May 27, 2014 — Boehringer Ingelheim, the manufacturer of Pradaxa (dabigatran), has reported an additional 22 cases of serious bleeding that were not included in the original safety study the FDA used to approve Pradaxa in 2010.
The RE-LY clinical trial, published in the New England Journal of Medicine in 2009, concluded that Pradaxa was equally effective at preventing blood clots and stroke as warfarin. Conclusions were based on data from over 18,000 people.
This is not the first time Boehringer has added adverse events to the RE-LY trial, according to Bloomberg. In November 2010, they added 81 adverse events in 80 patients, including side effects like blood cots, serious bleeding, one stroke, and four heart attacks.
The latest update includes 6 bleeding events that occurred in patients on 110-mg doses of Pradaxa, 11 events in patients on 150-mg doses, and 6 events in patients on warfarin.
Researchers concluded that the additional adverse events do not change the overall conclusions of the study.
Earlier this month, the FDA completed a study of 135,000 Medicare patients on Pradaxa or warfarin. They concluded that Pradaxa had a higher risk of gastrointestinal bleeding than warfarin, but a lower risk of stroke and death.
Boehringer is facing over 2,000 lawsuits from people who accuse the company of concealing risk-information linking Pradaxa and serious bleeding. Pradaxa has no reversal agent — unlike warfarin, which can be reversed with a dose of Vitamin K. Lawsuits are centralized in federal court in Illinois and the first “bellwether” trials are set for September 2014 through March 2015.
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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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