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EMA clears Boehringer's Pradaxa despite patient deaths

Regulator won't add further restrictions to use of the anticoagulant

European regulators will not add further restrictions to the use of Boehringer Ingelheim's Pradaxa (dabigatran etexilate), despite the drug being associated with more than 250 patient deaths.

The European Medicines Agency (EMA) said the risk of bleeding with anticoagulant medicines was well known and the reports had to be seen in context.

The EMA recorded 256 reports worldwide of serious bleeding resulting in death for patients taking Pradaxa by November 6, 2011, with 21 of the cases occurring in the EU.

The EMA said awareness of the drug has been increasing, as it is being used more widely, and that this was a factor known to lead to higher than usual reporting of side effects.

Nevertheless, the regulator said the issue has been “kept under close review” and EMA advisors at the Committee for Medicinal Products for Human Use (CHMP) recommended in October adding further safety measures to Pradaxa's use.

These included assessing renal function in all patients before starting treatment and assessing renal function at least once a year in patients over 75 years of age while on treatment.

The CHMP said its changes to the use of Pradaxa would be enough to adequately manage the risk of bleeding, but that it would also look again at all case reports received so far to confirm that the frequency of occurrence of fatal bleedings has not increased and that the recommended product information is appropriate to manage the risk.

Pradaxa prescribing was boosted in August when it won a new indication in several regions, including the EU, to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation.

The anticoagulant was first licensed in March 2008 for the primary prevention of venous thromboembolic events in adults who have had elective total hip replacement surgery or total knee replacement surgery.

Since then the drug's license has recommended doctors check for signs of bleeding and discontinue treatment in patients with severe bleeding. Pradaxa is also contraindicated in a number of conditions, including in patients who are bleeding and patients with severe renal impairment.

It should also be used with caution and at lower doses in elderly patients and patients with moderate renal impairment.

The EMA said it would continue to closely monitor this issue and the overall safety profile of Pradaxa.

21st November 2011

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