Pradaxa has become a bigger legal headache for Boehringer Ingelheim. The German drugmaker says it's facing more than 2,000 lawsuits in the U.S., filed by patients claiming the anticoagulant drug caused severe or fatal bleeding.
The news of the lawsuit numbers comes on the heels of a new FDA look at Pradaxa's safety. Though the agency has reviewed safety data on Pradaxa before, it has now decided to dig into its Mini-Sentinel database to compare outcomes in Pradaxa and warfarin patients.
|Pradaxa is under fire again.
The first of a new group of alternatives to the traditional clot-buster warfarin, Pradaxa hit the market in 2010, and as it came into real-world use, side-effect reports started to mount. Though the risk of bleeding for Pradaxa patients doesn't appear to be higher than it is for warfarin users, the sheer number of side-effect reports triggered concern among regulators and doctors.
As Boehringer has pointed out, rates of serious bleeding in the marketplace have more or less equaled those seen in clinical trials. But physicians have been particularly worried by the fact that, unlike warfarin, Pradaxa and its next-gen rivals have no antidote. Without one, bleeding is difficult to stop once it begins. And obviously, statistics mean little to individual patients and their families, so the lawsuits started to roll in.
Boehringer has been working on an antidote, as have Pfizer ($PFE) and Bristol-Myers Squibb ($BMY), which sell a competitor, Eliquis; and Johnson & Johnson ($JNJ) and Bayer, which market Xarelto.
"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," the company said in a written statement (as quoted by Reuters).
The behind-the-scenes discussion of Pradaxa's safety went public last week, showing that marketing managers were worried about an internal report showing that the drug would be safer to use if patients' blood levels were routinely monitored. Because freedom from such monitoring is one of Pradaxa's selling points--warfarin is notoriously difficult to dose and requires regular testing--some company officials wanted to downpedal or even bury the report, The New York Times reported.
In response, Boehringer told The Times that the recently unsealed documents "represent small fragments of the robust discussion and debate that is a vital component in all scientific inquiry, and in the research and development of any important medication such as Pradaxa."