Revised SPC: Xarelto (rivaroxaban) 2.5 mg film-coated tablets

electronic Medicines Compendium

Additions include advice on how to reduce the potential bleeding risk associated with concurrent use of rivaroxaban and neuraxial anaesthesia or spinal puncture (section 4.4) and post-marketing adverse events of cholestasis, hepatitis and thrombocytopenia (section 4.8).

 

Six Months vs Extended Oral Anticoagulation After a First Episode of Pulmonary Embolism: The PADIS-PE Randomized Clinical Trial

Journal of the American Medical Association

This RCT of adults with a first unprovoked PE who had already received 6 months of warfarin found that extended treatment (further 18 months) reduced the composite outcome of recurrent VTE and major bleeding (3.3% v 13.5% placebo).

 

A practical guideline for the haematological management of major haemorrhage

British Journal of Haematology

This guideline provides recommendations for the haematological management of major haemorrhage in any clinical situation, with practical guidance on the content and delivery of major bleeding protocols, including the use of blood components and transfusion alternatives.

 

Atrial flutter and thromboembolic risk: a systematic review

Heart

This analysis of 52 studies (observational; no RCTs) confirms clinical thromboembolic events are highly prevalent in atrial flutter. The authors say thromboprophylaxis should strongly be considered in the presence of ≥1 additional stroke risk factors.

 

Antiplatelet therapy as a modulator of stroke aetiology: a meta-analysis

British Journal of Clinical Pharmacology

This meta-analysis (9 studies; n=5739) evaluating antiplatelet therapy (APT) on incidence of each subtype of stroke: large artery atherosclerosis (LAA), cardioembolic and small vessel occlusion concluded that APT preferentially reduces the incidence of LAA stroke.

 

Anticoagulant vs. antiplatelet therapy in patients with cryptogenic stroke and patent foramen ovale: an individual participant data meta-analysis

European Heart Journal

This meta-analysis of 804 patients on oral anticoagulants and 1581 patients on antiplatelets did not find a statistically significant difference between the two groups for stroke/TIA or death in patients being treated for cryptogenic stroke or patent foramen ovale.

 

The clinical effectiveness and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonists

National Institute for Health Research

An analysis of 26 RCTs found that compared with standard monitoring, self-monitoring appears to be safe and effective, especially for people with artificial heart valves.

 

FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

US Food and Drug Administration

Following a comprehensive review of new safety information, the FDA is requiring updates to the drug labels of all prescription NSAIDs, to strengthen an existing label warning that NSAIDs increase the chance of a heart attack or stroke.

 

Antithrombotic therapy in the elderly: expert position paper of the European Society of Cardiology Working Group on Thrombosis

European Heart Journal

This paper discusses pharmacokinetic and pharmacodynamic variables influencing the efficacy and safety of drugs in elderly subjects and makes recommendations regarding use of oral and IV antiplatelets and anticoagulants and how to prevent and manage bleeding in the elderly.

 

 

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:

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New product: Edoxaban (Lixiana) 60mg Film-Coated Tablets

electronic Medicines Compendium

Licensed for prevention of stroke and systemic embolism in adults with non valvular AF with 1 or more risk factors such as CHF, HBP, age ≥ 75 years, DM, prior stroke or TIA, prevention of recurrent DVT/PE, and treatment of DVT/PE.

 

Revised SPC: Rivaroxaban (Xarelto) 10 and 20mg tablets

electronic Medicines Compendium

Advice on how to reduce the potential bleeding risk associated with concurrent use of rivaroxaban and neuraxial (epidural/spinal) anaesthesia or spinal puncture have been added. The following AEs are now listed: cholestasis, hepatitis and thrombocytopenia.

 

Cohort study of Anticoagulation Self-Monitoring (CASM): a prospective study of its effectiveness in the community

British Journal of General Practice

This UK cohort study of 296 adults self-monitoring their oral anticoagulation therapy (median 61 years; predominately professional or held a university qualification) found 90.2% were still self-monitoring after 12 months, with a mean time in therapeutic range of 75.3%.

 

How to Monitor Patients Receiving Direct Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation: A Practice Tool

Annals of Internal Medicine

This tool advocates regular, standardised clinical monitoring of patients receiving novel oral anticoagulants. It consists of a checklist covering adherence assessment and counselling, bleeding risk assessment, creatinine clearance, drug interactions and examination (e.g. BP).

 

Socioeconomic Inequalities in the Prescription of Oral Anticoagulants in Stroke Patients With Atrial Fibrillation

Stroke

This analysis of the Swedish stroke register found the prescribing of anticoagulants after stroke in patients with AF varied according to age, income, education and country of birth. This was not explained by common risk factors suggesting socioeconomic inequalities.

