Home » Drug Warnings » Anticoagulant Pradaxa – FDA Safety Announcement

Anticoagulant Pradaxa – FDA Safety Announcement

photo of PradaxaIntroduced in October 2010, the purpose of the blood thinner Pradaxa is to reduce the risk of blood clots and stroke in patients with atrial fibrillation. According to a recent article by the Institute for Safe Medication Practices (ISMP0), the Food and Drug Administration has been notified of over 900 reports that link Pradaxa to serious medical complications. These “adverse events” include 120 deaths, 25 cases of permanent disability, and 505 cases of hemorrhage. The events involving hemorrhage predominantly occurred among patients with a median age of 80 years. These reports raise questions concerning safe doses and monitoring standards when Pradaxa is prescribed for elderly patients. Although bleeding has long been recognized as a possible complication of anticoagulant medications, the FDA is re-evaluating Pradaxa in light of the number of adverse events to determine whether occurrences of bleeding are excessive.
“At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label… Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke.” Click here to read the full text of the FDA Safety Announcement.


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