Pradaxa (dabigatran etexilate mesylate) is a popular anticoagulant drug manufactured by German pharmaceutical company Boehringer Ingelheim. It was approved by the U.S. Food and Drug Administration (FDA) in 2010 for the prevention of blood clots and strokes in patients with atrial fibrillation and abnormal heart rhythm. One of the most prescribed drugs in its class, one reason Pradaxa is attractive to many patients is because it offers greater convenience than “old-school” blood-thinners—like warfarin—which require patients to avoid certain types of foods and submit to regular blood tests and monitoring.
Although Pradaxa is convenient, and effective at preventing blood clots and strokes in patients with atrial fibrillation and abnormal heart rhythm, use of this drug isn't without side effects. Recent studies have linked Pradaxa to an array of serious side effects and complications, including uncontrollable bleeding and even death.
Uncontrollable Bleeding for Patients on Pradaxa
Uncontrollable bleeding is, without a doubt, one of the most serious side effects or complications linked to Pradaxa. While most, if not all, blood thinning medications are capable of causing internal bleeding, the risks posed by Pradaxa are unique in several ways.
For example, uncontrollable internal bleeding is the leading cause of death for patients taking Pradaxa. Additionally, although the FDA approved Pradaxa in 2010, an antidote for the drug wasn't approved until 2015. This means for five years, there wasn't a safe or reliable way to reverse the blood-thinning effects of Pradaxa in patients experiencing uncontrollable bleeding.
Many patients taking anticoagulants have questioned why antidotes were available for drugs like warfarin but not Pradaxa. This largely has to do with the differences in the ways these medications work. Warfarin inhibits the clotting process by reducing the amount of vitamin K in the bloodstream; if an internal bleeding event were to occur, doctors could simply administer vitamin K to reverse the drug's effects. Pradaxa, on the other hand, inhibits a clotting enzyme called thrombin, which denies platelets the ability to form clots—a function that isn't as easily rectified.
The FDA fast-tracked approval of Boehringer Ingelheim's Praxbind® antidote in October 2015 as a response to the more than 500 internal bleeding deaths linked to use of this prescription drug.
Symptoms of Pradaxa-related internal bleeding can include:
- Easy bruising
- Unusual bleeding from the mouth, nose, rectum or vagina
- Unusually heavy menstrual bleeding
- Weakness or fainting
- Purple or red spots under the skin
- Blood in the urine or stools
- Swollen or painful joints
- Coughing up vomit, blood or a coffee grounds-like substance
Patients on Pradaxa should seek immediate medical attention if they experience any bleeding-related symptoms.
Other Pradaxa Side Effects to Note
Pradaxa is also linked to a number of other concerning side effects, including:
- Upset stomach
- Nosebleeds (and other forms of minor bleeding)
- Stomach or abdominal pain
Some people may dismiss these side effects as being simply inconvenient or uncomfortable. However, it's important to remember that when taking a blood-thinning medication such as Pradaxa, these side effects may signal more serious health problems or complications. Pradaxa patients who experience severe heartburn, nausea, or vomiting should contact a physician as soon as possible.
Pradaxa can also cause allergic reactions in some patients. Symptoms include:
- Trouble breathing
- Swelling of the throat, face, lips, or tongue
Did You Experience Serious Pradaxa Side Effects?
Did you suffer serious side effects while taking Pradaxa? Have you lost a loved one due to a Pradaxa-related uncontrollable internal bleeding event? If so, you may be able to file a personal injury or wrongful death lawsuit to seek compensation from Pradaxa's manufacturer, Boehringer Ingelheim. If you're considering taking legal action, McGartland Law can help. Our firm has 30 years of experience handling injury cases for clients all across the country. Contact us today to schedule an appointment for a free, no-obligation initial consultation to discuss the details of your potential Pradaxa lawsuit.