Dear Doctor Letter (Rote-Hand-Brief) on Eliquis®, Pradaxa®, Lixiana®/Roteas® and Xarelto®: use is not recommended in patients with antiphospholipid syndrome
2019.05.23
Active substance: apixaban | dabigatran etexilate | edoxaban | rivaroxaban
In coordination with the Federal Institute for Drugs and Medical Devices (BfArM), the European Medicines Agency (EMA) the companies Bayer AG, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer EEIG and Daiichi Sankyo Europe would like to inform you about the following:
In patients with a history of thrombosis diagnosed with antiphospholipid syndrome (APS) use of rivaroxaban has been associated with an increased risk of recurrent thrombotic events, compared with warfarin.
Other DOACs (apixaban, edoxaban and dabigatran etexilate) may also be associated with an increased risk of recurrent thrombosis compared to vitamin K antagonists such as warfarin or phenprocoumone. The use of DOACs is not recommended in patients with APS, especially in high-risk patients.
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