FDA issues Class I recall for Roche Diagnostics ’ warfarin test strips
The FDA today issued a Class I recall for certain lots of Roche Diagnostics‘ warfarin test strips used with the CoaguCheck test meter devices. Roche voluntarily recalled the strips in September, warning that for patients and doctors who use at-home devices to monitor levels of the blood thinner, the devices may yield inaccurate results. The FDA said today that the devices should not be used to adjust drug dosages. Get the full story at our sister site, Drug Delivery Business News. The post FDA issues Class I recall for Roche Diagnostics’ warfarin test strips appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 2, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diagnostics Food & Drug Administration (FDA) Pharmaceuticals Recalls Regulatory/Compliance Vascular Wall Street Beat Roche Diagnostics Source Type: news

FDA recalls devices over inaccurate warfarin test results
The Food and Drug Administration announced a recall of test strips that monitor levels of the blood thinner wafarin may give inaccurate results. (Source: Health News - UPI.com)
Source: Health News - UPI.com - November 2, 2018 Category: Consumer Health News Source Type: news

FDA recalls test strips over inaccurate warfarin test results
The Food and Drug Administration has announced a recall of test strips that monitor levels of the blood thinner warfarin because they may give inaccurate results. (Source: Health News - UPI.com)
Source: Health News - UPI.com - November 2, 2018 Category: Consumer Health News Source Type: news

Warfarin INR Test Strips Recalled
(MedPage Today) -- Class I recall for over 1.1 million packages of CoaguChek XS PT strips (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - November 2, 2018 Category: American Health Source Type: news

FDA: Class I Recall of Roche Warfarin INR Test Strips FDA: Class I Recall of Roche Warfarin INR Test Strips
The problematic strips, used with CoaguChek anticoagulation meters, could lead to warfarin doses that are too low. Roche says it is issuing properly functioning replacements.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 2, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin
Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 1, 2018 Category: American Health Source Type: news

Dabigatran, Rivaroxaban, Warfarin in Oldest Adults With AF Dabigatran, Rivaroxaban, Warfarin in Oldest Adults With AF
This study compared the effectiveness and safety of reduced-dose dabigatran, reduced-dose rivaroxaban, and warfarin in individuals aged 85 and older with atrial fibrillation.Journal of the American Geriatrics Society (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 1, 2018 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Impact of a 4F-PCC Protocol in Warfarin-Associated ICH Impact of a 4F-PCC Protocol in Warfarin-Associated ICH
A pharmacist-driven 4F-PCC protocol for warfarin-associated intracranial hemorrhage may help reduce time to administration.Western Journal of Emergency Medicine: Integrating Emergency Care with Population Health (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - October 23, 2018 Category: Consumer Health News Tags: Emergency Medicine Journal Article Source Type: news

NOACs for Mechanical Heart Valves: Is the Door Still Open? NOACs for Mechanical Heart Valves: Is the Door Still Open?
Currently, NOACs are contraindicated in patients with mechanical heart valves based on the results of a single study comparing dabigatran and warfarin. Does this need to be re-evaluated?Circulation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - October 22, 2018 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Air pollution link to heightened mouth cancer risk
High levels of fine particulate matter seem key Related items fromOnMedica Lower cancer risk in people with higher vitamin D levels Global cancer burden set to soar Cancer survival rates not improved much in a decade Warfarin is not the answer for thromboses in cancer patients The NHS must adapt now to care for older cancer patients (Source: OnMedica Latest News)
Source: OnMedica Latest News - October 10, 2018 Category: UK Health Source Type: news

Meta-Analysis: Oral Anticoagulant Choice Matters in Afib Cardioversion
(MedPage Today) -- DOACs may be better than warfarin at preventing thromboembolic events (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - October 8, 2018 Category: Cardiology Source Type: news

Net Benefit of Anticoagulants for A - Fib Varies With Stroke Rate
Benefit of warfarin anticoagulation varies with varying published stroke rates (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - September 25, 2018 Category: Cancer & Oncology Tags: Cardiology, Internal Medicine, Oncology, Pharmacy, Journal, Source Type: news

Anticoagulation on Warfarin Weakens After 6 Months
(MedPage Today) -- But patients hitting TTR target still had fewer events (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - September 12, 2018 Category: Cardiology Source Type: news

Anticoagulation Control on Warfarin Weakens After 6 Months
(MedPage Today) -- But patients hitting TTR target still had fewer events (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - September 12, 2018 Category: Cardiology Source Type: news

