain Medications (NSAIDs)

Bruce L Davidson, MD, writes… Our study published in JAMA Internal Medicine [reference below] used patient information (with no identifying information, so confidentiality was preserved) from the two EINSTEIN clinical studies of acute DVT and acute PE treatment to ask the questions, “What effect does taking aspirin, or non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin, have on bleeding risk if the patient is also taking a blood thinner (anticoagulant)?” Read the rest of this entry »

Major Bleeding on Pradaxa (Dabigatran) – Interesting Publication

| Bleeding, Blood thinners (anticoagulants), Pradaxa - dabigatran, Therapy | Comments Off on Major Bleeding on Pradaxa (Dabigatran) – Interesting Publication

Stephan Moll, MD writes…

Interesting publication this week in Circulation: “Management and outcomes of major bleeding during treatment with dabigatran or warfarin” (Majeed A et al; published online Sept 30,2013; full publication is here). The management and prognosis of major bleeding in patients treated with dabigatran or warfarin was compared, pooling data of the major bleeds that occurred in 5 phase III dabigatran trials. 1,121 major bleeds occurred in 27,419 patients treated with warfarin or dabigatran. Read the rest of this entry »

Red Eye – Subconjunctival Bleed on Blood Thinners

| Bleeding, Blood thinners (anticoagulants), warfarin / coumadin | Comments Off on Red Eye – Subconjunctival Bleed on Blood Thinners

Stephan Moll, MD, writes… A subconjunctival bleed (hemorrhage) is a bleed underneath the transparent conjunctiva , and in front of the white (sclera) of the eye ball (see image). The conjunctiva contains many small and fragile blood vessels that easily rupture or break. This leads to blood leaking into the space between the conjunctiva and sclera. Read the rest of this entry »