Patients taking the medication Pradaxa (dabigatran) may be surprised to learn that the drug was approved by the U.S. Food and Drug Administration (FDA) through an expedited review process, meaning that it did not go through the same safety precautions as other medications. According to a report published last month in the Journal of the American Medical Association, the side effects from drugs like Pradaxa are a primary example of why expedited review can put patients at risk.
Pradaxa was approved in 2010 to prevent blood clot stroke and heart attack in patients who have atrial fibrillation, a condition that causes an abnormal heart beat. Although it was initially hailed as a warfarin replacement, reports indicate that the medication is associated with severe side effects, including uncontrollable bleeding and death. Currently, there is a market competing to replace warfarin, which is an older anticoagulant that requires regular blood testing and dietary changes. Newer anticoagulants like Pradaxa do not require these lifestyle changes, but they may also lead to irreversible bleeding because there is no antidote. This means that a minor injury, such a ground-level fall, can have fatal consequences for patients taking Pradaxa.