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MHRA warning about anti-coagulant treatments

For Antiphospholipid syndrome, Venous thrombotic event, Deep vein thrombosis (DVT), Pulmonary embolism and Atrial fibrillation

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a warning regarding patients taking anti-coagulant therapies known as direct-acting oral anticoagulants (DOACs) who have antiphospholipid syndrome (APS).

Patients are warned that an increase in the risk of recurrent thrombotic events has been observed in clinical studies for patients taking the anti-coagulant rivaroxaban with a history of thrombosis. They state that other direct-acting oral anticoagulants (DOACs) may be associated with a similarly increased risk.

Antiphospholipid syndrome (APS), sometimes known as Hughes syndrome, is a disorder of the immune system that causes an increased risk of blood clots.

This means people with APS are at greater risk of developing conditions such as:
  • deep vein thrombosis (DVT), a blood clot that usually develops in the leg
  • arterial thrombosis (a clot in an artery), which can cause a stroke or heart attack
  • blood clots in the brain, leading to problems with balance, mobility, vision, speech and memory
Pregnant women with APS also have an increased risk of having a miscarriage, although the exact reasons for this are uncertain.

APS doesn't always cause noticeable problems, but some people have general symptoms that can be similar to those of multiple sclerosis (a common condition affecting the central nervous system).

The DOACs currently available are:
  • rivaroxaban - brand name Xarelto▼; used to prevent venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery, deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults
  • apixaban - brand name Eliquis; used to prevent venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery, prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, deep vein thrombosis and pulmonary embolism, and prevention of recurrent DVT and PE in adults
  • edoxaban - brand name Lixiana▼; used for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, deep vein thrombosis and pulmonary embolism, and prevention of recurrent DVT and PE in adults
  • dabigatran - brand name Pradaxa; used to treat primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery, prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, deep vein thrombosis and pulmonary embolism, and prevention of recurrent DVT and PE
DOACs are approved for the treatment and prevention of venous thromboembolism (VTE) and prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation with one or more risk factors. Apixaban, dabigatran etexilate, and rivaroxaban are also approved for prevention of venous thromboembolism in conjunction with hip or knee replacement surgery.

Rivaroxaban is also approved, in addition to acetylsalicylic acid (aspirin), for the prevention of atherothrombotic events in patients with coronary artery disease or symptomatic peripheral artery disease at high risk of ischaemic events, and in addition to acetylsalicylic acid or acetylsalicylic acid plus clopidogrel or ticlopidine, in patients after an acute coronary syndrome event with elevated cardiac biomarkers.

Advice for healthcare professionals (from MHRA):
  • direct-acting oral anticoagulants (DOACs) are not recommended in patients with antiphospholipid syndrome, particularly high-risk patients (those who test positive for all 3 antiphospholipid tests — lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2 glycoprotein I antibodies)
  • review whether continued treatment with a DOAC is appropriate for patients diagnosed with antiphospholipid syndrome, particularly high-risk patients, and consider switching to a vitamin K antagonist such as warfarin
  • report suspected adverse drug reactions to DOACs on a Yellow Card, including any thromboembolic events suspected to be due to lack of efficacy
Eliquis was first made available in the EU in 2011. It is manufactured by Bristol-Myers Squibb-Pfizer.
Xarelto▼ was first approved for use in the EU in 2008. It is manufactured by Bayer.
Lixiana▼ was first approved for use in the EU in 2015. It is manufactured by Daiichi Sankyo.
Pradaxa was first approved for use in the EU in 2008. It is manufactured by Boehringer Ingelheim.

Sources
European Medicines Agency website page for Eliquis, Xarelto, Lixiana and Pradaxa
NHS website for antiphospholipid syndrome
Contains public sector information licensed under the Open Government Licence v3.0.
Accessed 24/06/19
Links available in full article

MHRA information on direct-acting oral anticoagulants (DOACs)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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