 

 

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

High-dose ibuprofen (≥2400mg/day): small increase in cardiovascular risk

Medicines and Healthcare products Regulatory Agency

EU review confirms that CV risk of high-dose ibuprofen (≥2400mg/day) is similar to COX 2 inhibitors and diclofenac. Clinicians are advised that naproxen and low-dose ibuprofen (≤1200mg per day) are considered to have most favourable thrombotic CV safety profiles of all NSAIDs.

 

Meta-analysis of Comparison of the Newer Oral P2Y12 Inhibitors (Prasugrel or Ticagrelor) to Clopidogrel in Patients with Non-ST-elevation Acute Coronary Syndrome

American Journal of Cardiology

Review of 4 RCTs (n=31,470 with NSTE-ACS) found newer oral P2Y12 inhibitors decrease major cardiovascular events (MACEs) and MI at expense of significant increase in bleeding risk. Treatment of 1000 patients will prevent 16 MACEs at expense of increase in 6 major bleeds.

 

Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? A systematic review and economic evaluation

BMJ Open

Review of 26 RCTs (n=8763) suggests self-monitoring (SM) appears to be a safe and cost-effective option. It found that both SM and self-testing were as safe as standard care (SC) in terms of major bleeding events. SM was also linked to fewer thromboembolic events vs. SC.

 

Prevalence, Clinical Features, and Prognosis of Acute Myocardial Infarction Due to Coronary Artery Embolism

Circulation

Of 1776 Japanese patients who presented with de novo AMI between 2001 and 2013, prevalence of coronary artery embolism (CE) was 2.9% (n=52). AF was the most common cause (n=38, 73%). Only 39% of patients with CE were treated with vitamin K antagonists, and median INR was 1.42.

 

Association of Rivaroxaban Anticoagulation and Spontaneous Vitreous Hemorrhage

JAMA Opthalmology

This report describes 3 patients who developed spontaneous vitreous haemorrhage after initiating rivaroxaban. All 3 patients were taking an additional antithrombotic agent (2 warfarin, 1 clopidogrel) at the time of haemorrhage.

 

CHMP adopts positive opinion on licence extension of Voncento (human coagulation factor VIII / von Willebrand factor) in EU

European Medicines Agency

The licence extension will be for prophylaxis and treatment of haemorrhage or surgical bleeding in patients with von Willebrand Disease, when desmopressin treatment alone is ineffective or contraindicated.

 

Revised SPC: Konakion (phytomenadione) MM (10mg/ml and Paediatric 2 mg/0.2 ml)

electronic Medicines Compendium

SPC notes reports of anaphylactoid reactions after IV injection. Local irritation may occur at injection site but is unlikely due to the small injection volume. Rarely, injection site reactions may occur which may be severe, including inflammation, atrophy and necrosis.

 

Apixaban Compared with Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Findings From the ARISTOTLE Trial

Circulation

Analysis (n=18,201 of which 4808 had valvular heart disease [VHD]) or prior valve surgery found no evidence of differential effect of apixaban over warfarin in patients with and without VHD in reducing stroke and systemic embolis, causing less bleeding, and reducing death.

 

Characterising and predicting bleeding in high-risk patients with an acute coronary syndrome

Heart

Analysis of APPRAISE-2 study (n=7392) found that when compared with placebo, use of apixaban is linked to an important short-term and long-term risk of bleeding in high-risk post-ACS patients, with GI bleeding being most common source of major bleeding.

 

Superficial thrombophlebitis (superficial venous thrombosis)

British Medical Journal

This reviews covers epidemiology, diagnosis, causes, types of superficial thrombophlebitis, complications, investigations, treatment (hosiery, NSAIDs, anticoagulation, antibiotics, surgery), and when to refer.

 

Edoxaban (Lixiana) approved in EU for stroke prophylaxis and prevention and treatment of venous thromboembolism

PharmaTimes

Edoxaban is a once-daily selective factor Xa-inhibitor which has been licensed for prevention of stroke and systemic embolism in patients with nonvalvular AF with one or more risk factors; and treatment and prevention of DVT and pulmonary embolism.

 

Venous thromboembolism in adults admitted to hospital: reducing the risk - guideline (CG92)

National Institute for Health and Care Excellence

This guidance is about the care and treatment of adults who are at risk of developing deep vein thrombosis (DVT) while in hospital in the NHS in England and Wales. It should be read in conjunction with TA 245 (published in January 2012).

 

Preliminary findings from the GARFIELD-AF registry show poor anticoagulation control and high risk scores increase mortality and strokes in newly diagnosed AF patients

Biospace Inc.

