Manufactured by Boehringer Ingelheim, Pradaxa is designed and marketed to act as an oral anticoagulant or blood thinner. While on Pradaxa, however, the patient has no convenient way of assessing how much anticoagulation has occurred, and he or she does not know if the blood is in its therapeutic range, or if it is too thin or at risk of clots. Should the drug go too far, there is no way to easily reverse the effect and thinning of the blood, other than emergency dialysis, which is unsafe for those in an unstable condition, such as a large intracranial hemorrhage.
Also, over-thinning of the blood can lead to life-threatening bleeding complications. This can include internal bleeding or complications following a simple fall or bump. Additionally, the complications can cause hemorrhagic stroke resulting from a ruptured blood vessel in the brain.
Pradaxa complications are grave and can lead to death. Within three months on the market, Pradaxa has already been linked to more than 300 complications. In 2011 alone, the drug was reported to cause 541 deaths. Other reports included thousands of cases of hemorrhage, kidney failure and stroke. FDA investigations and tests into the matter were alarming.
Boehringer Ingelheim failed to warn doctors and patients of the severe risks associated with the drug, including uncontrollable bleeding. It also did not provide means of reversing the effects of the drug in case of emergency. This defective design cost hundreds of patients their lives.
More Than $650 Million In Settlements Already Paid
In 2014, Boehringer Ingelheim settled over 400 lawsuits for $650 million. In 2015, an antidote was released, Praxbind, which may help lower the risks of dangerous side effects. More prominent warning labels have also been added to Pradaxa prescriptions.
Unfortunately, not everyone who has been harmed by Pradaxa was included in the initial settlements, and many lawsuits are still being filed for the danger Pradaxa continues to pose to families.