FDA Launches Pradaxa Bleeding Risk Assessment

January 14, 2014 — Pradaxa (dabigatran) is a controversial new blood-thinning medication that has no antidote, which many experts are concerned could increase a user’s risk of severe bleeding in an emergency.

Since it was introduced in 2010, Pradaxa has been associated with over 500 deaths in the United States alone. Now, the U.S. Food and Drug Administration (FDA) is launching a new safety assessment of bleeding from Pradaxa versus warfarin.

The FDA will use data from the Mini Sentinel Pilot Project project, which includes healthcare data on nearly 100 million patients.

According to Forbes, the purpose of the study is to identify patients who are at high risk for major bleeding events from Pradaxa. Some studies have already found higher risks for older women.

However, one issue with the study is that it only investigates the rate of gastrointestinal and intracranial bleeding in patients on either Pradaxa and warfarin. It does not investigate the outcome. While warfarin can be reversed with a dose of Vitamin K, Pradaxa has no antidote, which could affect patient outcomes.

According to a recent report by the Institute for Safe Medicine Practices (ISMP), bleeding incidents from Pradaxa “were about 5 times more likely than warfarin to result in death (19% versus 4%).”

Even so, Boehringer Ingelheim continues to defend the safety of Pradaxa, stating:

“Previous assessments from the Mini-Sentinel pilot, which were published in November 2012 and April 2013, found that bleeding rates associated with new use of Pradaxa do not appear to be higher than those with new use of warfarin…”

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