7 January 2021Information on use of the vaccine in patients who are receiving anticoagulants or have a bleeding disorder is given below.
Consultations (counselling) about oral anticoagulants apixaban, dabigatran, edoxaban, rivaroxaban and warfarin for patients with aphasia
8 October 2020These resources are designed to support all clinicians who communicate with patients prescribed warfarin or direct oral anticoagulants (DOACs), formerly known as novel oral anticoagulants…
18 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Oral anticoagulants The coumarin anticoagulants, warfarin…
26 May 2020Anticoagulation is key to reducing the risk of stroke in atrial fibrillation (AF). However ensuring that the anticoagulant is prescribed at the correct dose for…
Non-vitamin K antagonist oral anticoagulants (NOACs): Is it safe to take them with herbal medicines?
26 March 2020There is a lack of scientific evidence of the safety and efficacy of herbal medicines together with an under-reporting and underestimation of adverse effects. Interactions…
Medicine Compliance Aid Stability
Capsules 75mg, 110mg, 150mg
R2 · Red 2 Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Very sensitive to moisture so should be left in individual foil wrapping.
9 November 2015
Lactation Safety Information
Direct thrombin inhibitor
Very limited published evidence of safety indicates low levels in milk
Minimal absorption from the infant’s GI tract expected due to low oral bioavailability
Monitor infant for bleeding and bruising
13 August 2020
PradaxaVenous thromboembolism (VTE) from birth to <18 years of age
Licence extension / variation and new formulation
Development and Regulatory status
Recommended for approval (Positive opinion)
Recommended for approval (Positive opinion)
Jun 21Approval is for oral pellets to treat children age 3 months to <12 years and for capsules to treat patients age ≥8 years, with VTE after parenteral anticoagulation for ≥5 days, and also for prevention of recurrent clots in those who have completed treatment for their first VTE .
Jun 21Approved in US for only children 3 months to less than 12 years old .
Nov 20Recommended for EU approval by CHMP - the additional indication is "Treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age." Indications for all dose forms now include "For age appropriate dose forms, see section 4.2." A contra-indication of "eGFR <50 mL/min/1.73m2 in paediatric patients" is added for all dose forms, and new dose forms of an oral liquid plus oral coated granules in a range of strengths have been licensed .
Aug 20Currently pre-registration in EU. Has been filed using the centralised procedure; estimated CHMP opinion in Oct 20 .
The incidence of VTE is 1-2 per 1,000 of the population and the risk increases with age. One in 20 people will have a VTE at some time in their life. Approximately half of patients presenting with VTE have been hospitalised in the previous eight weeks .
Venous thromboembolism (VTE) from birth to <18 years of age
Trial or other data
Dec 20Diversity RCT (n=328) found age/weight adjusted dabigatran non-inferior to standard of care (LMWH/unfractionated heparin/vit K antagonists/fondaparinux) for the composite efficacy endpoint of thrombus resolution, & no recurrent VTE or VTE-death: 42%vs 46%; p<0.0001) .
Nov 19Boehringer completes the PII PIII Diversity (NCT01895777) trial .
Dec 18PIII Diversity trial is still recruiting subjects, with an estimated primary completion date of January 2020 .
Nov 17The PIII Diversity trial estimated primary completion date changed to 5 Nov 2018 
Jan 17The PIII Diversity trial (NCT01895777) is ongoing and still recruiting participants, with an estimated primary completion date of June 2018 
Jan 16PIII development is ongoing with the open-label (NCT01895777) still recruiting subjects. The estimated final data collection date for the primary outcome measure is March 2018 .
Jul 13NCT01895777 This is an open-label, randomized, active-controlled, multi-centre PIII non-inferiority study in 270 children from birth to < 18 years of age to assess the efficacy and safety of dabigatran vs standard of care (LMWH or vitamin K antagonists) for treatment of VTE. The study will also assess the appropriateness of the proposed dabigatran doses for use in paediatric patients using three different formulations (capsules, pellets and oral liquid formulation). The co-primary outcomes are: A combined endpoint of complete thrombus resolution plus freedom from recurrent VTE plus freedom from mortality related to VTE, and freedom from major bleeding events, both at 12 weeks. The study starts Sep 13 and is due to complete Mar 18 .