Preliminary results from GARFIELD-AF study (n=17,200) presented at the International Society on Thrombosis and Haemostasis conference have shown that fewer patients diagnosed at a hospital have good anticoagulant control vs patients diagnosed at an office/anticoagulation clinic.

 

Idarucizumab for Dabigatran Reversal

New England Journal of Medicine

Interim results of the RE-VERSE AD cohort study (n=90) show that idarucizumab (5g IV) rapidly and completely reversed the anticoagulant activity of dabigatran in 88 to 98% of those with elevated clotting times at baseline.

 

Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation

New England Journal of Medicine

In AF patients requiring warfarin interruption for an elective procedure, no bridging (placebo) was non-inferior to dalteparin bridging for the prevention of arterial thromboembolism (incidence of 0.4% v 0.3%) and decreased the risk of major bleeding (1.3% v 3.2%).

 

Positive Phase III data for anticoagulant antidote andexanet alfa

PharmaTimes

In Phase III ANNEXA-A trial, andexanet alfa rapidly reversed the anticoagulant effect of apixaban by 93.5%, and sustained a high level of efficacy across the two-hour infusion period. No serious adverse events were reported.

 

 

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

Thromboembolic Complications and Prophylaxis Patterns in Colorectal Surgery

JAMA Surgery

US study of 16,120 patients who had undergone colorectal surgery found venous thromboembolism rates are low and largely unchanged despite increases in peri-and postoperative prophylaxis. With ~40% events occurring after discharge, this represents an area for quality improvement.

 

Interventions for prophylaxis of hepatic veno-occlusive disease in people undergoing haematopoietic stem cell transplantation

Cochrane Database of Systematic Reviews

There is low quality evidence that ursodeoxycholic acid may reduce incidence of disease, all-cause mortality and mortality in HSCT recipients. There is insufficient evidence to support use of heparin, LMWH, defibrotide, glutamine, FFP, antithrombin III, and PGE1.

 

Revised SPC: Plavix (clopidogrel) 75mg tablets

electronic Medicines Compendium

In section 4.5 (interactions), the list of CYP2C19 inhibitors has been amended so that it now only lists examples of strong or moderate inhibitors (ciprofloxacin, cimetidine, oxcarbazepine and chloramphenicol have been removed).

 

Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial

The Lancet

In a proof-of-concept study in healthy volunteers, idarucizumab (monoclonal antibody fragment that binds dabigatran) was found to immediately and completely reverse dabigatran-induced anticoagulation in a dose-dependent manner.

 

Doctors call on health secretary to intervene in release of all data on alteplase for acute ischaemic stroke

British Medical Journal

Some doctors have been questioning efficacy and safety of alteplase —and methodology of some of trials assessing it. Unpublished data are still missing on certain endpoints including early mortality. The MHRA is due to publish a review on alteplase towards end of 2015.

 

 

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

Guideline on aspects of cancer-related venous thrombosis

British Committee for Standards in Haematology

This aims to provide healthcare professionals with clear guidance on prevention and management of venous thromboembolism (VTE) in patients with cancer and to advise on an approach to screening for cancer in patients with unprovoked VTE in whom cancer was not initially suspected.

 

Restarting Anticoagulant Treatment After Intracranial Haemorrhage in Patients With Atrial Fibrillation and the Impact on Recurrent Stroke, Mortality and Bleeding: A Nationwide Cohort Study

Circulation

Danish study (n=1752) found AF patients with intracranial haemorrhage (ICH) are at very high risk of ischaemic stroke/mortality, if not on antithrombotic. Oral anticoagulant was linked to reduction in this risk, supporting feasability of its reintroduction post-ICH.

 

Drug-related problems in a clinical setting: a literature review and cross-sectional study evaluating factors to identify patients at risk

European Journal of Hospital Pharmacy

A narrative review of 21 papers found that although risk factors associated with drug-related problems (DRPs) differed greatly among these publications, comorbidity, polypharmacy and the use of specific drugs (antithrombotics, antidiabetics) were frequently associated with DRPs.

 

 

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

Why do electronic health records reveal oral anticoagulant prescription after haemorrhagic stroke?

British Journal of Clinical Pharmacology

There were 134 (1.2%) subjects with electronic health records documenting previous haemorrhagic stroke (HS) prescribed warfarin during a trial. Researchers found that in ~50% patients, stroke event was miscoded as HS when physician-reported diagnosis was of cerebral infarction.

 

Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial

The Lancet

This study (n=21,105) found tailoring dose of edoxaban on basis of clinical factors alone prevents excess drug levels and helps to optimise risk of ischaemic and bleeding events. Data also showed that therapeutic window for edoxaban is narrower for major bleeding than thromboembolism.

