Use Of Pradaxa After ACS Is Associated With Increased Rate Of Major Bleeding, And Concomitant Use Of Pradaxa With Multaq Is Contraindicated

(Posted by Tom Lamb at DrugInjuryWatch.com)

When Pradaxa (dabigatran) is used to prevent thrombotic events after an acute coronary syndrome (ACS), it is associated with increased rates of major bleeding that offsets any antithrombotic benefit, according to a September 24, 2012 (Online First) Archives of Internal Medicine article, "Use of New-Generation Oral Anticoagulant Agents in Patients Receiving Antiplatelet Therapy After an Acute Coronary Syndrome".

From the Abstract for this medical journal article:

Results  For the period January 1, 2000, through December 31, 2011, we identified 7 prospective randomized placebo-controlled clinical trials that met the study criteria, involving 31 286 patients. Based on the pooled results, the use of new-generation oral anticoagulant agents [i.e., Pradaxa as well as Xarelto (rivaroxaba) and the not yet FDA-approved Eliquis (apixaban)] in patients receiving antiplatelet therapy after an ACS was associated with a dramatic increase in major bleeding events (odds ratio, 3.03; 95% CI, 2.20-4.16; P < .001)….

Conclusion  The use of [Pradaxa as well as Xarelto and Eliquis] is associated with a dramatic increase in major bleeding events, which might offset all ischemic benefits in patients receiving antiplatelet therapy after an ACS.

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Next, on September 20, 2012 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a new contraindication for the Multaq, "Co-administration with dabigatran" — or the concomitant use of Multaq and Pradaxa — which concerns the safety of both of these alleged unsafe drugs.

We will continue to watch for safety issues involving Pradaxa and significant developments here.

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