Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents (MHRA release June 2020)

Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks. Specific reversal agents are available for dabigatran (Praxbind▼, idarucizumab), and apixaban and rivaroxaban (Ondexxya▼, andexanet alfa).

Further information can be found in the MHRA Drug Safety Update


Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome (MHRA release June 2019)

A clinical trial has shown an increased risk of recurrent thrombotic events associated with rivaroxaban compared with warfarin, in patients with antiphospholipid syndrome and a history of thrombosis. Other direct-acting oral anticoagulants (DOACs) may be associated with a similarly increased risk.

Further information can be found in the MHRA Drug Safety Update


Dabigatran (Pradaxa): contraindicated in patients with prosthetic heart valve(s) requiring anti-coagulant treatment (MHRA release December 2014)

Risk of thrombosis and haemorrhage in patients with prosthetic heart valve(s) requiring anti-coagulant treatment.

Further information can be found in the MHRA Drug Safety Update


Dabigatran (Pradaxa▼): risk of serious haemorrhage (MHRA release December 2014)

Dabigatran is contraindicated in clinical conditions associated with a significant risk of bleeding. Renal function should be assessed in all patients before starting dabigatran and at least once a year in patients older than 75 years or those with a suspected decline in renal function. Dabigatran is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min).

Further information can be found in the MHRA Drug Safety Update