Pradaxa is a blood thinner used for stroke prevention. It received U.S. Food and Drug Administration (FDA) approval in October 2010. Pradaxa was designed after a similar drug called warfarin, which was sold under brand names such as Coumadin and Jantoven. Warfarin was launched in 1954, and to-date is still the most-prescribed blood thinner on the market.
Pradaxa was designed to require less maintenance and create fewer side effects than its predecessor. By 2012, there were more than 3.7 million Pradaxa prescriptions in the United States. The German manufacturer, Boehringer Ingelheim, reached the $1 billion mark in total sales in the same year. Along with these immense sales came claims that Pradaxa caused more than 500 deaths due to uncontrollable bleeding and hemorrhaging. Hundreds of lawsuits are being filed against Boehringer Ingelheim.
What Is Pradaxa?
Pradaxa (dabigatran) is an anticoagulant. It, along with warfarin, is used to treat those who suffer atrial fibrillation (AF) and face risk of blood clots and stroke. These drugs are not meant for those who have a history of heart disease. Pradaxa is taken easily in capsule form. Doses range from 75 to 150 milligrams each.
While warfarin and Pradaxa treat the same condition, they function very differently. Pradaxa is part of the drug class labeled thrombin inhibitors. Thrombin is a clotting protein in the body. Pradaxa works to inhibit thrombin so that the patient’s blood is thinned and less likely to clot, which often leads to stroke. It is advised that those with kidney problems should take lower doses and be more carefully monitored.
Common Pradaxa Side Effects
As with other anticoagulants, it is not uncommon for Pradaxa patients to experience bruising or bleeding due to minor cuts. Additionally, all patients using drugs like Pradaxa should notify dentists and doctors prior to medical or surgical procedures. If not treated carefully, bleeding complications can occur.
Excessive bleeding is most common in Pradaxa patients who are over the age of 75, have
kidney problems, or suffer a stomach ulcer which has caused bleeding in the intestines or stomach. Other than these standard risks, Pradaxa has minimal side effects. However, patients should not confuse fewer side effects with increased safety.
Common Pradaxa side effects may include:
- Stomach pain
Severe Pradaxa Side Effects
Severe Pradaxa side effects include heart attack, liver failure, uncontrolled bleeding, and death in some cases. While bleeding can be a common side effect, serious cases can result in brain and central nervous system hemorrhages. These conditions can be equally as harmful as a stroke if they become out-of-hand.
In 2011, Pradaxa patients reported 817 adverse event reports to the FDA. An aggregate of database, manufacturer, and health professional reports shows that 3,781 of these severe adverse events occurred in the same year. Of these, 542 resulted in death of the patient. It is recommended that patients seek immediate medical attention if they experience symptoms such as unusual bruising, pink or brown urine, or coughing up blood.
There are currently more than 250 federal lawsuit claims against Boehringer Ingelheim. These claims allege severe complications, such as hemorrhaging and death of patients using Pradaxa. While the lawsuit numbers are currently in the hundreds, it is expected that thousands more claims may follow.
These federal claims have been grouped into a multidistrict litigation (MDL). In an MDL, similar federal claims are all processed in the same district. Once the pretrial process is complete, the cases are returned to their respective federal districts for the trial. MDL is used to streamline the process, cut costs, and reduce possible conflicts from multiple judges presiding over similar claims. The Pradaxa MDL is assigned to the U.S. District Court in the Southern District of Illinois.