The Dangers of Pradaxa®
If you or a loved one has taken Pradaxa® (dabigatran etexilate mesylate), an anticoagulant or blood thinning medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), and have suffered dangerous, life-threatening side effects such as internal bleeding or hemorrhaging, heart attack, or myocardial infarction (MI), please call The Brad Hendricks Law Firm.
Pradaxa® Approved by FDA in 2010 and Investigated by 2011
In 2010, the United States Food & Drug Administration (FDA) approved Pradaxa®, manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., as a direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Its popularity soon increased due to the perception that it was easier to use and modify than warfarin, with fewer interactions.
An investigation was launched less than one year later in September 2011, after five New Zealand patients died from internal bleeding/hemorrhaging after taking Pradaxa. Mere weeks earlier, Japanese officials had notified the manufacturer that eight-one elderly patients experienced heavy bleeding/hemorrhaging from March 14 to August 11, during which time five patients died. In the United States, the FDA received approximately 3,781 adverse event reports identifying Pradaxa use in 2011 alone—more than reports associated with any other drug monitored by the FDA.
According to the Institute for Safe Medication Practices (ISMP), a blood-thinning medication launched in October 2010 to reduce the risk of stroke in patients with atrial fibrillation, generated “932 serious adverse event” reports during the first quarter of 2011, including:
- 120 deaths
- 25 cases of permanent disability
- 543 cases requiring hospitalization
- 505 cases involving hemorrhages, more than any other monitored drug, including warfarin (which ranked second with 176 cases of hemorrhaging)
Of the reported cases, 120 described the event with terms indicating a “hemorrhagic stroke,” an alarming statistic considering that Pradaxa® is indicated to prevent ischemic strokes.
The ISMP report states that Pradaxa® manufacturer Boehringer Ingelheim was aware of the large number of adverse events reported, but said prescribing information warns about an increased risk of significant and sometimes fatal bleeding. Numerous patients have suffered internal bleeding, brain hemorrhages, and more after simple falls and minor accidents. The number of bleeding deaths associated with Pradaxa® may be as much as five times higher than previously acknowledged.
No Known Antidote for Pradaxa-Related Bleeding
Some doctors fear that there’s nothing they can do in these emergency situations to counteract the effects of Pradaxa®. When serious bleeding events occur in patients taking warfarin, vitamin K can be administered; however, no reversal agent or antidote is available for Pradaxa® patients. Therefore, once the drug is in one’s system, it can be very difficult, if not impossible, to stop bleeding.
The FDA announced in January 2012 that it had approved changes to the Warning and Precautions section of Pradaxa’s labeling to include the following: “Lack of a specific reversal agent; futility of using vitamin K to affect anticoagulant effect.” There is no specific agent known to aid with the reversal of Pradaxa related bleeding. Vitamin K, a known antidote used to counter warfarin-related bleeding, is ineffective. The new labels also warned that Pradaxa’s anticoagulant activity and half-life are increased in patients with renal (kidney) impairment. Pradaxa was hailed as a safer alternative to traditional blood thinners like warfarin; however, warfarin bleeding may be interrupted by administering Vitamin K. Because Vitamin K is not effective to interrupt Pradaxa bleeding, the effects can be deadly. Risks increase with age, according to some reports.
Dangerous Symptoms Associated with Pradaxa®
Although anticoagulants are known to carry some risk of bleeding, patients who have taken Pradaxa® have reported potentially harmful symptoms such as:
- Unusual bleeding/hemorrhaging or bruising
- Unusual gum bleeding or frequent nose bleeds
- Heavier-than-normal menstrual or vaginal bleeding
- Uncontrolled bleeding
- Pink or brown urine or red or black (tar-like) stools
- Unexplained bruising or bruising that gets larger
- Coughing up blood or blood clots
- Vomiting blood or vomiting a substance resembling coffee grounds
- Weakness or swelling of the feet, ankles, lower legs, hands and feet, or other joint pain or swelling
The FDA cautions that those taking Pradaxa® should not stop taking the medication without first consulting a trained healthcare professional as sudden cessation of this medication may increase the risk of stroke. If you or a loved one are taking or have taken Pradaxa®, and have observed or developed any symptom identified above, please contact your healthcare provider immediately. Ask your healthcare professional whether Pradaxa could be the cause of the problem.
Pradaxa® Injury Help You Can Count On
We want to know about your experience with this dangerous drug whose use may lead to fatal internal bleeding or hemorrhaging. Call The Brad Hendricks Law Firm today at (501) 221-0444 or (800) 603-5100 for a free consultation with an experienced team of lawyers and professionals. If you or a loved one has been harmed by Pradaxa®, you can count us to fight to make sure you are compensated for your injuries.