Non-profit group criticizes FDA’s Pradaxa safety analysis

by Heygood Orr and Pearson

A non-profit organization formed by the Food and Drug Administration and other health groups has criticized the agency’s safety analysis of the blood thinning drug Pradaxa. According to data released by the Observational Medical Outcomes Project (OMOP), the FDA’s analysis of the risk of bleeding risk caused by Pradaxa may have been flawed, causing the agency to underestimate the health risks of the drug.

The OMOP presented data at a symposium in June 2012 which called into question the method that the FDA used for comparing the safety of Pradaxa to other blood thinners, such as warfarin. The FDA conducted its analysis after Pradaxa was linked to more than 500 deaths and more cases of side effects than any other drug.

While the FDA initially concluded that Pradaxa was not any more dangerous than warfarin or other blood thinning medications, the OMOP’s analysis found that the agency may have relied on an inaccurate statistical method in assessing the safety of Pradaxa. This may have led the FDA to underestimate the side effects of Pradaxa.

In addition, the OMOP found that the FDA may have failed to take into account the fact that Pradaxa does not have an antidote to prevent clotting, unlike other blood thinners. Because of this, patients who develop severe bleeding while being treated with Pradaxa are not able to receive medications to immediately stop excessive bleeding caused by the drug. The OMOP says that this could account for the high number of hospitalizations and deaths seen among Pradaxa users.

Heygood, Orr & Pearson currently represents families who lost a loved one who was using Pradaxa, and we have represented dozens of other families in lawsuits against drug companies. If a loved one died while using Pradaxa, you may have valuable legal rights. To receive a free legal consultation and find out if you are eligible to file a case, please call our toll-free hotline at 1-877-446-9001, or by filling out our free case evaluation form located on this page.