[12][13] Dabigatran is used to prevent strokes in those with atrial fibrillation not caused by heart valve issues, as well as deep vein thrombosis and pulmonary embolism in persons who have been treated for 5–10 days with parenteral anticoagulant (usually low molecular weight heparin), and to prevent deep vein thrombosis and pulmonary embolism in some circumstances.
[4] It appears to be as effective as warfarin in preventing non-hemorrhagic strokes and embolic events in those with atrial fibrillation not due to valve problems.
RE-ALIGN was terminated early because the Pradaxa treatment group had significantly more thromboembolic events and major bleeding than warfarin and determined to be contraindicated for use in patients with mechanical heart valves.
[23] A small but significantly increased risk of myocardial infarctions (heart attacks) has been noted when combining the safety outcome data from multiple trials.
[26] For patients with moderately reduced kidney function, lower dabigatran doses are recommended due to increased drug exposure and bleeding risk.
[31] Additionally, patients with limited mobility, reduced salivary secretion, and low water consumption will increase the possibility of contact by dabigatran with the esophageal mucosa.
[23] The Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial showed that impairment of liver function caused by dabigatran occurred in the same frequency as warfarin.
[4] Several studies have demonstrated that dabigatran plasma concentrations are reduced when co-administered with proton pump inhibitors, however it is unclear if this reduction is clinically significant.
Addition of ethyl ester and hexyloxycarbonyl carbamide hydrophobic side chains led to the orally absorbed prodrug, BIBR 1048 (dabigatran etexilate).
[39] In March 2008, the European Medicines Agency (EMA) granted marketing authorization for Pradaxa for the prevention of thromboembolic disease following hip or knee replacement surgery and for non-valvular atrial fibrillation.
[40] The National Health Service (NHS) in Britain authorized dabigatran for use in preventing blood clots in hip and knee replacement surgery patients.
[46][47] The U.S. Food and Drug Administration (FDA) approved Pradaxa in October 2010, for prevention of stroke in patients with non-valvular atrial fibrillation.
[55] In July 2014, a series of investigations accused the privately held Boehringer Ingelheim pharmaceutical group of withholding critical information about the need for monitoring to protect patients from severe bleeding, particularly in the elderly.
The BMJ investigation suggested that Boehringer had a financial motive to withhold this concern from regulatory health agencies because the data conflicted with their extensive marketing of dabigatran as an anticoagulant that does not require monitoring.
[56][57] In August 2012, Pradaxa claims filed in U.S. federal courts were consolidated into a multi-district litigation in the Southern District of Illinois before Chief Judge David R. Herndon.