Response to Recent Media Coverage of Pradaxa® (dabigatran etexilate mesylate)
Burlington, Ontario, March 21, 2014 - Recent media coverage has used very limited and specifically selected fragments of robust internal discussions to inaccurately and incompletely characterizeBoehringer Ingelheim and Pradaxa® (dabigatran etexilate mesylate) within the context of a current US-multi-district litigation regarding Pradaxa®.
A highly-respected Canadian research institution has also been a target of this recent media coverage. Boehringer Ingelheim and our research partners are completely confident in the integrity and the validity of all our research studies related to Pradaxa®.
We are deeply concerned that misleading and imbalanced media coverage could compromise the health and safety of patients taking a medication like Pradaxa® to reduce their risk of stroke when used as directed.
Patients should not stop taking their anticoagulant medication or any other medication without first talking to their health care providers. Discontinuing anticoagulation therapy puts a patient at increased risk of stroke.
At Boehringer Ingelheim, patient safety is our top priority. We are confident the evidence will show that Boehringer Ingelheim acted appropriately and responsibly in our research, development and marketing of this important medication. Pradaxa® is an important treatment currently approved in 100 countries after Health Authorities’ review of the clinical trial data and deemed to be safe and effective when used as directed in the product monograph.
We fully intend to defend this important medication against each and every product liability case. We are confident that the evidence reviewed during the litigation process will show that Boehringer Ingelheim acted appropriately and responsibly in our research, development and marketing of this important medication.
We are not able to comment on the Pradaxa® litigation proceedings taking place in the United States, nor allegations related to our research partners. The cases in question fall under a different legal jurisdiction than our own, and relate to a different product monograph and dosing than what is currently approved for use in Canada.
Boehringer Ingelheim stands behind Pradaxa®. We are confident the facts will show that Boehringer Ingelheim and its employees acted appropriately and responsibly.
Patients and physicians with questions should call: 1 (800) 263-5103 Ext. 84633