Pradaxa® (dabigatran) is a prescription blood-thinning medication that has been approved by the Food and Drug Administration (FDA) to reduce the risk of stroke in people with non-valvular atrial fibrillation (AFib).
Pradaxa is in a class of anticoagulant drugs called direct thrombin inhibitors, which attach to clotting agents in the blood and reduce its ability to clot.
Unlike other blood thinners, Pradaxa doesn’t require monthly blood tests and has no known counteracting drug. This can make it more difficult to stop bleeding in patients who are taking Pradaxa. Between October 2010 and August 2011, approximately 1.1 million Pradaxa prescriptions were dispensed from U.S. pharmacies.
Serious Bleeding Can Occur
The FDA recently began evaluating reports that serious bleeding is more common in patients using Pradaxa than in patients using other blood thinners. Boehringer Ingelheim, the maker of Pradaxa, has reported 260 fatal bleeding events related to Pradaxa between March 2008 and October 2011.
People at the highest risk for abnormal bleeding from Pradaxa use include people who:
- Are 75 years old or older;
- Have existing kidney problems;
- Have stomach bleeding or an ulcer; or
- Are taking other drugs that increase the risk of bleeding, including aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), and other blood thinners.
Symptoms to Notice
Pradaxa users should call their doctors immediately if they notice any of the following symptoms:
- Coughing up or vomiting blood;
- Frequent nose bleeds;
- Heavy menstrual bleeding;
- Pink or brown urine; and
- Red or black stools.
People taking Pradaxa shouldn’t stop using the drug without first talking to their doctors, as this can increase the risk of having a stroke. It’s also important to notify healthcare professionals about Pradaxa use before having any surgery or dental procedures.
Pradaxa Injury Help
If you or a loved one has taken Pradaxa and suffered from severe bleeding resulting in hospitalization, or if a loved one died from cerebral hemorrhage or other life-threatening bleeding event, you need the help of a Pradaxa drug injury lawyer. You may be entitled to compensation. Call us or complete a free case evaluation form today. We want to help.
Pradaxa is a registered trademark of Boehringer Ingelheim. This law firm is not associated with, sponsored by, or affiliated with the U.S. Food and Drug Administration or Boehringer Ingelheim.