Pradaxa: A Case Study In A Broken FDA Approval System

The FDA Failed Pradaxa Users

This is attorney Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.

The deeper one delves into the tragic history of the prescription blood thinner Pradaxa, more troubling facts emerge concerning our drug approval process. And both the FDA and Pradaxa manufacturer Boehringer Ingelheim are to blame.

A recent scathing report published from Project on Government Oversight (POGO) detailed troubling FDA oversights and a dangerously lax approach when it came to approving Pradaxa. Some of the troubling issues uncovered were dismal clinical trial standards for drug approval, faulty patient warnings, and false advertising claims. The most horrifying fact unearth is the FDA approved the drug despite the absence of an antidote, which would be used to stop patients from bleeding uncontrollably when hemorrhaging. Pradaxa’s warning label does not even tell patients about the major or fatal bleeding that can occur when taking the blood thinner.

Pradaxa went through just one clinical trial before being approved by the FDA. In the lone trial report, the FDA deleted a section that POGO acquired through the Freedom of Information Act that said patients using warfarin didn’t need to switch to Pradaxa. Initially, the FDA refused to allow advertisers to claim the drug was better than warfarin because of this result. Without any explanation, the FDA revoked the refusal, dropped this finding from the initial report and allowed the manufacturer, Boehringer Ingelheim to make the claim.

Data deception and manipulation were also rampant. The FDA allowed Boehringer Ingelheim to make a second misleading claim that it “reduced stroke risk 35% more than warfarin”. When asked about the misleading fact, the FDA made the manufacturer clarify “That means that in a large clinical study, 3.4% of patients taking warfarin had a stroke compared to 2.2% of patients taking Pradaxa.” In other words, the difference between Pradaxa and warfarin is only 1.2% — very different from the previous claim of 35%.

Not surprisingly, when the medication faced the FDA Advisory Committee for FDA approval, it did not receive a single negative vote. Financial disclosures later showed that two of the committee members had a financial relationship with the manufacturer. Members received payments between $75,000 and $135,000, and others even chaired other clinical trials run by Boehringer Ingelheim.

The FDA needs to act for the public instead of abetting the interest of large pharmaceutical companies like Boehringer Ingelheim. If the FDA had initially done this, thousands of users may have been spared the devastating effects of this drug. If you or a loved one have been a victim of the uncontrollable bleeding caused by Pradaxa, please call us at 877-513-9517.

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