What may be the first wrongful death lawsuit involving Pradaxa bleeding side effects has been filed by the family of a woman in Tennessee. The lawsuit alleges that the deceased plaintiff suffered a fatal gastrointestinal bleed due to her use of Pradaxa.
In the U.S., Pradaxa was approved for use to prevent strokes and blood clots in people with atrial fibrillation in October 2010, but has been available overseas since 2008. In recent months, however, as the number of people using Pradaxa has increased so to have concerns about its possible bleeding side effects.
Like most blood thinners, Pradaxa carries a risk of bleeding. However, while warfarin, the blood thinner was meant to replace, there is no antidote to Pradaxa bleeding.
In December, the U.S. Food & Drug Administration (FDA) said it was evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa, but did not indicate how many such reports it had received.
The month prior the drug’s maker had acknowledged receiving 260 reports of fatal bleeding
However, the month prior the drug’s maker had acknowledged receiving 260 reports of fatal bleeding among Pradaxa patients worldwide, including 12 reported in the U.S.
According to her family’s lawsuit, Nancy Brummett was hospitalized with a gastrointestinal bleed after having been prescribed Pradaxa in January 2011. At the time, she had been taking Pradaxa for about two months. She was released from the hospital, but subsequently died, less than three months after she began using Pradaxa.
Her family’s lawsuit alleges that Pradaxa’s maker, Boehringer Ingelheim, created a defective product that is no safer than older blood thinners, and lacks an antidote for reversing bleeding side effects. The lawsuit argues that important information about the lack of an antidote was buried in small print in a medication guide under the heading of “overdose.”
The complaint also alleges that Boehringer failed provide any guidance on how to deal with bleeding events when they arise, the lawsuit claims. Finally, the lawsuit faults the 150 mg standard dosing for Pradaxa, pointing out that warfarin is dosed specifically for individual patients.