EMA updates Pradaxa label: Bleeds not as bad as in trial

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The European Medicines Agency (EMA) has recommended updating product information for the anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) to provide clearer guidance to doctors and patients on how to reduce and manage the risk of bleeding associated with the medicine in patients with atrial fibrillation (AF).

The EMA's Committee for Medicinal Products for Human Use made the recommendation May 25 after assessing data that included post-marketing surveillance on the drug’s risk of serious or fatal bleedings. The committee concluded that the frequency of occurrence of fatal bleedings with dabigatran in post-marketing data was significantly lower than what was observed in the clinical trials used for approval of the drug and the benefits continue to outweigh its risks.

Nonetheless, the committee determined that more specific guidance was warranted on when dabigatran is contraindicated and on how to reverse its anticoagulant effect if bleeding occurs.

The EMA approved dabigatran in 2011 for preventing stroke and systemic embolism in non-valvular AF patients as an alternative to warfarin. Later that year the agency updated its safety label after several cases of fatal bleeding events were reported.  At that time the agency said the number of increased bleeds may stem from the increased use of the drug.

According to the EMA, the European Commission will issue a decision on the recommendation “in due course.”