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.
- 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 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 »
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 »
Stephan Moll, MD writes… An article for patients discussing (a) IVC filters (inferior vena cava filters; also often referred to as “Greenfield filters”), (b) narrowing of the main left pelvic vein (referred to as May-Thurner syndrome) and (c) stents in veins in the pelvis has just been published (http://circ.ahajournals.org/content/133/6/e383.full.pdf). Color images are included helping explain what these conditions are.
Reference: Carroll S, Moll S. Circulation. 2016;133:e383-e387
Last updated: Feb 18th, 2016
Stephan Moll, MD writes… A research study is being conducted at the University of Minnesota by Dr. Pamela Lutsey. The goal of the study is to learn more about patients’ concerns and preferences regarding blood thinner use for the treatment of DVT and PE. The results will help investigators better create future clinical studies to improve treatment of DVT and PE. This is NOT a pharmaceutical industry or marketing survey. If you are a patient who has had a DVT or PE it would be great if you were willing to take the short survey. It will take about 10 minutes to complete. Thank you very much. The following link will direct you to the secure survey site: z.umn.edu/vtesurvey.
Last updated: Jan 28,2016
Stephan Moll, MD writes… A new consensus guidance for health care professionals on management of DVT and PE - link here - was published today, Jan 18th, 2016, in the Journal of Thrombosis and Thrombolysis. The publication contains 13 chapters on various aspects of DVT and PE (acute treatment, decisions on length of blood thinner treatment, thrombophilia work-up, management at times of surgery, etc.). It incorporates both evidence-based data and consensus opinion of the 52 international experts who wrote these chapters. It is aimed at any type of health care professional who is involved in the management of DVT and PE – emergency room physicians, hospitalists, internists, cardiologists, hematologists, pharmacists and others.
Last updated: Jan 18th, 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 blood thinners for various indications, including DVT and PE. The 10th edition of the chapter on DVT and PE management was published today – link here.
This 38 page document focusses on the best management of DVT and PE. It provides 30 individual recommendations (page 7-19) and a discussion of the evidence behind the guidance. It uses the terms “suggest” and “recommend” for its guidance, depending on the strength of published evidence.
- Choice of blood thinner:
In patients with DVT of the leg or PE (and no cancer) the suggestion is to use one of the newer oral blood thinners (Eliquis, Pradaxa, Savaysa or Xarelto) rather than warfarin (Coumadin, Jantoven) therapy!
- Cancer patients with DVT or PE:
In cancer patients with DVT of the leg or PE an injectable blood thinner called “low molecular weight heparin” (Lovenox = enoxaparin; Fragmin = dalteparin; Innohep = tinzaparin) is suggested rather than an oral drug.
- How long to treat with blood thinners?
- DVT (in veins in the pelvis, thigh or behind the knee, termed “proximal DVT) or PE provoked by surgery: recommend 3 months of blood thinners.
- Proximal DVT or PE provoked by non-surgical transient risk factor (e.g. estrogens, pregnancy, leg injury, flight > 8 hrs): suggest 3 months of blood thinners.
- Unprovoked proximal DVT or PE: suggest long-term blood thinners.
- Distal DVT, i.e. below the knee
- if not severely symptomatic : suggest no blood thinners, but follow-up Doppler ultrasound imaging study
- if severely symptomatic: suggest 3 months of blood thinners.
- Role of aspirin:
In patients with unprovoked proximal DVT or PE who stop blood thinners, aspirin is suggested.
This is a solid guideline and good publication.
Conflict of interest: None
Last updated: Jan 8th, 2016
Stephan Moll, MD writes… In general: “Yes”. Many people who take blood thinners are able to safely dive. However, there are a few things to consider for the individual on blood thinners who wants to go scuba diving: 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 blood clots 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… The American Society of Hematology (ASH) is embarking on a program to develop clinically useful guidelines on the best management of patients with deep vein thrombosis or pulmonary embolism. ASH appropriately desires input from patients for the development of these guidelines. Any interested patient please see this letter from ASH explaining the goals of the project and what is needed.
Last updated: July 1st, 2015