Response to media coverage on CTV National News
Burlington, Ontario, April 22 – At Boehringer Ingelheim, patient safety is always our first priority. We are vigorously defending Pradaxa® in every lawsuit. This important medication is approved in more than 100 countries. Pradaxa® reduces the risk of stroke, which is potentially debilitating and fatal in patients who suffer from the irregular heart rhythm condition known as atrial fibrillation.
Results from one of the largest international stroke prevention research programs involving 18,000 patients, demonstrated the safety and efficacy of Pradaxa® and its superior benefits when compared to the leading competing blood thinner product.
We are confident the evidence will show we acted appropriately and responsibly in our research, development and marketing of this important medication.
The efficacy and safety of Pradaxa® are proven and well-documented in one of the largest international stroke prevention research programs involving 18,000 patients, demonstrating the superior benefits the treatment offers to people with irregular heart rhythms when compared to the leading competing blood thinner product.
All blood thinning medications carry an increased risk of bleeding, but for those with irregular heart rhythm, this must be balanced against the risk of a stroke. Patients should always consult with their doctor regarding the use of medications and should not stop taking this or any other medication without first talking to their doctor. Stopping use of blood thinning medication puts a patient with irregular heart rhythm at increased risk of stroke.
We provide clear and accurate information to healthcare professionals regarding the benefits and safety profile of Pradaxa® through multiple resources, including the Health Canada-approved product monograph. In addition, we provide clear and accurate information to patients including the Health Canada-approved leaflet in each package of Pradaxa®.
In the rare event of a major bleed, a number of established measures are available to reverse the blood thinning effect of Pradaxa® or to manage bleeding during an emergency situation. These measures are described in the Health Canada-approved product label, and are almost identical for all blood thinning treatments including warfarin and novel oral anticoagulants (NOACs). Pradaxa® has the additional option to be removed via dialysis.
There are four statements of claim filed in Canada each naming as plaintiff a single patient on Pradaxa® but seeking to represent a broader class of individuals. These cases are all at an early procedural stage; none has been certified by the court which is a necessary step for a class action to proceed.
We are confident the evidence will show we acted appropriately and responsibly in our research, development and marketing of this important medication.