Dabigatran Fatal Bleeding Less Than in Clinical Trials: New EMA Data

May 25, 2012

May 25, 2012 (London, United Kingdom) — The frequency of reported fatal bleeding with dabigatran (Pradaxa, Boehringer Ingelheim) since the drug has been approved has been significantly lower than that observed in clinical trials, according to new information from the European Medicines Agency (EMA).

In a new "in-depth" review of bleeding events with dabigatran since its approval, the EMA's Committee for Medicinal Products for Human Use (CHMP) nevertheless recommends that the risks continue to be kept under close review. Although it says the product information for dabigatran already contains appropriate measures to prevent and manage this risk of bleeding, it has decided that certain recommendations for prescribers and patients should be clarified and strengthened by adding further information.

The CHMP review was initiated in January, following reports of bleeding with dabigatran from around the world. The review considered the available data on the risk of serious or fatal bleeding with dabigatran, gathered since its approval, from both clinical trials and postmarketing surveillance. In a statement issued today, the EMA concludes that "the latest available data are consistent with the known risk of bleeding and that the risk profile of dabigatran is unchanged."

For prescribers, the update to the product information includes details on the specific situations where dabigatran must not be used (in patients with conditions putting them at significant risk of major bleeding) and a reminder of the need to assess kidney function before treatment in all patients and during treatment if a deterioration is suspected, as well as recommendations for dose reductions in certain patients. New warnings stressing that dabigatran must not be used in patients using any other anticoagulant, unless the patient is being switched to or from dabigatran, and the concomitant medications that put patients at significant risk of major bleeding have also been added.

The information also includes details on how kidney function should be assessed and options for managing patients and reversing the anticoagulant effect of dabigatran if bleeding occurs.

In addition, the CHMP noted that reports of bleeding with dabigatran often involved the patient having an accident or injury, so it has decided that advice should be included in the package leaflet for patients to seek urgent medical attention if they fall or injure themselves during treatment.

A European Commission decision on this opinion will be issued in due course.

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