Uncategorized
The FDA announced the results of a new study on Medicare patients comparing Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim Pharmaceuticals) vs. warfarin for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death.
News
For veterans receiving warfarin for nonvalvular atrial fibrillation, continuing warfarin after a diagnosis of dementia is associated with a protective effect in prevention of stroke and mortality, according to a study published online December 30 in the Journal of the American Geriatrics Society.
News
A retrospective cohort study in the Annals of Pharmacotherapy found a clinically significant decrease in warfarin dose-response with concurrent hepatitis C treatments, especially with ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV-PTV/r-DSV).
Drugs in the Pipeline
CSL Behring announced results of a Phase 3b study that showed that a balanced, human 4-factor prothrombin complex concentrate (PCC) is as effective as the current standard of treatment in stopping bleeding in patients receiving vitamin K antagonist therapy (eg, warfarin).
Drugs in the Pipeline
CSL Behring announced that the FDA has accepted for standard review its Biologics License Application (BLA) for a human 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of vitamin K-antagonist therapy (eg, warfarin) in patients with acute major bleeding.
News
Patients with atrial fibrillation taking long-term warfarin had higher rates of dementia than non-atrial fibrillation patients, a study presented at the Heart Rhythm Society's 37th Annual Scientific Sessions has found.
News
The FDA has approved the expanded indication for Kcentra (Prothrombin Complex Concentrate [Human]; CSL Behring) to include the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in adult patients needing an urgent surgery or other invasive procedure.
News
Bristol-Myers Squibb and Pfizer announced that the FDA has approved Eliquis (apixaban tablets) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).
News
To compare the incidence of hospitalization for upper GI tract bleeding, researchers used US Medicare beneficiary files to identify a cohort of patients that were ≥30 years old who initiated oral anticoagulation therapy with apixaban, dabigatran, rivaroxaban, or warfarin, with or without PPI cotherapy.
Uncategorized
The FDA has notified healthcare professionals that it is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim).
