Revised SPC: FEIBA (Factor VIII Inhibitor Bypassing Activity) 500 U powder and solvent for solution for infusion

electronic Medicines compendium

Sections 4.4 and 4.5 now advise isohemagglutinins may interfere with serological tests. Additionally, the SPC advises of increased risk of thrombotic microangiopathy with FEIBA in patients receiving emicizumab prophylaxis.

Revised SPC: Revolade (eltrombopag) film-coated tablets – all strengths

electronic Medicines compendium

The SPCs have been updated with information related to liver functions tests, thrombotic and thromboembolic complications and myelodysplastic syndrome.

Direct oral anticoagulants in patients with venous thromboembolism and thrombophilia: a systematic review and meta‐analysis

Journal of Thrombosis and Haemastasis

Review of 8 studies reporting data on 1994 thrombophilia patients found no statistically significant differences in rate of VTE recurrence for DOACs vs vitamin K antagonists (RR 0.79, 95% 0.34-1.44). Bleeding event rates were similar (0.92, 0.62 to 1.36).

Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation

New England Journal of Medicine

2 x 2 factorial RCT (n=4,614) found that in those with AF and a recent MI or PCI on a P2Y12 inhibitor; apixaban, without aspirin, resulted in less bleeding and without affecting the incidence of ischaemic events vs regimens including a vitamin K antagonist and/or aspirin.

Direct Oral Anticoagulant (DOAC) Dosing in renal impairment

Drug and Therapeutics Bulletin

In light of > 4,000 yellow card reports of DOAC-associated haemorrhagic events since their launch, the author of this editorial highlights the urgent need for national guidance to help clinicians prescribe DOACs safely, particularly for patients with declining renal function.

Bayer and Janssen pay $775m to settle more than 25 000 lawsuits in US over rivaroxaban misinformation claims

British Medical Journal
Cardiovascular system disorders | Haematological disorders
Neither company admitted liability. Most plaintiffs argued that rivaroxaban's labelling and instructions did not provide adequate information about risk to patients and clinicians. Janssen said labelling had been approved by US FDA and "clearly communicated benefits and risks."

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services