Archive for the ‘Therapy’ Category
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 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
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 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 »
Stephan Moll, MD writes…. Today (Jan 8th, 2015) the FDA approved yet another new oral blood thinner, Savaysa (edoxaban), for the treatment of DVT and PE. The drug was also FDA approved today for stroke prevention in patients with irregular heart beat (atrial fibrillation). The FDA press release here (link). Read the rest of this entry »
Stephan Moll, MD writes (Dec 17, 2014)… The American Society of Hematology (ASH) published last week two things that physicians dealing with DVT, PE and blood thinners should avoid [ref 1]. Read the rest of this entry »
Stephan Moll, MD writes (on Dec 8th, 2014)… A publication this week in the New England Journal of Medicine reports on a drug in development that protects patients from blood clots (DVT), without increasing the risk of bleeding. Too good to be true? Possibly, but may be not. Additional studies will have to tell. Read the rest of this entry »