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FDA Study Links Pradaxa and Higher GI Bleeding than Warfarin

FDA Study Links Pradaxa and Higher GI Bleeding than Warfarin

May 13, 2014 — The U.S. Food and Drug Administration (FDA) has published a Safety Communication after concluding that Boehringer Ingelheim’s blood-thinning drug Pradaxa (dabigatran) has lower rates of stroke and death, but higher rates of gastrointestinal bleeding than warfarin.

The FDA study evaluated data on 134,000 Medicare patients who were at least 65 years old and starting treatment with Pradaxa or warfarin. Pradaxa was associated with a 28% increased risk of gastrointestinal bleeding, but a lower risk of clot-related strokes (ischemic stroke), bleeding in the brain (cerebral hemorrhage), and death. The risk of heart attack was similar for Pradaxa and warfarin.

The FDA said the study is important due to the larger sample size and analytical methods:

“The new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern.”

The study is reassuring from a safety perspective. Conclusions were very similar to those found in the RE-LY clinical trial, which the FDA reviewed before approving Pradaxa in 2010. Since then, nearly 1 million patients have used Pradaxa. Many experts have raised concern about bleeding from Pradaxa because unlike warfarin, Pradaxa has no reversal agent to counteract its blood-thinning effects in an emergency.

In March, the New England Journal of Medicine published a report in which the FDA blamed a large spike in bleeding-related adverse events on “stimulated reporting,” which made it appear that Pradaxa had a higher rate of bleeding than warfarin.

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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