Pradaxa is known as an anti-coagulant, or blood thinner, and may be used in patients who have atrial fibrillation or who have heart valve problems. These people are at a higher risk of having a stroke. The makers of Pradaxa- Boehringer Ingleheim- claim that this drug is 35% more effective for reducing risks of having a stroke than the traditional medicine, warfarin. However, they fail to bring attention to the fact that Pradaxa has been linked to bleeding and death worldwide.
Boehringer Ingelheim has released the following data from March 2008 through October 31, 2011; Pradaxa related bleeding death cases: 14 in Japan, 21 in Europe, and 225 others in various countries around the world. There are no known statistics for these types of cases in the U.S. just yet.
Pradaxa is under investigation by health officials in the U.S. and other countries.
However, there has not been a recall issued at the time of writing this. Persons who have taken the drug and have experienced serious bleeding issues may be eligible to participate in a Pradaxa lawsuit. Pradaxa has been linked to:
Bleeding can be a common side effect among this type of medication, but with Pradaxa the risks appear to be much more serious.
In October 2010, Pradaxa was approved by the FDA in a class of drugs called direct thrombonin inhibitors. These types of medications limit a certain enzyme that is important to the clotting process.
The kidneys excrete Pradaxa from the body; therefore high levels of it can stay in the bodies circulatory system. It’s believed that the higher the levels of Pradaxa in the body, the higher the risk of serious internal bleeding. The data taken from a clinical trial conducted by RE-LY indicated that about 16.4% of people who take Pradaxa will experience some sort of internal bleeding.
The FDA released a statement in December of 2011 stating that they believe Pradaxa has important health benefits when used as directed, but the reports of bleeding still under investigation. Patients using the medication were warned not to stop taking it without consulting their doctors first.
In October 2011, The European Medicines Agency warned doctors about prescribing the drug to patients 75 or older or those with renal problems. If the patient has renal impairment, the kidneys should be checked every year.
After 81 of 64,000 elderly patients on Pradaxa experienced excessive bleeding in August 2011, Japanese authorities asked the maker of the drug to issue a warning. Of those 81 elderly patients, 14 died.
If you or someone you know has taken Pradaxa and has had serious bleeding you should consult with one of our injury attorneys right away. We offer everyone that’s suffered from excessive bleeding, while on Pradaxa, a free legal consultation. Call 1-843-839-3377 and schedule your consultation with one of our lawyers today.