News
Stroke, Major Bleed Risk Compared Among Novel Oral Anticoagulants
The study analyzed data from NVAF patients newly initiating treatment with dabigatran, rivaroxaban or apixaban.
Your search for dabigatran returned 7 results
Drugs in the Pipeline
Pradaxa Under Review for DVT and PE
The FDA has accepted for review the sNDA for Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE).
News
GI Bleed Hospitalization Risk Linked to Oral Anticoagulant Choice, PPI Cotherapy
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.
Safety Alerts and Recalls, Uncategorized
Single Lot of Pradaxa 75mg Recalled
Boehringer Ingelheim announced that it is conducting a nationwide recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate) capsules 75mg.
Drugs in the Pipeline
FDA Accepts sNDA for New Pradaxa Indication
Boehringer Ingelheim announced that the FDA has accepted for filing the supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery.
Uncategorized
SAFETY ALERT: FDA Evaluating Risk of Serious Bleeding Events with Pradaxa
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).
Uncategorized
FDA: Pradaxa vs. Warfarin Study Results Announced
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.
