Janssen Submits New Drug Application to U.S. FDA for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with congenita...
Source: Johnson and Johnson - June 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
No Benefit to Postop Heparin Bridging in Patients Who Stop Warfarin for a Procedure No Benefit to Postop Heparin Bridging in Patients Who Stop Warfarin for a Procedure
There does not appear to be a benefit to postoperative heparin bridging in patients with atrial fibrillation or a mechanical heart valve who temporarily stop taking warfarin before a planned procedure, according to results of the PERIOP2 study.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - June 18, 2021 Category: Surgery Tags: Cardiology News Source Type: news
Late-Breaking Data at ACC.21 Show XARELTO ® (rivaroxaban) Plus Aspirin Significantly Reduced Total Ischemic Events in Peripheral Artery Disease (PAD) Patients After Lower-Extremity Revascularization
RARITAN, N.J., May 16, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today presented new data from the Phase 3 VOYAGER PAD study which showed XARELTO® (rivaroxaban) (2.5 mg twice daily) in combination with aspirin (100 mg once daily) consistently reduced severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER) compared to aspirin alone regardless of whether it was the first, second, third, or subsequent event. The primary results of VOYAGER PAD showed that XARELTO® plus aspirin reduced first events by 15 percent among patients with PAD ...
Source: Johnson and Johnson - May 16, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Effectiveness of Anticoagulants Compared for Valvular A-Fib
TUESDAY, March 30, 2021 -- For patients who are new to therapy for valvular atrial fibrillation (AF), direct oral anticoagulants (DOACs) as a class are effective and safe compared with warfarin, with some variability among individual DOACs,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 30, 2021 Category: Pharmaceuticals Source Type: news
Unexpected severe intra-abdominal injuries resulting from a ground-level fall in an elderly patient with a large staghorn calculus - Lightfoot A, Chan J.
A 70-year-old woman on warfarin was transported to the emergency department after a ground-level fall, injuring her left backside. Criteria for geriatric trauma activation was not met. An episode of haematuria created suspicion for an intra-abdominal injur... (Source: SafetyLit)
Source: SafetyLit - March 25, 2021 Category: International Medicine & Public Health Tags: Age: Elder Adults Source Type: news
Aspirin preferred to prevent blood clots in kids after heart surgery
(Murdoch Childrens Research Institute) Aspirin should be favoured over warfarin to prevent blood clotting in children who undergo a surgery that replumbs their hearts, according to a new study. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 14, 2021 Category: International Medicine & Public Health Source Type: news
The effect of Covid-19 related lockdown on patients taking warfarin, Nottingham University Hospitals NHS Trust
This service improvement study looked at time periods pre-COVID-19, pre lockdown, lockdown and post lockdown, and noted time in therapeutic range during lockdown dropped. These data were used by service so that it was better prepared to manage patients during subsequent lockdown. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - January 6, 2021 Category: Consumer Health News Source Type: news
Comunicado de la FDA sobre la seguridad de los medicamentos: Actualizaci ón sobre el riesgo de eventos severos de hemorragia con el anticoagulante Pradaxa (dabigatrán etexilato mesilato)
[5 de noviembre del 2012. La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA pos sus siglas en inglés) ha evaluado nueva información sobre hemorragias severas con el uso de los anticoagulantes dabigatrán (Pradaxa) y warfarina (Coumadin, Jantoven y medicamentos genéricos). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 4, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news
ACR: Warfarin Tied to Increased Risk for Knee, Hip Replacement in OA
MONDAY, Nov. 16, 2020 -- For adults with atrial fibrillation, warfarin is associated with an increased risk for knee and hip replacements for osteoarthritis (OA), according to a study presented at ACR Convergence, the annual meeting of the American... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 16, 2020 Category: Pharmaceuticals Source Type: news
RIVER: Rivaroxaban Rivals Warfarin in AF, Mitral Bioprosthesis RIVER: Rivaroxaban Rivals Warfarin in AF, Mitral Bioprosthesis
The trial from Brazil may not be easily extrapolated to other regions, but it starts to fill a largely vacant evidence base for patients not well represented in major trials of nonvalvular AF DOACs.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - November 15, 2020 Category: Cardiology Tags: Cardiology News Source Type: news
New XARELTO ® (rivaroxaban) Peripheral Artery Disease (PAD) Data from EXPLORER Clinical Research Program to be Unveiled at American Heart Association (AHA) Scientific Sessions 2020
RARITAN, N.J., November 9, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that 10 data presentations will be shared at the virtual American Heart Association (AHA) Scientific Sessions 2020 from November 13-17. Most notably, four new sub-analyses of XARELTO® (rivaroxaban) from the landmark VOYAGER PAD trial, part of the EXPLORER global cardiovascular research program, will be presented, including two live, featured science oral presentations. “We're pleased VOYAGER PAD was selected to be front and center once again at a major medical congress, as there's an urgent need for data in ...
Source: Johnson and Johnson - November 9, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Warfarin Use Linked to Knee and Hip Replacement in OA Patients Warfarin Use Linked to Knee and Hip Replacement in OA Patients
Patients who take vitamin K antagonist warfarin to prevent thromboembolic events are significantly more likely to require knee or hip replacement surgery than those who take direct oral anticoagulants.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - November 9, 2020 Category: Cardiology Tags: Rheumatology News Source Type: news
Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revascularization, a c...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Warfarin and other anticoagulants: monitoring of patients during the COVID-19 pandemic, MHRA
The MHRA has issued advice to healthcare professionals and patients regarding the safe use of warfarin and other anticoagulants, following concerns over an apparent increase in the number of patients taking warfarin found to have an elevated INR during the COVID-19 pandemic. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - October 26, 2020 Category: Consumer Health News Source Type: news
COVID-19 rapid guideline: managing symptoms (including at the end of life) in the community [NG163], NICE (updated 13th October 2020)
MHRA advice on warfarin and other anticoagulants: In October 2020, we amended recommendations on taking into account a patient ' s existing medicines to link to 2 External 0 0 0 MHRA advice on warfarin and other anticoagulants – monitoring of patients during the COVID-19 pandemic false https://www.gov.uk/government/publications/warfarin-and-other-anticoagulants-monitoring-of-patients-during-the-covid-19-pandemic true false%>, which includes reports of supratherapeutic anticoagulation with warfarin.
This guideline focuses on what you need to stop or start doing during the pandemic. Follow the usual professional guideli...
Source: Current Awareness Service for Health (CASH) - October 15, 2020 Category: Consumer Health News Source Type: news
