Pradaxa is a blood thinner usually prescribed to people who have recently undergone surgery or to prevent stroke in people with atrial fibrillation. Despite its effectiveness for some, many users of Pradaxa have suffered serious internal bleeding events. The FDA has received more than 4000 adverse event reports concerning Pradaxa users, more than 500 of which were fatal.
Pradaxa (dabigatran) is an anticoagulant that assists in the prevention of blood clots. The drug is used to reduce the risk of stroke and blood clots in people with atrial fibrillation. It is also used to treat blood clots in the veins of the legs or lungs in people who have recently undergone surgery or who have previously experienced deep vein thrombosis or pulmonary embolism.
Pradaxa side effects vary from user to user. It can trigger an allergic reaction and you should contact your doctor immediately if you experience any signs of a reaction. Common side effects of Pradaxa include digestive symptoms including stomach pain, indigestion, and heartburn.
More serious side effects of Pradaxa use include:
- Any type of bleeding that will not stop
- A headache, weakness, dizziness, faintness
- Easy bruising
- Unusual bleeding (nose, mouth, vagina, or rectum)
- Purple or red spots under your skin
- Blood in your urine or stools, or black or tarry stools
- Coughing up blood or vomit that looks like coffee grounds
- Pink or brown urine
- Joint pain or swelling
- Heavy menstrual bleeding
- Symptoms associated with a spinal blood clot, including back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control
If you experience any of these symptoms you should seek medical attention as soon as possible.
It should also be noted there is no antidote to stop Pradaxa users from bleeding once an event begins.
An investigation also revealed the FDA was “permissive” in its approval of Pradaxa and approved the drug on the basis of a single poorly designed clinical trial that failed to identify certain safety concerns.
Numerous lawsuits have been filed against Boehringer Ingelheim, maker of Pradaxa, by users and their loved ones, many of which were combined into multidistrict litigation to prevent the court system from becoming overwhelmed by Pradaxa lawsuits.
After users of Pradaxa accused the manufacturer of being aware of the risks associated with the drug but failing to warn the public, Boehringer Ingelheim chose to settle all pending cases in 2014 for $650 million.
Since that settlement, new lawsuits have been filed by users who were harmed by Pradaxa but not included in the original settlement. Thousands of new patients have experienced internal bleeding since the original lawsuits were filed and now, legal action will be taken in a special state court. Those familiar with the original case believe the $650 million settlement was not enough to compensate users for their injuries and medical treatment, nor did it provide adequate compensation for people who lost loved ones because of Pradaxa.
In July, a Delaware judge refused to dismiss a Pradaxa lawsuit, finding favor with the plaintiff’s claims that Boehringer Ingelheim failed to warn of the lack of an antidote, nor did they notify patients and doctors of the increased risk of gastrointestinal bleeding.
Patients or family members of those who suffered serious or fatal bleeding events after using Pradaxa could be eligible for compensation for their injuries or loss through the latest Pradaxa lawsuit.
If you or a loved one was injured by Pradaxa, you might be eligible to file a Pradaxa lawsuit. Each case is unique and must be evaluated separately by a legal expert.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.