Report Reveals Thousands of Pradaxa Complaints, 582 Deaths

The manufacturers of Pradaxa, who are facing hundreds of product liability lawsuits related to Pradaxa injuries, have received additional bad news. A new study has revealed that the drug had more adverse events reported to the U.S. Food and Drug Administration (FDA) than any other drug in 2012.

Pradaxa is an anticoagulant or blood thinner  medication designed to interfere with the process of blood clotting. When blood clots from inside the body, they can cause a host of problems, including strokes and certain types of heart attacks. Anticoagulants like Pradaxa are designed to reduce these problems by preventing and breaking down blood clots. However, blood thinners can also make it much easier for patients to suffer from uncontrollable bleeding from minor injuries. Certain drugs can reverse the effects of older blood thinner medications in the event of such an emergency, but Pradaxa has no known reversal agent.

The Institute for Safe Medicine Practices (ISMP), a nonprofit watchdog organization, compiled a report based on complications caused by Pradaxa side effects that were reported to the FDA’s Adverse Events Reporting System (AERS).  Their report states that over 3,292 serious events were reported through AERS, including 582 deaths related to Pradaxa side effects.

The report ranked various drugs in terms of the number of serious events reported to AERS. Another drug, Xarleto, an anticoagulant similar to Pradaxa, ranked tenth on the same list. AERS received 2,081 reports of serious complications, including 151 deaths. For comparison, Warfarin (also sold as Coumadin) had only 861 serious events reported, including 56 deaths. Warfarin is an older blood thinning medication with a known reversal agent. While anticoagulants do carry some risk, the ISMP report indicates that new blood thinners like Pradaxa and Xarelto may be more dangerous. The most commonly-reported complication for anticoagulants was uncontrolled bleeding.

The finding contrasts with statements by the FDA and Boehringer Ingelheim, citing a number of studies indicating that Pradaxa has about the same incidence of uncontrolled bleeding as Warfarin. It says nothing of the fact that Pradaxa has no reversal agent. Up to this point the FDA has been cautious about linking Pradaxa to an increased risk of uncontrollable bleeding. This could simply be a matter of needing more evidence before making statements or policy on the matter.

Hundreds of Pradaxa lawsuits have been filed by Pradaxa bleeding victims and their survivors, alleging that the drug manufacturers knew the drug was dangerous but concealed this risk from the public. These lawsuits seek reimbursement for medical costs, final expenses, and lost income potential.

If you or a loved one used Pradaxa and suffered from uncontrollable bleeding, you’ve almost certainly been through a trying ordeal. When facing sudden medical emergencies, many people feel overwhelemed, or even depressed. But you need to remember that regardless of the challenges you are facing, you still have rights, and there are steps that you can take to regain a measure of control over your situation. You can start by visiting the Pradaxa Internal Bleeding Class Action Lawsuit Investigation. Here, you can enter information about your situation for a legal review by a trained expert with  a background in this type of litigation.