Alertes Sanitaires

FDA: Patients With Mechanical Heart Valves Should Not Use Dabigatran

Date de publication sur le site SFMU : 22 décembre 2012

CBS News (12/21) reports on its website, "The US Food and Drug Administration warned that patients with mechanical heart valves should not use a blood thinner named Pradaxa [dabigatran]." The agency "said a clinical trail in Europe called RE-ALIGN was stopped because patients taking Pradaxa...were more likely to suffer from strokes, heart attacks and clots forming on their mechanical heart valves compared to those taking an older medication called warfarin."

MedPage Today (12/21, Kaiser) reports that "in its warning, the FDA noted that studies involving the use of dabigatran with bioprosthetic valves have not been conducted and so it cannot make any recommendation for or against its use. It urged physicians to evaluate patients on all types of prosthetic heart valves for the most appropriate medical therapy."

HealthDay (12/21, Preidt) reports, "Pradaxa is approved to treat patients with...atrial fibrillation. It is not approved to treat patients with atrial fibrillation caused by heart valve problems, the FDA said.

Heartwire (12/21, Nainggolan) reports, "Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of dabigatran to the FDA's MedWatch safety information and adverse-event reporting program."

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Partenaires institutionnels de l'Alerte Sanitaire d'Urgence du site S.F.M.U. :

Les institutions suivantes participent, soit contractuellement, soit par l'intermédiaire de correspondants, à l'évolution du site de la S.F.M.U. :

Direction Générale de la Santé, par l'intermédiaire du Docteur Philippe Magne, Bureau des Alertes et Problèmes Emergents. Site : Ministère de la Santé

Société de Toxicologie Clinique : Docteurs P. Manel, Docteur P. Harry

Anne-Sophie Barret pour l'Institut National de Veille Sanitaire

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