 

Genetics and the clinical response to warfarin and edoxaban: findings from the randomised, double-blind ENGAGE AF-TIMI 48 trial

The Lancet

Analysis of 4833 subjects taking warfarin found that CYP2C9 and VKORC1 genotypes identify patients who are more likely to experience early bleeding with warfarin and who derive a greater early safety benefit from edoxaban compared with warfarin during first 90 days.

 

Apixaban for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism- technology appraisal guidance [TA341]

National Institute for Health and Care Excellence

Guidance recommends apixaban, within its marketing authorisation, as an option for treating and for preventing recurrent deep vein thrombosis and pulmonary embolism in adults.

 

Early Medication Nonadherence After Acute Myocardial Infarction

Circulation

Analysis of 7425 acute MI patients treated with PCI at 216 US hospitals found that a substantial proportion report suboptimal adherence to prescribed medications, soon after MI. Moderate and low adherence was reported in 25% and 4% of patients, respectively, at 6 weeks post MI.

 

Non-vitamin K antagonist oral anticoagulants and major bleeding-related fatality in patients with atrial fibrillation and venous thromboembolism: a systematic review and meta-analysis

European Heart Journal

Meta-analysis found NOACs (apixaban, dabigatran, edoxaban, rivaroxaban) decrease risk of fatal bleeding by 47%, case fatality due to major bleeding by 32% and all-cause mortality after a bleeding event by 43% vs. vitamin K antagonists.

 

Progress in Intravenous Thrombolytic Therapy for Acute Stroke

JAMA Neurology

This review traces the development of IV thrombolysis to date, considers the shortcomings of alteplase, and examines alternative thrombolytic approaches currently in the pipeline, including the role of neuroimaging and the possibility of combination therapies.

 

 

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

Liver injury with novel oral anticoagulants: assessing post-marketing reports in the US Food and Drug Administration adverse event reporting system

British Journal of Clinical Pharmacology

Reports of drug-induced liver injury associated with NOACs including acute liver failure events represented 3.7% (n = 146) and 1.7% (n = 222) of all reports for rivaroxaban and dabigatran, respectively. Disproportionality signals emerged for rivaroxaban in primary analysis.

 

Bleeding, Recurrent Venous Thromboembolism, and Mortality Risks During Warfarin Interruption for Invasive Procedures

JAMA Internal Medicine

This retrospective cohort study of patients whose warfarin therapy was interrupted for invasive diagnostic or surgical procedures (total 1812) found use of bridging increased the rate of clinically relevant bleeding (2.7% v 0.2% in those with no bridging); VTE rates were similar.

 

Standard vs Modified Antiplatelet Preparation for Preventing Thromboembolic Events in Patients With High On-Treatment Platelet Reactivity Undergoing Coil Embolization for an Unruptured Intracranial Aneurysm: A Randomized Clinical Trial

JAMA Neurology

This single-centre study reports that in patients undergoing coiling for unruptured aneurysms, use of a modified antiplatelet regimen for those with high on-treatment platelet reactivity reduced the rate of thromboembolic events vs. standard antiplatelet therapy.

 

Longer Versus Shorter Duration Dual-Antiplatelet Therapy After Drug-Eluting Stent Placement: A Systematic Review and Meta-analysis

Annals of Internal Medicine

This review of 9 RCTs reports that longer-duration dual antiplatelet therapy (DAPT) following drug-eluting stent placement reduced MI risk (RR 0.73, 95% CI 0.58-0.92) but increased mortality (1.19, 1.04-1.36) and major bleeding risk (1.63, 1.34-1.99]) vs. shorter-duration DAPT.

 

 

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

Risk of Substantial Intraocular Bleeding With Novel Oral Anticoagulants: Systematic Review and Meta-analysis

JAMA Oncology

Analysis of 17 RCTs suggests no differences exist in the risk of substantial intraocular bleeding between NOACs and other antithrombotic drugs (vitamin K antagonists, aspirin, low-molecular-weight heparin). However, the number of events was scarce so further studies are needed.

 

Stroke Prevention in Atrial Fibrillation: A Systematic Review

Journal of the American Medical Association

This review highlights that stroke prevention is central to management of AF, irrespective of a rate or rhythm control strategy. Following the initial
focus on identifying low-risk patients, all others with 1 or more stroke risk factors should be offered oral anticoagulation.

