FDA Study Misses Main Issue Raised in Pradaxa Bleeding Lawsuits

FDA Study Misses Main Issue Raised in Pradaxa Bleeding Lawsuits

By Andrea Gressman

The FDA recently provided new information with regards a recent study that compared Pradaxa with other similar drugs. The purpose of the study was to determine if internal bleeding occurred more frequently with Pradaxa than the other medications that are used for the same purpose that Pradaxa is used for. The new study results showed that when patients used Pradaxa they did not develop internal bleeding side effects any more than the other medications that were included in the study. However, that has never been the issue when it comes to the potentially fatal side effects linked to Pradaxa and the number of Pradaxa lawsuits that have been filed as a result.

The issue has always been, and continues to be, that with Pradaxa there is no antidote to stop the internal bleeding once it starts. The Pradaxa lawsuits repeatedly use this as one of their main issues. The fact remains that the drug manufacturer released Pradaxa onto the market without having a treatment option in place stop Pradaxa internal bleeding and many Pradaxa lawsuits claim that the drug manufacturer actually knew about these Pradaxa side effects and released the drug onto the market anyway.

Despite the fact that the FDA completely missed the mark on these critical issues, this study should not negatively affect any of the current or future Pradaxa lawsuits in any way. Because, again, this recent study doesn’t even come close to addressing the main issue that those who have filed a Pradaxa lawsuit have with the drug in the first place.