Switching from warfarin reduces healthcare  use and costs
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - September 1, 2018 Category: Drugs & Pharmacology Source Type: news

Apixaban for AF in ESRD: Fewer Strokes, Major Bleeds vs Warfarin Apixaban for AF in ESRD: Fewer Strokes, Major Bleeds vs Warfarin
' I think this is the best data we have so far'supporting the use of apixaban in the especially high-risk population with atrial fibrillation, the lead researcher concludes. A randomized trial is forthcoming.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 31, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

More Bleeding on NOACs Seen in Kidney Disease? (CME/CE)
(MedPage Today) -- Stroke prevention similar to warfarin in observational study (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - July 12, 2018 Category: Primary Care Source Type: news

Apixaban Is Safest Direct Oral Anticoagulant Versus Warfarin
Reduced risks of major, intracranial, and gastrointestinal bleeding compared with warfarin (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - July 11, 2018 Category: Cancer & Oncology Tags: Cardiology, Family Medicine, Gastroenterology, Internal Medicine, Neurology, Oncology, Pharmacy, Journal, Source Type: news

Apixaban Is Safest Direct Oral Anticoagulant Versus Warfarin
WEDNESDAY, July 11, 2018 -- Apixaban seems to be the safest direct oral anticoagulant (DOAC) compared with warfarin, according to a study published July 4 in The BMJ. Yana Vinogradova, Ph.D., from the University of Nottingham in the United Kingdom,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 11, 2018 Category: Pharmaceuticals Source Type: news

HPV Versus Pap; DOACs and Warfarin: It's PodMed Double T! (with audio)
(MedPage Today) -- This week's topics include DOACs and warfarin, use of defibrillators after Department of Justice involvement, HPV testing versus Pap smears, and interfering with RNA in a genetic disease (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - July 7, 2018 Category: Cardiology Source Type: news

Cheap drug hope for 500,000 at risk of stroke
HALF a million Britons who are unknowingly at risk of a fatal stroke caused by an irregular heartbeat could be saved by cheap clot-busting drugs, according to research. A study in the European Heart Journal found that 4,000 strokes were prevented in England between 2015 and 2016 among patients with atrial fibrillation , a heart rhythm disorder, by taking anti-coagulants such as warfarin. (Source: Daily Express - Health)
Source: Daily Express - Health - July 5, 2018 Category: Consumer Health News Source Type: news

New blood-thinning drugs 'could be far safer than the commonly-prescribed warfarin'  
The study – published in the British Medical Journal – looked at 196,061 patients taking blood thinning drugs between 2011 and 2016 who were taking warfarin or the newer type drug. (Source: the Mail online | Health)
Source: the Mail online | Health - July 5, 2018 Category: Consumer Health News Source Type: news

Study Highlights Benefits of Newer Anticoagulants Study Highlights Benefits of Newer Anticoagulants
Newer oral anticoagulants, especially apixaban, are associated with a lower risk of major bleeds versus warfarin in patients with and without atrial fibrillation, a large UK study reveals.Medscape News UK (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 5, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

DOACs safer than warfarin, study suggests
New anti-clotting drugs appear to reduce risk of bleeding Related items fromOnMedica Self-monitoring cuts warfarin clot risk Rising use of antithrombotics linked to subdural haematoma Guided thrombolysis no better for treating DVT Direct oral anticoagulants as safe as warfarin after VTE Too few women take part in many CVD clinical trials (Source: OnMedica Latest News)
Source: OnMedica Latest News - July 5, 2018 Category: UK Health Source Type: news

New anti-clotting drugs linked to lower risk of serious bleeding
(BMJ) New drugs known as direct oral anticoagulants (DOACs) used to treat serious blood clots are associated with reduced risks of major bleeding compared with the older anti-clotting drug, warfarin, finds a study in The BMJ today. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 4, 2018 Category: International Medicine & Public Health Source Type: news

Real-World MI Risk Lower With NOACs vs Warfarin in AFib Real-World MI Risk Lower With NOACs vs Warfarin in AFib
The results, from a large registry, add to a growing body of evidence supporting the general safety of direct oral anticoagulants and may finally put to rest concerns about an MI signal with dabigatran.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 29, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

Danish Registry: NOACs Lower MI Risk More than Warfarin
(MedPage Today) -- Study clears the air on debate concerning direct-acting oral anticoagulants (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - June 26, 2018 Category: Cardiology Source Type: news

