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Pradaxa (Dabigatran Etexilate Mesylate) - Summary



Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.4, 2.5, 2.6) and Warnings and Precautions ].

Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

 • use of indwelling epidural catheters
 • concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
 • a history of traumatic or repeated epidural or spinal punctures
 • a history of spinal deformity or spinal surgery
 • optimal timing between the administration of PRADAXA and neuraxial procedures is not known [see Warnings and Precautions ].

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions ].

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions ].



The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor.

PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

See all Pradaxa indications & dosage >>


Published Studies Related to Pradaxa (Dabigatran)

The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. [2013]
CONCLUSIONS: During 2.3 years of continued treatment with dabigatran after RE-LY,

Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial. [2011]
CONCLUSIONS: Dabigatran, in addition to dual antiplatelet therapy, was associated

Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. [2010]
ischaemic attack... INTERPRETATION: The effects of 110 mg dabigatran and 150 mg dabigatran twice

Dabigatran versus enoxaparin for prevention of venous thromboembolism after hip or knee arthroplasty: a pooled analysis of three trials. [2010]
CONCLUSIONS: Oral dabigatran was as effective as subcutaneous enoxaparin in

Insights from the dabigatran versus warfarin trial in patients with venous thromboembolism (the RE-COVER trial). [2010]
In this clinical trial evaluation, we revisit the RE-COVER study, a large multicenter, randomized, double-blind, noninferiority trial on patients with acute venous thromboembolism treated with dabigatran versus warfarin. Study design and key results are re-evaluated in the context of previous work and future perspectives..

more studies >>

Clinical Trials Related to Pradaxa (Dabigatran)

A Prospective, Open Label Study Evaluating Two Management Strategies on Gastrointestinal Symptoms in Patients Newly on Treatment With Pradaxa for the Prevention of Stroke and Systemic Embolism With Non-valvular Atrial Fibrillation [Completed]
This is a prospective and open label study that aims to enroll approximately 1200 patients with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa and free of gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately 125 sites in North America will be recruited. Patients who report GIS during the 3 month treatment period will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected.

Relative Bioavailability of Single Doses of Dabigatran Etexilate in Healthy Volunteers [Completed]
Study to investigate whether and to what extent the suggested P-glycoprotein (P-gp) inducer rifampicin affects plasma exposure of dabigatran.

Safety & Suitability of Dabigatran to Inhibit Thrombin in Scleroderma [Not yet recruiting]
This study evaluates if dabigatran etexilate is safe for use in patients with Scleroderma and Interstitial Lung Disease. All patients will receive 75mg of dabigatran etexilate twice a day for 6 months.

Investigation Drug-drug Interaction Between Dabigatran and Clarithromycin [Completed]
Dabigatran (Pradaxa ) is a new oral anticoagulant. It is used to prevent venous thromboembolism in orthopedic surgery and has recently demonstrated efficacy and safety at least as good as anticoagulants in the prevention of thromboembolism in atrial fibrillation and the treatment of venous thromboembolism. It is administered with fixed dose and does not require laboratory monitoring because of the low inter and intra individual pharmacokinetic (PK) and pharmacodynamics (PD) of dabigatran. However, the bioavailability of dabigatran is very low (6. 5%) and is controlled by an efflux protein, P-GP. This molecule has a genetic polymorphism. The inhibition of this protein can cause a significant increase in intestinal absorption of dabigatran and expose patients to a risk of bleeding by overdose. Two major drug interactions have been identified : quinidine (cons-indication) and amiodarone (precautions). It is likely that other interactions exist and can be clinically significant in patients not selected such as testing. The development of tools to study the influence of P-GP on the PK and PD of dabigatran is therefore interesting. As the P-GP has a genetic polymorphism, the study of the latter is an important element in the detection of drug interactions. In this sense, clarithromycin, a potent inhibitor of P-GP is a good model to evaluate the primary mechanism of drug interaction of dabigatran and optimize the experimental design of studies to be conducted.

Bioavailability of BIBR 953 ZW After Oral Administration of BIBR 1048 MS in Healthy Subjects [Completed]
Study to assess the amount of BIBR 953 ZW in urine after administration of 50 mg BIBR 1048 bid over three days each administered as four experimental formulations relative to drinking solution with and without coadministration of 40 mg Pantoprazole

more trials >>

Reports of Suspected Pradaxa (Dabigatran) Side Effects

Gastrointestinal Haemorrhage (1284)Cerebrovascular Accident (702)Haemorrhage (638)Death (535)Fall (391)Dyspepsia (366)Rectal Haemorrhage (351)Dizziness (326)Melaena (321)Anaemia (286)more >>

Page last updated: 2014-12-01

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