On Thursday, German drug maker Boehringer Ingelheim acknowledged it is facing more than 2,000 lawsuits in the United States claiming its blockbuster blood-thinner drug Pradaxa (dabigatran) causes severe and fatal bleeding.
The company confirmed the number of cases, which had been reported by the German newspaper Handelsblatt, adding that the company had to weigh the risk of known side effects against the drug’s life saving potential. “We are certain that we can show in the legal cases that we have worked very carefully and responsibly in research, development and marketing of Pradaxa,” said the company’s written statement, reported by Reuters.
Pradaxa is the first drug in a new class of medicines designed to replace warfarin, prescribed for more than 50 years to prevent strokes in patients suffering from atrial fibrillation, a form of irregular heartbeat common among the elderly. While blood thinners cut the rate of fatal or debilitating strokes, they increase the risk of internal bleeding, which can also prove fatal, according to Reuters.
Boehringer cited a recent study by the U.S. Food and Drug Administration (FDA) as showing that Pradaxa users ran a lower risk of severe bleeding than patients on warfarin, according to Reuters. Pradaxa—one of a trio of recently approved blood thinners, along with Xarelto (rivaroxaban), and Eliquis (apixaban)—had sales of $1.5 billion in 2012, its second year on the market. The New York Times reports that Pradaxa has been prescribed to 850,000 patients, but has also been linked to more than 1,000 deaths.
Earlier this month, federal judge David Herndon unsealed documents revealing that Boehringer Ingelheim tried to quash results of an internal study it feared would damage Pradaxa sales. Judge Herndon oversees thousands of lawsuits, alleging the drug maker failed to properly warn about Pradaxa’s risks. One of Pradaxa’s strong selling points is that it does not require regular blood tests, as warfarin does, but the study suggested that many Pradaxa users do in fact need blood testing because they may have either too little or too much of the drug in their bloodstream. The Times reports that these research conclusions alarmed Boehringer executives and led to efforts to suppress the study.