This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.
FDA and Pradaxa manufacturer, Boehringer Ingelheim are scrambling to rectify a huge mistake when Pradaxa the FDA agreed to fast-track the drug. Faulty studies and negligent marketing labeled Pradaxa as the safest and most effective blood thinner on the market. Now, nearly 6 years later, there have been 9,000 patient hospitalizations and over 1,000 reported deaths. Finally, the manufacturer releases a reversal agent, Praxbind, to help mitigate the devastating effects caused by Pradaxa.
About Praxbind
Administered by an intravenous injection, Praxbind binds to Pradaxa to neutralize the drug. The FDA said Praxbind underwent three separate clinical trials involving around 300 healthy people. Therefore, Praxbind is safe and effective at neutralizing Pradaxa. Where are the multiple studies involving those not in optimal health? The majority of Pradaxa users at risk for uncontrollable bleeding are the elderly. If researchers don’t include them in the study, how can we truly know this reversal agent is, in fact, safe and effective as the FDA claims?
A 2014 study by JAMA: Internal Medicine reported that Pradaxa is associated with a 30% greater risk of a bleeding event, a 58% greater risk of major bleeding, and 85% greater risk of gastrointestinal bleeding. Those are risky statistics to gamble on a fast-tracked reversal agent. The FDA fast-tracked Pradaxa too and that is one of the reasons thousands have lost their lives. The FDA lists common side effects as a headache, hypokalemia, confusion, fever, pneumonia, and constipation. What about the glaring side effect of death if it doesn’t work? Are you willing to bet your life on Praxbind to stop Pradaxa?
Therefore, the fact remains that Pradaxa was pushed onto the market without appropriate studies and lacking a reversal agent that was studied for a long period of time with multiple participants of all ages and health backgrounds. Bottom line: be wary.
If you or a loved one suffered uncontrollable bleeding from taking Pradaxa, contact the dedicated attorneys at The Michael Brady Lynch Firm, today at 877-513-9517.
