Study Finds Boehringer Withheld Pradaxa Safety InformationJuly 23, 2014 — Boehringer Ingelheim knew that blood tests and routine monitoring could improve the safety of Pradaxa (dabigatran), but failed to share those findings with health officials, according to a series of reports published in the British Medical Journal.

BMJ investigations editor Dr. Deborah Cohen says Boehringer produced “extensive analyses” showing that major bleeding from Pradaxa could be reduced by 30-40% with routine monitoring and lower starting doses. However, this information was not disclosed to regulators, doctors, or patients.

According to Dr. Cohen:

“[Boehringer] failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible. The company also withheld analyses that calculated how many major bleeds dose adjustment could prevent.”

Instead of sharing risk information with doctors, patients, and regulators, Boehringer marketed Pradaxa as an easier alternative to warfarin. Unlike warfarin, which requires routine blood tests to adjust dosage, Pradaxa is a once-daily or twice-daily pill.

Pradaxa may be easier to use than warfarin, but there are serious safety concerns. Citing federal statistics, the BMJ warned that Pradaxa was linked to 542 deaths and nearly 2,400 hemorrhages in 2011. In comparison, warfarin was linked to just 72 deaths in 2011.

An accompanying editorial also raised serious doubts about Pradaxa, noting the drugs “fickle pharmacokinetics, which can cause a five-fold variation of plasma concentration.” The experts were also concerned about unreliable data and problems with “design and oversight” of the RE-LY clinical trial, the cornerstone safety study for Pradaxa.

These conclusions were partly based on data gleaned from documents produced in litigation. In May, Boehringer agreed to pay $650 million to settle up to 4,000 lawsuits pending in federal court in Illinois.

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