FDA Investigates Serious Bleeding Events with Pradaxa

The Food and Drug Administration (FDA) announced on December 7th that it will be evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa, Boehringer Ingelheim (dabigatran).

Pradaxa is an anticoagulant (blood thinner) known as a direct thrombin inhibitor. It is approved to reduce the risk of stroke and embolism (blood clots) in patients with non-valvular atrial fibrillation. Having a stroke can cause permanent disability and death.  You should also know that while taking Pradaxa, you may bruise more easily and it may take longer for any bleeding to stop.  Dabigatran is eliminated by the kidneys, so renal function should be assessed before and during treatment to determine proper dosage.

The “FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa,” according to the safety communication issued by the agency.

Bleeding events with dabigatran have already prompted safety advisories in Japan and Australia, and have led to labeling updates in Europe and the US focusing on the need for monitoring renal (kidney) function. In November, Boehringer Ingelheim confirmed that between March 2008 and October 31, 2011, there were 260 fatal bleeding events worldwide.

Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. There is a label containing warnings about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

Although the FDA promises to inform the public and clinicians when new information about bleeding risks becomes available, the agency states that they believe the anticoagulant provides an important health benefit when used as directed and that patients should not discontinue use without talking to their doctor.

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