Reduced-Intensity Warfarin Safe With On-X Heart Valve Reduced-Intensity Warfarin Safe With On-X Heart Valve
Low-dose warfarin plus aspirin was associated with less bleeding without increasing thromboembolic events compared with standard-dose warfarin after aortic valve replacement with the On-X mechanical valve.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 21, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

Lower-Intensity Warfarin May be Safe with Surgical Mechanical Valve
(MedPage Today) -- Fewer bleeds with lower target INR, but dual antiplatelet therapy still a no-go (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - June 11, 2018 Category: Cardiology Source Type: news

Lower-Intensity Warfarin May be Safe with Surgical Mechanical Valve Designed for It
(MedPage Today) -- Fewer bleeds with lower target INR, but dual antiplatelet therapy still a no-go (Source: MedPage Today Surgery)
Source: MedPage Today Surgery - June 11, 2018 Category: Surgery Source Type: news

Roche launches CoaguCheck Vantus blood coagulation monitor
Roche (OTC:RHHBY) said today it is launching its CoaguCheck Vantus system designed for monitoring blood coagulation, specifically for patients on warfarin therapy. The Switzerland-based company said the CoaguCheck Vantus features built in Bluetooth technology to allow patients to use their smart devices and a compatible application to send results of the coagulation testing to their healthcare providers to reduce lab visits. Roche touted that the system can improve patient engagement and compliance, as well as establishing a better connection between patients and their doctors. “As healthcare systems face contin...
Source: Mass Device - June 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Patient Monitoring Roche Source Type: news

Roche launches CoaguChek Vantus to monitor coagulation levels wirelessly
As Pharma giant Roche continues its dive into the digital health realm, it is releasing a new self-testing device for INR or blood coagulation levels, that can wirelessly connect to a smartphone app. The CoaguChek Vantus system, which is designed for Warfarin patients to monitor their coagulation levels, includes built in Bluetooth technology. (Source: mobihealthnews)
Source: mobihealthnews - June 11, 2018 Category: Information Technology Source Type: news

Roche introduces first self-testing device for Warfarin monitoring with built in Bluetooth(R) technology
CoaguChek® Vantus system enables wireless reporting of INR results, making it easier for patients to accurately report their results INDIANAPOLIS, June 11, 2018 -- (Healthcare Sales & Marketing Network) -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announc... Devices, Monitoring, Product Launch Roche Group, CoaguChek, Vantus, coagulation, Warfarin, coumadin (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 11, 2018 Category: Pharmaceuticals Source Type: news

New Real-World Study Finds Long-Term XARELTO ® (rivaroxaban) Use Resulted in Fewer Strokes and Systemic Emboli Compared to Warfarin in Frail Patients with Non-Valvular Atrial Fibrillation
(Source: Johnson and Johnson)
Source: Johnson and Johnson - May 24, 2018 Category: Pharmaceuticals Source Type: news

Warfarin Class Tied to Higher Death Rate in COPD
(MedPage Today) -- Retrospective results shouldn't change practice, but deserve more study (Source: MedPage Today Allergy)
Source: MedPage Today Allergy - May 23, 2018 Category: Allergy & Immunology Source Type: news

Extended INR Test Intervals Safe for Warfarin-Treated Patients
WEDNESDAY, May 23, 2018 -- For stable warfarin-treated patients, extended international normalized ratio (INR) testing can be successfully and safely implemented, according to a study published online May 15 in the Journal of Thrombosis and... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 23, 2018 Category: Pharmaceuticals Source Type: news

Factor VIIa administration in traumatic brain injury: an AAST-MITC propensity score analysis - Lombardo S, Millar D, Jurkovich GJ, Coimbra R, Nirula R.
BACKGROUND: Recombinant factor VIIa (rFVIIa) has been used off-label as an adjunct in the reversal of warfarin therapy and management of hemorrhage after trauma. Only a handful of these reports are rigorous studies, from which results regarding safety and ... (Source: SafetyLit)
Source: SafetyLit - May 21, 2018 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Poor NOAC Adherence in AF Wreaks Havoc on Efficacy vs Warfarin Poor NOAC Adherence in AF Wreaks Havoc on Efficacy vs Warfarin
Benefits of novel oral anticoagulants that wowed in clinical trials may not carry over into clinical practice, when adherence to prescribed therapy usually declines, suggests an observational analysis.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 17, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

Low NOAC Adherence Worse Than Taking Warfarin?
(MedPage Today) -- Higher thromboembolic risk seen in observational data (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - May 14, 2018 Category: Cardiology Source Type: news

