In a Pradaxa study conducted by the University of North Carolina, researchers were surprised to find that the next generation anticoagulant drug may contribute to elevated risk and increased severity of viral infections, including myocarditis, an inflammation of the heart that has resulted in death in children and young adults, and influenza.
Pradaxa was approved by the FDA to treat non-valvular atrial fibrillation, which is becoming increasingly common and is associated with an elevated risk of the patient developing life threatening blood clots. The drug minimizes clots by thinning the blood. Patients who use the drug may become more susceptible to viral infections because the drug blocks the activity of thrombin. Thrombin is an enzyme that plays an important role in the way in which blood clots. Blocking throbin’s activity reduces an aspect of the immune system’s response to viral infection.
How Clotting Works to Fight Infection
The several teams that worked on the study, including Charité – Universitätsmedizin in Berlin, Germany and the Mackman Group, did not anticipate that they would discover the increased viral infection risk that appears to be associated with Pradaxa. The finding was made as the group how the body’s cells respond to viruses. Although other studies reported findings which suggested that fibrin, a clotting protein that is formed by thrombin, is responsible for activating immune cells which attack bacteria, viruses, and other pathogens and digests them.
However, the researchers found that this belief is not accurate, concluding that the antiviral mechanism in the clotting system is linked directly to thrombin. Mackman explained that thrombin works by triggering the immune response by activating PAR-1,a type of receptor cell. The team studied the immune response by deactivating PAR-1 in mice. When the mice were infected with a myocarditis-causing virus, the team observed increased impairment of the heart function in the mice along with more viral buildup. The mice’s immune system also had a slower response after infection.
Applying the Study to Pradaxa
After discovering the impaired heart function, increased viral buildup, and slowed immune response in mice in which PAR-1 had been deactivated, researchers gave Pradaxa to normal mice. The mice that had been given Pradaxa exhibited the same symptoms as those in which the researchers had deactivated PAR-1. Macklan concluded that while Pradaxa may have significant lifesaving results when used to treat as an anticoagulant, the drug may also negatively impact other areas of health.
The study’s findings have led to the recognition of yet another possible risk patients must consider when taking Pradaxa. Approximately 4,000 complaints were filed with the FDA in 2011 citing serious adverse events, and 550 reports which cited deaths that were linked to the use of Pradaxa were also received. As a result, over 250 Pradaxa lawsuits were consolidated and are now pending in the U.S. District Court for the Southern District of Illinois. The team plans for its next study to examine warfarin. Warfarin is has been prescribed more than any other blood thinner for decades.
Authored By: Renee Simmons. Renee is a journalist/blogger who contributes new legal information across different websites and organizations.
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