Pradaxa Study Finds Increased Heart Attack Risk

A recent study involving the review of clinical data on the controversial new anticoagulent Pradaxa found an increased risk of heart attacks when compared to warfarin, but an overall decrease in myocardial ischemic events. 

The research comes shortly after the FDA announced that it was conducting a safety review of Pradaxa bleeding problems after the blood thinner has been linked to a number of post-marketing reports involving severe internal bleeding and other complications.

In a study published on the website for the medical journal Circulation, the journal of the American Heart Association, researchers went through the results of a prior clinical trial involving Pradaxa.

Known as the RE-LY study, the clinical trial compared Pradaxa with warfarin, an older blood thinner, which is sold under the brand name Coumadin.

Researchers found that the rate of heart attacks was slightly increased at both high doses and low doses when compared with warfarin in patients being treated for stroke prevention. However, Pradaxa appeared to have an overall net clinical benefit for its patients over the older drug.

Shortly after Pradaxa was approved in October 2010, concerns emerged about a potential increased risk of bleeding with Pradaxa, as hundreds of adverse events were reported to the FDA within the first months the drug was on the market.

As of October 31, 2011, more than 260 deaths among users of Pradaxa involving internal bleeding were reported worldwide.

Pradaxa (dabigatran) was introduced as a superior alternative to warfarin, as it is supposedly easier to use and requires less monitoring. However, warfarin can be quickly counteracted by doses of Vitamin K when a bleeding problem occurs, while there is no such quick fix for a bleeding problem with Pradaxa.

As concerns rise among federal regulators and the medical community, a number of lawyers are reviewing potential Pradaxa lawsuits on behalf of individuals throughout the United States, alleging that Boehringer Ingelheim failed to adequately warn about the risk of internal bleeding.