Investigating the claims against Pradaxa
The lawyers of O’Connor, Acciani & Levy Co., LPA are currently investigating the claims of serious injury and death involving the drug 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 over 2 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 which 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 won’t need as many lab tests as patients on Coumadin, making it more convenient to use. Sales of Pradaxa are expected to reach $603 million this year.
The Clinical Trial
A close look at 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; 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
In an earlier post we warned that the FDA initiated an investigation into Pradaxa in December 2011. This investigation is 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 in January of this year, some still argue that the label is still inadequate.
If you or a loved one has experienced one of the dangerous bleeding events associated with the use of the drug Pradaxa, then call O’Connor, Acciani & Levy for a free consultation.