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New Pradaxa Bleeding Side Effect Guidance Recommended in Europe

May 25, 2012 | Parker Waichman LLP

European regulators have completed another Pradaxa review, and are recommending that the blood thinner’s label be updated with new safety information regarding Pradaxa bleeding side effects.  The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) said the Pradaxa label should include new guidance as to when the blood thinner should not be used.  The Committee also wants Boehringer Ingelheim to include advice on managing patients and reversing Pradaxa's blood thinning effect if bleeding occurs.

In November, CHMP asked that Boehringer Ingelheim include more label information on Pradaxa bleeding side effects. The Committee also advised that Pradaxa should be used with caution, and at lower doses in the elderly and kidney patients.  At the time, around 250 Pradaxa bleeding deaths had been reported to Boehringer Ingelheim.

Recently, European regulators expanded Pradaxa's approved uses to include patients with non-valvular atrial fibrillation to prevent stroke and systemic embolism.  According to a report from Pharma Times, the number of fatal bleeding events among Pradaxa users spiked following that expansion. 

In a statement issued today by the CHMP, patients taking Pradaxa were advised to be aware that they are at an increased risk of bleeding. If they fall or injure themselves during treatment, especially if they hit their head, they should seek urgent medical attention.

Prescribers were reminded of the need to follow all the necessary precautions with regard to the risk Pradaxa bleeding including the assessment of kidney function before treatment in all patients and during treatment if a deterioration is suspected, as well as dose reductions in certain patients. Pradaxa must not be used in patients with a lesion or condition putting them at significant risk of major bleeding, the Committee said.

Pradaxa was the first of a new class of blood thinners called direct thrombin inhibitor that are being touted as safer alternatives to warfarin.  However, while severe bleeding side effects from warfarin can be stopped via the administration of vitamin K, there is no readily available antidote to Pradaxa bleeding.

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