FDA Looking Into Reports of Pradaxa Bleeding

Since October 2010, Pradaxa has been widely used to reduce the risk of stroke in those patients with atrial fibrillation, the most common type of heart rhythm abnormality. It was originally considered to be a good alternative to warfarin, because patients didn’t have to go through regular blood tests, and didn’t require any dietary restrictions.

Recent reports, however, have indicated that the risk of Pradaxa bleeding may be greater than previously believed. All blood-thinning medications carry a risk of bleeding, and the risk with Pradaxa was originally believed to be about the same as that with warfarin, but the FDA recently announced it was looking into post-marketing reports of Pradaxa bleeding, Pradaxa cerebral hemorrhage, and even reports of death from fall linked to Pradaxa.

What is Pradaxa Bleeding?

Pradaxa is a blood-thinning medication that reduces the ability of the blood to clot, which helps prevent a blood clot from blocking an artery and causing a heart attack or stroke. Blood clots also help stop bleeding from injuries, however, so if a patient is taking a blood-thinning medication, he or she has to be particularly cautious when dealing with cuts, wounds, and even falls, which can cause internal bleeding.

Pradaxa already carries a warning about Pradaxa bleeding, but the question is whether or not that warning is adequate. According to recent reports, it may not be, which means that manufacturer Boehringer Ingelheim may be liable for serious injuries suffered by those taking Pradaxa.

What is a Pradaxa Cerebral Hemorrhage?

A Pradaxa cerebral hemorrhage occurs when, as a result of a fall or other injury, the patient suffers uncontrollable bleeding in the brain. Pradaxa works to reduce blood clotting, so the Pradaxa bleeding doesn’t stop.

The Journal of Neurosurgery published a disturbing report in March 2012 of a man who suffered death from fall linked to Pradaxa. The elderly patient was taking Pradaxa for his atrial fibrillation, and suffered a fall like many elderly people do. Those taking warfarin can be quickly treated in instances like these with vitamin K, which reverses the effects of warfarin and allows the blood to clot. Because Pradaxa works differently than warfarin, however, there was no effective antidote to reverse the effects, and doctors were unable to stop the bleeding in time.

The authors of this report noted that as more elderly patients are put on Pradaxa, more may suffer from Pradaxa bleeding and Pradaxa cerebral hemorrhage, stating, “in the event of catastrophic hemorrage no effective reversal agent exists.”

FDA Examines Pradaxa Bleeding

The FDA announced in December 2011 that they were looking into the hundreds of reports received concerning Pradaxa bleeding, to determine whether or not these incidences may be occurring more often than would be expected. The FDA is not the only ones looking into the risks of Pradaxa bleeding, however. New Zealand, as well, following a series of reports of bleeding events, began a similar investigation. Japan has also received reports of over 80 patients suffering from Pradaxa bleeding.

A Pradaxa Lawyer Can Help

If you or a loved one has suffered serious Pradaxa bleeding, you may be eligible for a Pradaxa lawsuit. Contact a Pradaxa lawyer at Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.