Pharmaceutical

Lawsuits claim Pradaxa never warned that bleeding side effects may not be reversible

Gavel Scales of Justice American flag square Lawsuits claim Pradaxa never warned that bleeding side effects may not be reversible The newly approved blood thinner Pradaxa works faster and requires fewer medical exams and dietary restrictions than the long-used warfarin, but it may result in dangerous and sometimes fatal internal bleeding events.

Pradaxa was approved by the Food and Drug Administration (FDA) two years ago to prevent strokes in patients with a common heart condition known as atrial fibrillation. It was the first anticoagulant approved to treat atrial fibrillation patients since warfarin was cleared more than 50 years ago.

Pradaxa was an attractive alternative to warfarin because there were fewer interactions and patients didn’t need to be as closely monitored. Pradaxa soon reached blockbuster status, bringing in more than a billion dollars over the course of a calendar year.

Shortly after Pradaxa hit the market, so did reports of serious bleeding events. A review of FDA records from 2011 showed that Pradaxa was associated with more deaths than any other monitored drug.

One serious difference between Pradaxa and its predecessor warfarin is that there is no antidote to reverse the effects of Pradaxa. In many cases bleeding could not be stopped and patients suffered serious disability or death.

“The big reasons there’s been a slow response to putting more patients on Pradaxa is because of significant bleeding,” Dr. Keith Churchwell, executive director of Vanderbilt’s Heart and Vascular Institute, told The Tennessean. “Right now, we don’t have a good mechanism to reverse it.”

Hundreds of lawsuits against the makers of Pradaxa were recently consolidated in a federal court in Southern Illinois. The lawsuit claims that Pradaxa’s makers did not warn patients that internal bleeding – a side effect of the drug – was often irreversible.

Source: The Tennessean