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Pradaxa Bleeding Risk Analysis Hidden from FDA

Pradaxa Bleeding Risk Analysis Hidden from FDA

February 26, 2014 — Documents unsealed in an ongoing lawsuit reveal that Boehringer Ingelheim concealed an analysis linking Pradaxa (dabigatran) to a higher rate of fatal bleeding than expected, according to Bloomberg News.

Boehringer provided the FDA with an analysis showing 6.1 deaths from bleeding per 10,000 patients on Pradaxa after the drug was approved in October 2010.

But when the FDA asked Boehringer to re-analyze data from clinical trials before Pradaxa was approved, the company produced two analyses. Boehringer provided the FDA with one analysis showing 5.8 deaths from bleeding per 10,000 patients. However, they decided not to disclose another analysis showing that 19.5 people in 10,000 had a major bleeding event and died for any reason.

Boehringer is currently facing over 2,000 lawsuits involving Pradaxa. The litigation is centralized in federal court in Illinois before Judge David R. Herndon, Multi-District Litigation (MDL No. 2385).

Plaintiffs allege that Boehringer failed to adequately warn the FDA, doctors, and patients about the risk of bleeding from Pradaxa. Unlike the blood-thinner warfarin, which is counteracted with a dose of Vitamin K, Pradaxa has no antidote and its blood-thinning effects are not easily reversed in a bleeding emergency.

Do I have a Pradaxa Lawsuit?

The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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