The Pradaxa Problem: A History

As the first new blood-thinner to be approved by the FDA in 50 years, Pradaxa was expected to replace warfarin (Coumadin)—the longtime standard of stroke-prevention care—as the U.S. scientific and medical communities’ blood-thinner of choice. In a little more than a year after the FDA approved Pradaxa in 2010, however, the agency announced that reports of serious bleeding in patients taking the drug had inspired it to investigate whether Pradaxa posed more significant bleeding risks than initial clinical trials had led the agency to believe.

Soon after the FDA announced that it would be further investigating Pradaxa bleeding risks, researchers uncovered more evidence of the bleeding risks posed by the drug, and the media took notice, publishing stories about Pradaxa bleeding risks and Pradaxa victims.

Thanks to this publicity, Pradaxa victims have come to learn that they’re not alone, and many of them have gotten in touch with us, the Rottenstein Law Group, to assess whether they have a case against the manufacturers of Pradaxa.

We are now filing individual lawsuits on behalf of many of the patients who have reached out to us claiming they were hurt by Pradaxa.

Here’s timeline of events leading up to the Pradaxa lawsuits currently being filed:

October 2010
FDA approves Pradaxa capsules for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation). Approval is based largely on a clinical trial conducted on 18,000 patients, some of whom were on Pradaxa and some of whom were on warfarin. In that trial, a similar number of patients in each group suffered major bleeding events.

October 2010 — August 2011
Approximately 1.1 million Pradaxa prescriptions are dispensed and approximately 371,000 patients receive Pradaxa prescriptions from U.S. outpatient retail pharmacies.

December 2011
FDA announces plans to look into the risk of bleeding events posed by Pradaxa. FDA spokesperson says the agency isn’t prepared to disclose how many reports of serious bleeding events have been received because “they’re still being reviewed,” according to the Jan. 2012 issue of The Hospitalist.

March 2012
Online edition of the Journal of Neurosurgery reports on an elderly male Pradaxa patient’s death, which was caused by a massive brain hemorrhage after a routine fall.

May 4, 2012
At a scientific symposium in Chicago, researchers present results of a study showing that complications requiring drug discontinuation occurred more frequently with Pradaxa than with warfarin (brand name: Coumadin), a much older blood thinner.

May 6, 2012
The study results that were presented at the Chicago symposium on May 4, 2012, are published on the prestigious heart news site the


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