FDA to Conduct Pradaxa Study

The US Food and Drug Administration (FDA) has announced a plan to conduct a safety assessment of the blood thinner Pradaxa (dabigatran).  The FDA describes the assessment as “a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin.”

The study will “assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of dabigatran and warfarin for patients with atrial fibrillation using data from the FDA Mini-Sentinel Distributed Database (MSDD).”

According to the FDA, Mini-Sentinel is a part of the FDA sentinel surveillance system that uses electronic healthcare data from nearly 100 million patients.

Pradaxa manufacturer Boehringer Ingelheim issued a statement following the news of the study announcement saying, “[the] fact that FDA requests and receives data on a particular product through Mini-Sentinel does not necessarily mean there is a safety issue with the product.”

Studies done in other countries have showed that individuals using Pradaxa have roughly a 33 percent higher risk for fatal health risks as compared to individuals using the blood thinner warfarin.

If you have used Pradaxa and have experienced any adverse side effects our defective drug attorneys are on the patients’ side. Contact our injury lawyers toll free at (888) 841-9623 to discuss the Pradaxa lawsuit. Our firm offers confidential, no obligation consultations.

Zoll & Kranz, LLC – Pradaxa attorneys