Archive for the ‘Blood thinners (anticoagulants)’ Category
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
- 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]
(http://dx.doi.org/10.1056/NEJMoa1607887)
Disclosure: I have consulted for Portola, Janssen, and Boehringer-Ingelheim.
Last updated: Aug 31st, 2016
Increased Menstrual Bleeds on Xarelto?
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 »
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 »
Scuba Diving: Can I Dive While Being on a Blood Thinner?
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 »
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 »
Another Oral Blood Thinner FDA-Approved for DVT and PE – Savaysa
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 »
Two Things Physicians Should Avoid
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 »
Fascinating New Drug that Prevents Blood Clots Without Increasing Bleeding Risk
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 »
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 »
Aspirin Can Prevent Recurrent DVT and PE
Stephan Moll, MD writes… For patients stopping blood thinning therapy (anticoagulation) whose deep vein thrombosis (DVT) or pulmonary embolism (PE) was considered unprovoked (i.e. out of the blue and with no obvious triggering, transient cause, such as surgery, hormone use, immobility), aspirin is beneficial in some patients in preventing further clots. A new publication in the journal Circulation re-confirms findings from two previous studies, showing that aspirin reduces the risk of recurrent DVT/PE by more than a third without significantly increasing the risk of bleeding [ref 1,2,3]. Read the rest of this entry »