Dabigatran

Red

Brand Name(s):Pradaxa

Indication:VTE prophylaxis in hip and knee replacements

Rationale:1,8

Considered:Nov-08

Review Date:Jul-24

Comments:
NICE TA327
Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism
Guidance can be found at:
https://www.nice.org.uk/guidance/ta327/resources/guidance-dabigatran-etexilate-for-the-treatment-and-secondary-prevention-of-deep-vein-thrombosis-andor-pulmonary-embolism-pdf
Dec2014
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Risk of haemorrhage
Prescribers should note guidance issued by MHRA regarding risk of serious haemorrhage with the new oral anticoagulant drugs (NOAC’s). Guidance contains updated information on contraindications and warnings for use.

MHRA guidance available at: http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con321961.pdf
Issued October 2013

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Dabigatran (Pradaxa): contraindicated in patients with prosthetic heart valve(s) requiring anti-coagulant treatment, because of the risk of thrombosis and haemorrhage
Summary
Dabigatran (Pradaxa) is now contraindicated in patients with prosthetic heart valves requiring anti-coagulant treatment related to their valve surgery. This is regardless of the length of time elapsed since valve replacement took place.
The contraindication is based on new clinical trial data in this population, which showed an increased frequency of thromboembolic and bleeding events in the group of patients treated with dabigatran, compared with warfarin.
MHRA Drug Safety Update – March 2013 (Volume 6, Issue 8)