New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO ® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events

RARITAN, NJ, September 27, 2021 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today new data from the Phase 3 UNIVERSE study showing treatment with XARELTO® (rivaroxaban) in an oral suspension formulation, compared to treatment with aspirin, was associated with numerically fewer blood clots and clinical events strongly associated with blood clots in pediatric patients (aged 2-8 years) who have undergone the Fontan procedure. [1] These findings, which were published this month in the Journal of the American Heart Association and included in a recent New Drug Application submitted to the U.S. Food and Drug Administration, also found treatment with XARELTO® was associated with a similar safety profile compared to aspirin.The Fontan procedure is performed in children with congenital heart disease who have a single functioning ventricle to redirect blood flow to the lungs to be reoxygenated. Children who undergo the Fontan procedure often face significant morbidity and mortality stemming from thrombotic events, especially during the critical 3- to 12-month period following the procedure. While it is common for physicians to prescribe aspirin, there are limited data regarding aspirin resistance or the optimal dose for thromboprophylaxis in children. “For years, health care providers have had limited options to help reduce potentially fatal thrombotic events that often occur in young children following the Fontan procedure,” saidB...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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A change to the policy announced in September makes vaccination at Highmark Health, Highmark Inc. and Allegheny Health Network a condition of employment.
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Source: Guardian Unlimited Science - Category: Science Authors: Tags: Victoria Medical research Health Australia news Coronavirus Source Type: news
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Source: Medscape Internal Medicine Headlines - Category: Internal Medicine Tags: Infectious Diseases News Source Type: news
A change to the policy announced in September makes vaccination at Highmark Health, Highmark Inc. and Allegheny Health Network a condition of employment.
Source: Health Care News Headlines - Category: Health Management Authors: Source Type: news
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Source: Surgery Today - Category: Surgery Source Type: research
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Source: Surgery Today - Category: Surgery Source Type: research
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Source: Surgery Today - Category: Surgery Source Type: research
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Source: Surgery Today - Category: Surgery Source Type: research
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Source: Surgery Today - Category: Surgery Source Type: research
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Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Critical Care Source Type: forums
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