Pradaxa Internal Bleeding Hemorrhaging Side Effects

Pradaxa (dabigotran) is a blood thinner, approved by the U.S. Food & Drug Administration (FDA) in October 2010, used to prevent stroke and blood clots in people with an irregular heart beat (atrial fibrillation). Shortly after the medication was approved, 505 cases of hemorrhaging were reported to the FDA.

Side effects can range from gastrointestinal (GI) irritation to life-threatening and even fatal hemorrhaging. Often, this bleeding takes place in the GI tract, which can result in bloody stools and vomiting. However, patients have also experienced dark and bloody urine, and bruises that do not heal. In the most serious cases, cerebral hemorrhaging (bleeding in the brain) may occur.

In addition to the risks associated with hemorrhaging, a study published in the January 2012 issue of Archives of Internal Medicine reports that patients taking dabigotran have a 33% greater chance of developing heart disease or experiencing cardiac arrest.

What are the Symptoms of Pradaxa Bleeding Injuries?

Coughing up blood
Dizziness
Frequent Nose Bleeds
Headaches
Joint pain or swelling
Lethargy
Pink or brown urine
Red or black tarry stools
Unusual bruising or bleeding
Vomiting that resembles blood or looks like coffee grounds
Weakness and swelling of the arms, hands, feet, ankles or lower legs

Clinical Trial of Pradaxa Found Internal Bleeding Risks

The RE-LY clinical trial found that up to 16.4% of Pradaxa users may experience internal hemorrhaging. The study also found that:

17.4% of patients taking Pradaxa experienced internal bleeding requiring medical attention
3.3% of users experienced major Pradaxa internal bleeding
1.5% of users experienced life-threatening Pradaxa hemorrhaging
0.3% of users experienced Pradaxa brain hemorrhaging

What Can You Do?

If you have taken Pradaxa and have experienced serious Pradaxa side effects, you may want to consider your potential legal claim. For more information, or to speak with someone experienced in handling Pradaxa injury cases call us toll-free at 800-755-0098 or fill our our free case review form. Zimmerman Reed is experienced in handling defective drug cases and we welcome any questions you may have.