Pradaxa Safety QuestionedSep 13, 2016
Plaintiffs in the Pradaxa litigation are calling into question whether or not the blood thinner is safe. Pradaxa, known generically as dabigatran, is manufactured by Boehringer Ingelheim to reduce the risk of blood clots and related injuries, such as stroke and pulmonary embolism, in patients with atrial fibrillation. As with all anticoagulants, Pradaxa carries a risk of excessive bleeding. However, the drug has raised safety questions due to the lack of an antidote to reverse the bleeding.
The lawsuits allege that Boehringer Ingelheim failed to warn about the risk of uncontrollable bleeding with Pradaxa. Instead, plaintiffs allege, the company touted the drug as a superior alternative to warfarin, a decades-old medication that requires regular blood monitoring and dietary restrictions. Plaintiffs allege injuries such as hemorrhages and gastrointestinal bleeding. In some cases, the bleeding was fatal.
The U.S. Food and Drug Administration (FDA) approved Pradaxa in 2010. Plaintiffs allege that clinical trials used to gain drug approval show that the anticoagulant presents life-threatening risks. One clinical study, known as RE-LY, compared Pradaxa to warfarin. Patients taking Pradaxa had higher rates of gastrointestinal bleeding compared to warfarin, researchers found. The rate of major bleeds was comparable. These findings prompted the FDA to launch an investigation in December 2011.
Reportedly, Boehringer Ingelheim reported at least 260 fatal cases of bleeding associated with Pradaxa between March 2008 and October 2011. Additionally, the Institute for Safe Medication Practices published a report showing that Pradaxa was implicated in 932 reports of serious adverse events in the first quarter of 2011. This includes 120 deaths and 543 injuries requiring hospitalization.
Lawsuits filed over Pradaxa were consolidated into a federal multidistrict litigation in Illinois. Plaintiffs alleged that Pradaxa was unsafe, and alleged the Boehringer Ingelheim failed to warn about the risks. The drug maker agreed to settle all 4,000 lawsuits for $650 million in May 2014. Still, that does not necessarily mean the end of litigation over Pradaxa. New plaintiffs can still file lawsuits over Pradaxa bleeding injuries.