 

The Association of Discharge Aspirin Dose With Outcomes After Acute Myocardial Infarction: Insights From the TRANSLATE-ACS Study

Circulation

US study of 10,213 MI patients who underwent PCI and were discharged on dual antiplatelet therapy found that high maintenance dose aspirin (325mg) was linked to similar rates of major adverse cardiovascular events but greater risk of minor bleeding vs. low-dose aspirin (81mg).

 

Efficacy and Harms of Direct Oral Anticoagulants in the Elderly for Stroke Prevention in Atrial Fibrillation and Secondary Prevention of Venous Thromboembolism: Systematic Review and Meta-Analysis

Circulation

Direct oral anticoagulants demonstrate at least equal efficacy to VKAs in managing thrombotic risks in the elderly although bleeding patterns were distinct with dabigatran linked to a particularly higher risk of GI bleeding compared to VKAs.

 

The prognostic utility of tests of platelet function for the detection of ‘aspirin resistance’ in patients with established cardiovascular or cerebrovascular disease: a systematic review and economic evaluation

National Institute for Health Research

This systematic review evaluated whether or not 'aspirin resistance' defined using platelet function tests (PFTs) was linked to occurrence of adverse clinical outcomes and concluded that studies investigating this were of inconsistent quality - no firm conclusions could be made.

 

Efficacy of Prophylactic Low–Molecular Weight Heparin for Ambulatory Patients With Advanced Pancreatic Cancer: Outcomes From the CONKO-004 Trial

Journal of Clinical Oncology

In patients with advanced pancreatic cancer undergoing chemotherapy, prophylactic enoxaparin was associated with a reduced rate of symptomatic VTE (6.4% vs 15.1% with no enoxaparin) and no increase in major bleeding; there was no difference in progression-free or overall survival.

 

 

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

 

Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation

European Heart Journal

RCT (n=248; VENTURE-AF) found that use of uninterrupted rivaroxaban was feasible and bleeding and thromboembolic event rates were similar to those for uninterrupted vitamin K antagonists in patients with non-valvular atrial fibrillation undergoing catheter ablation.

 

Edoxaban vs. warfarin in patients with atrial fibrillation on amiodarone: a subgroup analysis of the ENGAGE AF-TIMI 48 trial

European Heart Journal

In pre-specified subgroup analysis, patients randomised to lower dose edoxaban (DE) who were taking amiodarone at baseline had fewer ischaemic events compared with warfarin vs. patients not on amiodarone. Also amiodarone had no effect on relative efficacy and safety of higher DE.

 

 

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

50 year trends in atrial fibrillation prevalence, incidence, risk factors, and mortality in the Framingham Heart Study: a cohort study

The Lancet

In this analysis (202,417 person-yrs), a roughly 4-times increase in age-adjusted incidence and prevalence of AF in both sexes was reported. Risk of AF in both sexes doubled with each decade of age, and risk of stroke and death after diagnosis were equivalent between the sexes.

 

Antiplatelet therapy following transcatheter aortic valve implantation

Heart

Systematic review and pooled analysis of individual patient data (n=672) found no difference in 30-day net adverse clinical and cerebral events rate between aspirin-only or dual antiplatelet therapy following transcatheter aortic valve implantation.

 

Oral Anticoagulation, Aspirin, or No Therapy in Patients With Nonvalvular AF With 0 or 1 Stroke Risk Factor Based on the CHA2DS2-VASc Score

Journal of the American College of Cardiology

Study (n=39,400) found low-risk patients (CHA2DS2-VASc=0 [male],1 [female]) have a truly low risk for stroke and bleeding. With 1 additional stroke risk factor (score 1 & 2 respectively), there was significant increase in event rates (particularly mortality) if non-anticoagulated.

 

Gender differences in the effect of cardiovascular drugs: a position document of the Working Group on Pharmacology and Drug Therapy of the ESC

European Heart Journal

This position paper discusses the gaps in knowledge on the effects of gender on pharmacokinetics and pharmacodynamics of cardiovascular drugs, and how such differences may influence their effectiveness and safety.

 

Low-Molecular-Weight Heparin for Women With Unexplained Recurrent Pregnancy Loss: A Multicenter Trial With a Minimization Randomization Scheme

Annals of Internal Medicine

In 449 women with unexplained recurrent pregnancy loss, a daily injection of LMWH (dalteparin 5000IU) for up to 24 weeks' gestation did not improve the rate of ongoing pregnancy at 24 weeks (86.8% v 87.9%) or the live birth rate (86.0% v 86.7%) v control.

 

EMA approves Raplixa™ powdered fibrin sealant for surgical bleeding

European Medicines Agency

The EMA has approved Raplixa™ (fibrin sealant) for use in adults as a supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis. It must be used in combination with an approved CE marked gelatin sponge (supplied separately).

 

 

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

 

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