A large collection of plaintiffs has filed a Pradaxa lawsuit against drug manufacturer Boehringer Ingelheim for a variety of allegations regarding the medication and uncontrollable bleeding side effects.

In October 2010, the FDA approved Pradaxa as an anticoagulant, commonly called a blood thinner medication, that reduces the chances of a stroke in patients with atrial fibrillation, a type of irregular heartbeat that occurs when or both upper heart chambers function erratically.

Blood clotting occurs more frequently in people who have atrial fibrillation, which leads to them having an increased risk of stroke that is five times that of the general population.

While atrial fibrillation itself is not life-threatening, strokes that are due to the condition are more likely to be severe, with a higher incidence of death and disability.

Pradaxa Internal Bleeding

While Pradaxa has prevented blood clots from forming, it has also led to internal bleeding, such profuse bleeding that patients have died. While an antidote called Praxbind was introduced in the fall of 2015, it was allegedly too late for the plaintiffs in the Pradaxa lawsuit.

By November 2010, at least 260 people had allegedly fatally bled out after taking Pradaxa. The FDA states that Pradaxa is one of the top causes of drug-related adverse events it receives in overall reports.

Before 2012, Boehringer Ingelheim did not warn that Pradaxa-induced bleeding was irreversible and that no reversal agent was available at that time.

Shockingly, the company allegedly had developed an antidote even before Pradaxa was approved to be sold in the United States. Boehringer Ingelheim didn’t seek approval of Praxbind, the antidote/reversal agent, until February 2015.

Pradaxa Marketing Claims

One of the biggest selling points Pradaxa has made to doctors and patients is that the drug does not require blood monitoring.

This was a way Pradaxa marketers were allegedly attempting to prove its superiority over the previous go-to blood thinner medication Coumadin, which requires frequent blood monitoring.

Coumadin has been used for more than 50 years, and most side effects can be controlled through monitoring and the use of vitamin K, which minimizes bleeding problems.

The Pradaxa lawsuit states, “Pradaxa is not safer than Coumadin. While offering some level of convenience, from a safety perspective compared to Coumadin, its risks greatly exceed any such conveniences, which was the basic component in the defendants’ marketing launch.”

Pradaxa Lawsuit Says Doses Not Monitored

The Pradaxa lawsuit alleges that because there is no accurate test to monitor the level of the medication in a patient’s blood, this unknown data adds to the drug’s dangers.

The Pradaxa lawsuit argues that the drug needs to be monitored in order to be dosed properly for each individual patient. At too low a dose, a patient is at risk of blood clots and possible stroke. If a dose is too high, the patient is at risk of developing life-threatening internal bleeding.

If this is the case, then Pradaxa’s marketing claims that the blood levels “do not require monitoring” should be replaced with “cannot be monitored,” plaintiffs claim.

The Pradaxa Lawsuit is Case No 1622-CC01168, in Missouri Circuit Court, Missouri Circuit Court, Twenty-Second Judicial Circuit (City of St. Louis).