Dabigatran Bleeding Analysis Not Disclosed to FDA, Documents Show

Shelley Wood

February 26, 2014

INGELHEIM, GERMANY — The drug maker that brought the first novel oral anticoagulant to market in the US failed to provide regulators with an analysis showing that dabigatran (Pradaxa) may have caused more fatal bleeding once approved for sale than it did in the RE-LY trial that supported the drug's approval, Bloomberg News reports[1].

Reporters Jef Feeley and Michelle Fay Cortez write that, according to documents unsealed as part of court proceedings, Boehringer gave the FDA one analysis following the 2010 approval of the drug, showing that fatal bleeds postapproval were less than in RE-LY. But according to the internal documents now made public, the company did not share a second analysis that had a lower number of fatal bleeds in the actual RE-LY trial, putting the postapproval bleeding rates higher than what was seen in the pivotal trial.

News of the second analysis has emerged as part of court filings related to more than 2000 lawsuits Boehringer is facing in the US, claiming dabigatran caused severe and fatal bleeding.

Bloomberg quotes company spokesperson Marjorie Moeling as saying that Boehringer provided the agency with what the company believed was the most appropriate analysis, adding, "The company is completely confident that all of the facts will show that Boehringer Ingelheim acted appropriately and responsibly."

The Bloomberg article quotes Dr Harlan Krumholz (Yale University School of Medicine, New Haven, CT), who is not involved in the Pradaxa lawsuits but is a staunch advocate for data transparency. "It is important to resist selective presentation of results, especially when the finding depends on which analysis is done," Krumholz said. "The fact that different analyses of the same data can yield different conclusions makes it imperative that we promote an opportunity for independent analyses through data sharing so that these issues will be out in the open."

Last month, the New York Times reported that the same unsealed court documents show that Boehringer employees were worried about publishing a research paper suggesting that patients taking dabigatran might require blood monitoring.

The FDA is planning a study to assess safety outcomes in adults with atrial fibrillation (AF) who recently started taking dabigatran or warfarin, as reported by heartwire . A period of public comment on that study closed last month. Separately, the FDA's Mini-Sentinel Operations Center announced it was developing a prospective surveillance plan for dabigatran competitor rivaroxaban (Xarelto, Bayer Pharma/Janssen Pharmaceuticals), tracking safety outcomes in adults with AF who are new users of this agent, compared with warfarin.

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