The Hidden Truth Behind Pradaxa

Pradaxa was approved by the FDA in October 2010. Pradaxa (Dabigatran) is marketed by Boehringer Ingelheim Pharmaceuticals, Inc. Pradaxa is intended to reduce the risk of strokes and blood clots in people with atrial fibrillation. Pradaxa is in a class of drugs commonly known as ‘blood thinners.” Pradaxa prevents blood clots from forming by inhibiting the effects of thrombin, which is responsible for clotting. Boehringer Ingelheim Pharmaceuticals markets Pradaxa as easier to dose, requiring less monitoring, and more effective at preventing clots compared to the other drug in its class, Warfarin (Coumadin).

Pradaxa causes bleeding, which cannot be stopped with vitamin K, unlike Warfarin. With no antidote, Pradaxa bleeding can be fatal.

Atrial Fibrillation

Atrial fibrillation is the most common heart rhythm condition. Patients with atrial fibrillation (a fib) often require blood-thinners. Warfarin is a commonly used blood-thinner in patients with a fib. Pradaxa is the first FDA approved alternative to Warfarin. Unfortunately, the adverse event reports have been staggering. Boehringer confirmed that as of November 2010, at least 260 fatal bleeding events occurred in patients taking Pradaxa.

We believe the absence of an antidote is the cause of the significant number of bleeding deaths. In light of the data, the FDA required Boehringer to change the Pradaxa label to warn of the lack of a reversible agent. The failure to include this fact in the original label was done in reckless disregard for the safety of Pradaxa patients.

Pradaxa and FDA Reviewing

Pradaxa is under close FDA scrutiny, and FDA is currently scrutinizing the reports of Pradaxa bleeding deaths. Boehringer is telling the world that it is working to find an antidote. We believe until an antidote is found, this dangerous drug need to be removed from the market. If an antidote is ever found and this dangerous drug is permitted to remain on the market, it must contain a black box warning to avoid a public health crisis.

Are You a Victim of Pradaxa?

The Levensten Law Firm is lead counsel for many individuals who suffered serious bleeding events while taking Pradaxa. .

If you believe you are a victim of Pradaxa, contact our law firm for a free consultation.