Setting record straight on Pradaxa
Boehringer Ingelheim (BI) wants to set the record straight following misleading statements that the British Medical Journal (BMJ) published today regarding Pradaxa (dabigatran etexilate mesylate), as we are concerned that the reporting might put patients at risk of stopping their important stroke-preventing medication.
On May 13, 2014, in one of the largest real-world analyses of its kind, the Food and Drugs Administration (FDA) reaffirmed Pradaxa’s positive efficacy-safety profile when it issued results from this study in clinical practice. This included more than 134,000 patients, who were 65 years or older and were not monitored.
Many of the allegations made by BMJ were reported months ago in the media and have been previously addressed in full by BI. Our company has provided medicines regulators with the complete data set and analyses of clinical evidence demonstrating the efficacy and safety profile of Pradaxa, and the FDA and European Medicines Agency have affirmed the conclusions of the pivotal clinical trial (RE-LY) and state that Pradaxa provides an important health benefit when used as directed.
BMJ did not put this information into proper context, as their articles do not adequately communicate how crucial it is for patients with atrial fibrillation at risk of stroke to protect themselves from a potentially devastating or even fatal stroke.
Contrary to the BMJ’s accusation that BI withheld analyses RE-LY already showed Pradaxa to be a major step for improving stroke prevention versus standard of care. In 2012, our scientists performed preliminary, exploratory simulations to better understand whether dose adjustments based on plasma concentrations might even further improve the efficacy and safety profile of Pradaxa. Because the simulations did not offer reliable predictions of actual patient outcomes, they were not provided to regulators. However, the data that was used for the simulations had already been provided to regulatory authorities according to local regulatory obligations which allows them to conduct their own analyses. The totality of scientific evidence does not support dosing decisions for PRADAXA based solely on blood levels. The research shows that individual patient characteristics, such as age, kidney function and certain medications, are critical factors in contributing to the risk of bleeding.
BMJ also did not include the information that an FDA director authored an article describing atrial fibrillation, the important role of anticoagulation and novel oral anticoagulants (NOACs) like Pradaxa, rationale behind why the NOACs were approved without an antidote and how the FDA conducts its post-marketing surveillance on all NOACs. The FDA director specifically stated that Pradaxa provides an important health benefit when used as directed. We are deeply concerned that articles like the BMJ’s reports could compromise the health and safety of people who currently benefit from Pradaxa. As with any anticoagulant, there needs to be a balanced consideration of stroke risk reduction and bleeding risk. Patients should not stop taking their anticoagulant medication without first talking to their health care providers.
Discontinuing anticoagulation therapy puts a patient at increased risk of stroke.
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