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Saturday, 12 July 2014 08:33

Anticoagulation news items. Week commencing 7th July 2014

Revised SPCs: Pradaxa (dabigatran) 150mg, 110mg and 75mg hard capsules

Electronic Medicines Compendium
The SPCs have been extensively revised following addition of a new indication for use of dabigatran in the treatment of DVT and PE and prevention of recurrent DVT and PE in adults. Wording for the interaction with verapamil has been strengthened in view of bleeding risk.


Long-Acting clotting Factor VIIa-CTP receives positive opinion for three orphan drug designations in Europe

Biospace Inc.
This positive opinion recommends approval of orphan drug designation for long-acting version of clotting Factor VIIa (IV or SC route) for treatment of bleeding episodes in patients with haemophilia A or B with inhibitors to Factor VIII or IX and congenital Factor VII deficiency.


Antipsychotic drugs and risks of myocardial infarction: a self-controlled case series study

European Heart Journal
This study suggests an increased MI risk during the 30 days after first prescription of an antipsychotic. Although the small absolute risk is unlikely to alter risk/benefit balance in licensed conditions, it is likely to be less favourable for unlicensed uses (e.g. dementia).


Quadrivalent Human Papillomavirus Vaccine and the Risk of Venous Thromboembolism

Journal of the American Medical Association
This self-controlled case-series found no evidence for an increased risk of venous thromboembolism during the 42 days after quadrivalent HPV vaccination. The lack of association was apparent in subgroup analyses according to age, and after adjustment for oral contraceptive use.


Low molecular weight heparin versus unfractionated heparin for perioperative thromboprophylaxis in patients with cancer

Cochrane Database of Systematic Reviews
No evidence was found between perioperative thromboprophylaxis with LMWH versus UFH in their effects on mortality, thromboembolic outcomes, major or minor bleeding in patients with cancer. Further trials are needed to evaluate different heparin thromboprophylaxis strategies.


Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial

The Lancet
This pragmatic study in patients undergoing primary PCI found that the incidence of major cardiac adverse events (MACE) at 28 days was lower with heparin than with bivalirudin (5.7% vs. 8.7%, respectively; p=0.01), with no difference between groups in bleeding complications.



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: