Wednesday, May 28, 2014

Pradaxa Maker Reaches $650 Million Settlement in State and Federal Litigation

Drug maker Boehringer Ingelheim announced today that it had reached a $650 million settlement of state and federal cases involving the blood thinner Pradaxa (dabigatran).

Though the company says it “stands resolutely behind” Pradaxa and believes the claims in the lawsuits lack merit, a company news release says the settlement allows BI to avoid the “distraction and uncertainty of lengthy litigation,” according to

This settlement is expected to resolve about 4,000 claims and Boehringer Ingelheim reportedly expects most, if not all, plaintiffs to accept the settlement, Insurancenewsnet reports. The company says Pradaxa is superior to the older blood thinner warfarin in reducing ischemic strokes, while having a similar rate of major bleeding events. Ischemic strokes account for nearly nine out of every 10 strokes caused by atrial fibrillation, a heart rhythm problem.

On May 13, the Food and Drug Administration (FDA) issued a Drug Safety Communication with results from a Medicare study that compared new users of Pradaxa and warfarin. The FDA reports that Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death compared to warfarin, but Pradaxa had an increased risk of major gastrointestinal bleeding, according to Vitamin K is an antidote to warfarin bleeding, but there is no antidote for bleeding with Pradaxa, making such bleeding very dangerous.
Pradaxa belongs to a new class of blood thinners, drugs developed to replace warfarin, which has been prescribed for more than 50 years. While blood thinners reduce the rate of fatal or debilitating strokes, they increase the risk of internal bleeding, which can be fatal, Reuters reports. The new blood thinners have been successful in the market because, thus far, patients using them have not needed the regular blood testing and dietary restrictions necessary with warfarin. But The New York Times reports that new studies suggest that Pradaxa users may need blood testing because individuals’ metabolic differences can leave then with too little or too much of the drug in their bloodstream. Too little diminishes the drug’s effectiveness in preventing strokes and too much increases the bleeding risk.

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