Blood Pressure Management Goals in Stroke Care
Blood pressure management goals in stroke care You arrive at a small rural emergency healthcare facility to transport a 72-year-old female who presents to the ED with the worst headache of her life. She’s to be transported to a tertiary center with neurosurgical services. Upon further questioning you determine her headache was sudden onset with maximum intensity. When reviewing her history and medications, you note that she’s currently on Coumadin (warfarin) with an international normalized ratio (INR) of 3.5, with the following vital signs noted on the monitor upon entering the room: blood pressure of 209/75 m...
Source: JEMS Patient Care - May 1, 2018 Category: Emergency Medicine Authors: Ken Davis, BA, EMT-P, FP-C Tags: Patient Care Cardiac & Resuscitation Source Type: news

Five Things Surgeons Need to Know About NOACs to Minimize Risks Five Things Surgeons Need to Know About NOACs to Minimize Risks
Non-vitamin K oral anticoagulants (NOACs) differ in important ways from warfarin, and surgeons need to appreciate these differences, researchers say.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 27, 2018 Category: Consumer Health News Tags: General Surgery News Source Type: news

Continuous Apixaban Safe During AF Ablation in At-Risk Patients Continuous Apixaban Safe During AF Ablation in At-Risk Patients
AXAFA-AFNEX 5 trial is the fourth to show similar safety with a novel oral anticoagulant vs warfarin, but some are disappointed with the new data.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 26, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

Apixaban is a safe alternative to warfarin during catheter ablation of atrial fibrillation
(European Society of Cardiology) Apixaban and warfarin are equally safe during catheter ablation of atrial fibrillation, according to results of the AXAFA-AFNET 5 trial presented today in a late-breaking trial session at EHRA 2018, a European Society of Cardiology (ESC) congress.1 There were similar rates of stroke and bleeding, and an improvement in cognitive function was shown for the first time. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 20, 2018 Category: International Medicine & Public Health Source Type: news

Evaluation of a protocol for early detection of delayed brain hemorrhage in head injured patients on warfarin - Huang JL, Woehrle TA, Conway P, McCarty CA, Eyer MM, Eyer SD.
PURPOSE: In 2007, Essentia Health St. Mary's Medical Center (SMMC), a Level II trauma center in northeastern Minnesota, implemented a protocol for patients who presented with blunt head trauma and were receiving warfarin for anticoagulation. The purpose of... (Source: SafetyLit)
Source: SafetyLit - March 19, 2018 Category: International Medicine & Public Health Tags: TBI Source Type: news

Head injury on Warfarin: likelihood of delayed intracranial bleeding in patients with negative initial head CT - Afaneh A, Ford J, Gharzeddine J, Mazar A, Hayward RD, Buck J.
OBJECTIVE: To determine the likelihood that head injured patients on Warfarin with a negative initial head CT will have a positive repeat head CT. A retrospective chart review of our institution's trauma registry was performed for all patients admitted for... (Source: SafetyLit)
Source: SafetyLit - March 19, 2018 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de la FDA de pacientes de Medicare encontr ó menor riesgo de derrame cerebral y muerte con Pradaxa (dabigatrán) en comparación con warfarina
[05-13-2014] En su estudio en curso del anticoagulante Pradaxa (dabigatr án), la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus sigla en inglés) completó recientemente un nuevo estudio en pacientes de Medicare en el que compara Pradaxa con un anticoagulante antiguo, warfarina (Coumadin, Jantoven y genéricos), para determinar el riesgo de a ccidente isquémico o derrame causado por un coágulo, hemorragia cerebral, hemorragia gastrointestinal severa, infarto de miocardio y muerte. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin
[05-13-2014] In its ongoing review of the blood thinner Pradaxa (dabigatran), the U.S. Food and Drug Administration (FDA) recently completed a new study in Medicare patients comparing Pradaxa to an older blood thinner, warfarin, for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

Complications of lower extremity hematomas in patients with pre-injury warfarine use - Bukovcan P, Koller J.
INTRODUCTION: The aim of this paper is to ascertain the number of patients with pre-injury warfarin use who developed lower extremity hematomas treated in our facility, to analyse the data, used treatment methods and outcomes in these patients. PAT... (Source: SafetyLit)
Source: SafetyLit - February 19, 2018 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Lower ICH Mortality Rate With NOACs Than Warfarin Lower ICH Mortality Rate With NOACs Than Warfarin
A large real-world study provides some reassurance about the consequences of suffering an intracerebral hemorrhage when taking one of the new oral anticoagulants.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 13, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news