Revised SPC: Fibrogamin (blood coagulation factor XIII) 250/1250IU

electronic Medicines Compendium

Fibrogammin is now licensed for use in paediatric patients. The initial dose in congenital Factor XIII deficiency has been increased to 40 units per kg every 28 days, in both adult and paediatric patients.

Impact of proton pump inhibitor treatment on gastrointestinal bleeding associated with non-steroidal anti-inflammatory drug use among post-myocardial infarction patients taking antithrombotics: nationwide study

British Medical Journal

This large retrospective study found patients taking PPIs in addition to NSAID plus antithrombotics after MI had a lower risk of GI bleeding vs NSAID plus antithrombotics without PPI (1.8 vs 2.1 events per 100 person years; HR 0.72 95% CI = 0.54 to 0.95).

FDA approves idarucizumab (Praxbind), the first reversal agent for the anticoagulant dabigatran (Pradaxa)

US Food and Drug Administration

In healthy volunteers (n=283) given idarucizumab there was an immediate reduction in the amount of unbound dabigatran plasma lasting at least 24 hours. In another trial (n=123) dabigatran was fully reversed in 89% of patients within four hours of receiving idarucizumab.

Acute coronary syndromes

British Medical Journal

This review provides a comprehensive account of the pathophysiology, clinical presentation, management, and outcomes of acute coronary syndrome.

Drug problems: Dangerous decision-making at the FDA

Project on Government Oversight

This independent report alleges that the US FDA lowered its standards to ease approval of dabigatran and then deflected questions about its safety that arose after the drug entered clinical practice.

US FDA approves first Factor X concentrate (Coagadex®) to treat patients with hereditary Factor X (10) deficiency

US Food and Drug Administration

Coagadex, which is derived from human plasma, is indicated for patients aged ≥12 years with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in patients with mild hereditary Factor X deficiency.

Left Atrial Appendage Occlusion Device and Novel Oral Anticoagulants Versus Warfarin for Stroke Prevention in Nonvalvular Atrial Fibrillation: Systematic Review and Meta-Analysis of Randomized Controlled Trials

Circulation: Arrhythmia and Electrophysiology

Meta-analysis of 7 studies found stroke prevention with NOACs is superior to warfarin in patients with nonvalvular atrial fibrillation; and the Watchman left atrial appendage occlusion device was considered a reasonable noninferior alternative to warfarin.

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