Pradaxa studies raise concerns about major bleeding events, other complications from bloodthinner

by Michael Heygood

New data from a pair of studies about the side effects of Pradaxa have raised concerns about the dangers of the blood thinning drug. Studies conducted by the Food and Drug Administration and the manufacturer of Pradaxa point to a link between the bloodthinner and a risk of severe gastrointestinal bleeding or other major bleeding events.

Pradaxa (dabigatran) was approved by the FDA in 2010 to help prevent strokes in patients with a heart-rhythm disorder known as atrial fibrillation. The drug was the first FDA approved alternative to warfarin, a drug used to prevent strokes caused by blood clots for more than five decades.

Pradaxa Linked to Major Bleeding Events in New Study Data

In a study recently conducted by the FDA, researchers warned that patients taking Pradaxa were more likely to suffer major gastrointestinal bleeding than patients who were prescribed another bloodthinner, warfarin. The FDA study was based on an analysis conducted by the agency of 134,000 Medicare patients age 65 or older. The new study relied on a much larger and older group of patients than what had been used in previous studies of the drug and used a more sophisticated method of analysis than the one which had been applied during the agency’s initial review of the drug.

A new analysis conducted by Boehringer Ingelheim GmbH—the manufacturer of Pradaxa—uncovered 16 major bleeding events that had gone unreported in a previous study of the drug. Additional bleeding events with Pradaxa were reported among patients who took both the 110-milligram dose and the 150-milligram dose of the drug during the study.

These new findings were the second time that Boehringer has been forced to revise the number of major complications associated with Pradaxa in the study that was used to secure FDA approval for the drug. In November 2010, the company revealed that 80 cases of major complications had gone unreported in its own studies of the drug, including cases involving blood clots or major bleeding incidents, four cases of heart attack, and one case involving stroke.

Lawsuits Filed Over Complications Linked to Praxada

Boehringer is facing more than 2,000 lawsuits filed on behalf of patients who suffered major bleeding events or other complications from the use of Pradaxa. Many of these cases involve complications that could not be treated because unlike warfarin, there is no antidote that can reverse the anti-clotting effects of Pradaxa once it has been administered. More than 1,400 patients have bled to death while taking Pradaxa as of October 2013, according to a deposition by a Boehringer executive that was recently unsealed as part of the lawsuits against the company.

If you or a loved one have suffered a major bleeding event or other serious complications linked to the use of Pradaxa, you have legal rights. The first step to ensuring that your rights and those of your loved ones are fully protected is to secure the services of experienced legal counsel who can advise you on your case.

The lawyers at Heygood, Orr & Pearson have made it a career priority to ensure that the manufacturers of dangerous drugs or medical devices are held accountable for the injuries caused by their products. Our attorneys have taken on some of the largest companies in the world in cases involving products such as the fentanyl pain patch, defective hip implants or knee implants, Yaz, Actos, Avandia, and Accutane.

For a free legal consultation about your case and to learn more about filing a Pradaxa lawsuit, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation page.

by Michael Heygood

Michael Heygood is a licensed attorney and partner at HO&P who focuses on insurance and corporate litigation, and other civil arenas. Michael has been named multiple times to the Super Lawyers List.