The European Medicines Agency has recommended updating the product information for Boehringer Ingelheim's new blockbuster bloodthinner Pradaxa concerning the risk of bleeding but has again stressed the benefits of the drug.
Noting that "bleeding is a well-known complication of all anticoagulant medicines", the EMA says Pradaxa (dabigatran) has been "kept under close review" by the agency’s Committee for Medicinal Products for Human Use (CHMP) since its initial authorisation in Europe back in March 2008 for the prevention of venous thromboembolic events following hip or knee replacement surgery.
However, the number of fatal bleeding cases has leapt since approval was expanded to cover patients with non-valvular atrial fibrillation to prevent stroke and systemic embolism. As such, the CHMP recommends updating the label following "the assessment of all available data, including from post-marketing surveillance, on Pradaxa and the risk of serious or fatal bleedings".
Importantly, the committee found that the frequency of occurrence of fatal bleedings with Pradaxa seen in post-marketing data "was significantly lower than what was observed in the clinical trials that supported the authorisation of the medicine". Nevertheless, it considered that this issue "should nonetheless be kept under close surveillance".
The CHMP concluded that the benefits of Pradaxa "continue to outweigh its risks and that it remains an important alternative to other blood-thinning agents [but] advice to doctors and patients should be updated and strengthened to give clearer guidance on the best use of the medicine".
This includes more specific guidance on when Pradaxa must not be used as well as advice on managing patients and reversing the anticoagulant effect of the drug if bleeding occurs.