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FDA will Assess Safety of Anticoagulant Drug, Pradaxa

Filed January 8th, 2014 Laurie

There has been widespread concern over the safety of Pradaxa (dabigatran), Boehringer Ingelheim’s anticoagulant drug, ever since the medication was approved in Europe in 2008 and in the U.S. in 2010. In response to these fears, the U.S. Food and Drug Administration (FDA) announced that the agency would perform a large new assessment of Pradaxa compared to warfarin.

On December 30, the FDA posted a request for public comment on a proposed protocol of the study on the agency website, described as “a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin.” The study will be designed to “assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of dabigatran and warfarin for patients with atrial fibrillation using data from the FDA Mini-Sentinel Distributed Database (MSDD),” according to

The study is a Mini-Sentinel project, a part of the FDA’s Sentinal active surveillance system. The Mini-Sentinel, which is not so “mini” – it includes 17 data partners and uses data from nearly 100 million patients – uses pre-existing electronic healthcare data from multiple sources, reported.

A knowledgeable source told that the primary purpose of the study will be to identify groups of patients who are at high risk for bleeding events with Pradaxa.

In a statement obtained by, Boehringer Ingelheim was quick to defend the company’s product, saying, “It is important to note that the protocol currently posted on the Mini-Sentinel site states that the fact that FDA requests and receives data on a particular product through Mini-Sentinel does not necessarily mean there is a safety issue with the product.”

Pradaxa has been responsible for more than 500 deaths in the U.S. alone. Many lawsuits have been filed on behalf of patients allegedly injured by the drug.

While warfarin is notoriously difficult to dose, requires ongoing monitoring, and carries its own bleeding risks, (the drug ranked No. 2 last year for adverse events) there is an antidote to warfarin bleeding. wrote that there is no antidote to bleeding, either, for Pradaxa or any of the newer anticoagulant drugs on the market, however.

The FDA will only study the bleeding risks associated with Pradaxa. At this time, the agency has no plans to assess the safety of more recently approved anticoagulant drugs, like Johnson & Johnson’s Xarelto, or Bristol-Myers Squibb’s and Pfizer’s Eliquis. Concerns over the safety of Pradaxa are likely to be reinforced by the agency’s unwillingness to study the newer anticoagulant drugs, according to

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