Pradaxa Linked to More Bleeding Than Reported to FDA

May 27, 2014 — Boehringer Ingelheim has admitted that 22 cases of serious bleeding were not included in the RE-LY clinical trial, the pivotal safety study that compared Pradaxa (dabigatran) to warfarin. The FDA used results of the 18,000-patient study to approve Pradaxa in 2010.

According to Bloomberg, five more complications were seen in patients on 110-mg doses of Pradaxa, 11 more complications occurred in patients on 150-mg doses, and warfarin was associated with six additional complications.

In November 2010, Boehringer Ingelheim issued another correction to the RE-LY study after finding 81 major complications in 80 patients, including blood cots, serious bleeding, one stroke, and four heart attacks.

Researchers say the additional adverse events do not change the conclusions of the study. The results are similar to results of a study published earlier this month of 134,000 Medicare patients over the age of 65 who took either Pradaxa or warfarin. The FDA warned that Pradaxa had lower rates of stroke and death compared to warfarin, but higher rates of gastrointestinal bleeding.

Despite reassurances from the FDA and Boehringer Ingelheim, many experts remain concerned about the bleeding risks of Pradaxa. Unlike warfarin, which can be reversed with a dose of Vitamin K, Pradaxa has no effective reversal-agent. In an emergency, it may be difficult or impossible to stop its blood-thinning effects.

Boehringer Ingelheim currently faces more than 2,000 lawsuits filed on behalf of people throughout the United States who allege that the drug-maker failed to warn about the risks of the drug. The cases are centralized in federal court in Illinois, with the first “bellwether” trials set to go before a jury between September 2014 and March 2015.

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