The Cincinnati dangerous drugs lawyers of O’Connor, Acciani & Levy are currently investigating claims of serious bleeding events and death involving the prescription blood thinner Pradaxa.
Have you or someone that you love, suffered an injury or serious side effect after taking Pradaxa?
Contact the law offices of O’Connor, Acciani and Levy today for a free consultation to determine if you may be entilted to file a Pradaxa lawsuit seeking compensation for medical expenses, lost wages and other damages.
WHAT IS PRADAXA?
Pradaxa is a prescription blood thinner manufactured by the drug company Boehringer Ingelheim Pharmaceuticals. Pradaxa was approved by the FDA in October 2010.
Doctors prescribe Pradaxa to prevent stroke in patients with non-valvular atrial fibrillation (A-fib), a disease that affects more than two million people in the United States. High blood pressure, obesity, diabetes, thyroid problems, lung cancer and alcoholism are all risk factors for A-fib. If A-fib is left untreated, the patient has an increased risk of stroke.
Pradaxa is the first drug presented as an alternative to Coumadin, a blood thinner that has been on the market for almost 60 years. The drug has been marketed to doctors and consumers as having fewer drug interactions than Coumadin. Boehringer Ingelheim also claims that patients on Pradaxa do not need as many lab tests as patients on Coumadin, making it more convenient to use.
THE CLINICAL TRIAL
A study that review the clinical trial sponsored by Boehringer Ingelheim, seems to suggest that Pradaxa may have a higher rate of major gastrointestinal bleeds than Coumadin. The study also suggested that Pradaxa may have a higher risk of all types of bleeding for patients over 75.
Another critical difference between Coumadin and Pradaxa is that there is currently no reversal agent for Pradaxa. A reversal agent is a drug used to counter the effects of another drug. In the case of Coumadin, there is a known reversal agent available, which allows doctors to stop any major bleeding events experienced while on the drug.
Pradaxa, on the other hand, has none. That means that doctors have very little they can do to reverse the effects if a patient is experiencing a major bleeding event. This may explain the increasing number of fatal bleeds associated with Pradaxa use since it was released.
THE FDA INVESTIGATION
The U.S. Food and Drug Administration (FDA) initiated an investigation into Pradaxa in December 2011. This investigation was meant to determine whether bleeding events associated with the drug occur more often than should be expected.
The biggest question for consumers is whether the makers of Pradaxa failed to adequately warn the public about the risk of uncontrollable bleeding associated with the drug. When the drug was first released, information about Pradaxa having no known reversal agent was buried in the middle of the label and was outside the warnings and precautions section. Though the label was updated, some still argue that the label is still inadequate.
Because there was not an adequate warning of the risks associated with this medication, injury victims may be entilted to file a Pradaxa lawsuit seeking compensation.
LEARN ABOUT FILING A PRADAXA LAWSUIT TODAY
If you or a loved one has experienced one of the dangerous bleeding events associated with the use of the drug Pradaxa, contact O’Connor, Acciani & Levy today for a free consultation to learn about your right to file a Pradaxa lawsuit.
For more than three decades we have been fighting for the rights of injury victims in Ohio and Northern Kentucky and are ready to help you today.
We proudly offer Pradaxa injury victims 100% FREE case reviews and we only get paid when we win.