WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISKOF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
(A)
PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC
EVENTS
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 ].
(B) SPINAL/EPIDURAL HEMATOMA
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 ].
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PRADAXA SUMMARY
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.
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NEWS HIGHLIGHTS
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..
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
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 >>
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Page last updated: 2014-12-01
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