Pradaxa side effects that include life-threatening hemorrhaging, heart attack and stroke are the cause of action in current lawsuits against drug maker Boehringer Ingelheim.

Approved by the U.S. Food and Drug Administration in 2010 for the treatment of the risk of stroke that comes with atrial fibrillation, the medication soon began generating dozens of adverse event reports from patients who had experienced serious internal bleeding as well as cardiac arrest and stroke.

Ironically, stroke is one of the medical conditions Pradaxa was intended to prevent. Attorneys are currently investigating potential Pradaxa claims in connection with ongoing litigation against Boehringer Ingelheim.

About Pradaxa Side Effects

Pradaxa (dabigatran) is part of a class of prescription medications known as “Novel Oral Anti-Coagulants,” or NOACs. Commonly called “blood thinners,” these drugs actually work by inhibiting the blood clotting process. NOACs were developed as an alternative to warfarin, a 70-year-old medication that has been the traditional first-line treatment for patients at risk for embolism and stroke.

The problem with warfarin is that it interacts with many other prescription drugs, making it problematic for elderly patients who may take several different drugs a day. There are also numerous dietary restrictions since warfarin works by disabling the action of vitamin K, a key element in the clotting process. On the other hand, hemorrhaging due to warfarin is easily treated by dosing the patient with vitamin K.

Pradaxa is a “thrombin inhibitor.” Instead of working on vitamin K, it disables the action of the enzyme that allows blood clots to form. The main selling point of NOACs has been that they have far fewer drug interactions; thus, less patient monitoring is necessary. However, until 2015, there was no available antidote for Pradaxa when a patient began suffering serious, life-threatening internal bleeding.

FDA Says Pradaxa Problems Were Overstated

In 2013, the FDA issued a report which stated that reports of Pradaxa side effects, i.e. hemorrhaging, had been “somewhat exaggerated.” This report was based on a clinical study, known as RE-LY. That study, which compared Pradaxa with warfarin in terms of safety and efficacy, had nonetheless been called into question by medical experts at the University of British Columbia two years earlier.

In a letter published by the Therapeutics Initiative, the “comparison between warfarin and dabigatran was not blinded…outcomes are subject to performance and ascertainment bias favoring dabigatran.”

The following year, a correction was published in the New England Journal of Medicine, in which the RE-LY study was “reevaluated for possible underreporting of events.” Finally, in February 2012, the lead author of the RE-LY study disclosed that he had a “relevant financial relationship” with Boehringer Ingelheim, to which he served as an “adviser or consultant.”

More Problems With Pradaxa?

In April 2013, researchers at the University of North Carolina added to the list of Pradaxa side effects, finding an association between Pradaxa and increased risk and severity of viral infections such as flu and myocarditis, an inflammation of the heart muscle.

In October 2018, a jury in West Virginia ordered Boehringer Ingelheim to pay $1.25 million to the family of a woman who died from severe hemorrhaging after taking Pradaxa. Most Pradaxa claims that had been filed in federal courts were consolidated into multidistrict litigation; in 2014, Boehringer Ingelheim settled 4,000 cases for $650 million.

In addition, the defendant was ordered to pay $95 million to the federal government over allegations that it had engaged in “improper marketing;” specifically, the drug maker claimed that patients never needed to have their blood tested for levels of the medication, so many patients unknowingly had too much dabigatran in their systems.