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.
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).
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.
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 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.
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