The blood thinner Pradaxa, manufactured by Boehringer Ingelheim Pharmaceuticals, has been linked to severe internal bleeding, gastrointestinal hemorrhaging and other serious side effects.

Pradaxa (dabigatran) is a newer oral anticoagulant  approved by the FDA in 2010.

The blood thinner medication is in the class of drugs known as direct thrombin inhibitors and works by inhibiting an enzyme in the blood involved in clotting. The drug is often used as an alternative to warfarin to prevent strokes associated with atrial fibrillation.

However, recent studies have shown that over 15% of all Pradaxa users may suffer from internal hemorrhaging as a side effect of the drug. In older patients, the risk of serious Pradaxa hemorrhaging may even be greater with Pradaxa than with warfarin. There have been hundreds of “bleeding out” deaths alleged to have been caused by the new generation blood thinner.

Symptoms of Pradaxa bleeding injuries include:

• Brain hemorrhaging
• Internal bleeding
• Gastrointestinal (GI) bleeding
• Kidney bleeding
• Death from “bleeding out”

Concerns About Pradaxa Safety

Unlike warfarin, there is no antidote for Pradaxa internal hemorrhaging. (If someone starts bleeding on warfarin, a doctor can administer an emergency dose of Vitamin K to stem the damage; no such remedy exists for Pradaxa.) Once someone starts “bleeding out” from Pradaxa, it is often fatal.

Emphasizing this point is the Food and Drug Administration’s (FDA) assessment that has linked the medication to thousands of adverse events.  In fact, 542 of those events proved to be lethal.  Additional evidence was found when, in 2011, the Institute of Safe Medication Practices connected Pradaxa to more injuries and deaths than any other drug among the 800 it evaluated.

Pradaxa Lawsuits

Pradaxa lawsuits have largely originated from one specific type of side effect or set of complications: uncontrolled bleeding.  Additional claims included misrepresenting the safety and effectiveness of the drug compared to warfarin, and not having improper dosing information.

In May 2014, Boehringer Ingelheim announced that it would settle an initial round of 4,000 Pradaxa lawsuit settlements for $650 million.  This settlement resolved the company’s federal and state lawsuits over the much maligned medication, with the primary claim being the inability for the human body to prevent uncontrolled bleeding, as well as the lack of remedy after taking the drug.

Although Boehringer Ingelheim Pharmaceuticals agreed to settle thousands of Pradaxa lawsuits, the drug maker is still facing thousands more claims in federal court, alleging that users suffered severe and often fatal bleeding problems after using the controversial anticoagulant.

In August of 2012, Judge David R. Herndon of the U.S. District Court for the Southern District of Illinois consolidated over 2.600 federal Pradaxa lawsuits into multidistrict litigation (MDL) known as In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385.  MDLs are used to streamline the legal process, cut costs, and reduce possible conflicts from multiple judges presiding over similar claims.

If you or someone you love has suffered from adverse and life-threatening Pradaxa complications such as internal bleeding, you may be entitled to work with a Pradaxa lawyer and file a Pradaxa lawsuit to recover damages for your suffering.