May 13, 2014 — The blood-thinner Pradaxa (dabigatran) is associated with higher rates of gastrointestinal bleeding than warfarin, but lower rates of stroke and death, according to a Safety Communication published by the U.S. Food and Drug Administration (FDA).
Conclusions were based on a review of 134,000 Medicare patients aged 65 and older who started Pradaxa or warfarin. Pradaxa was associated with a lower rate of clot-related strokes, bleeding in the brain, and death compared to warfarin.
However, Pradaxa was associated with a 28% higher rate of gastrointestinal bleeding than warfarin. Both drugs had a similar rate of heart attack (myocardial infarction).
The results of the FDA study are consistent with the RE-LY clinical trial, which Boehringer Ingelheim used to gain approval for Pradaxa. However, the FDA study is an improvement on the RE-LY trial. According to the FDA:
“Importantly, 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 mostly reassuring from a safety standpoint, and the FDA has not updated the label or recommendations for using Pradaxa. Since Pradaxa was approved in 2010, it has been the subject of numerous investigations into bleeding risks. Unlike warfarin, which can be reversed with Vitamin K, Pradaxa has no reversal agent.
In March, the FDA published a perspective in the New England Journal of Medicine blaming a large number of adverse event reports involving bleeding from Pradaxa on “stimulated reporting,” which provided a distorted estimate of bleeding events compared to warfarin.
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