Investigation Says FDA was "Lax" in BI's Pradaxa Approval

Oct 15, 2015

According to an independent investigationof the FDA’s review process, the agency approved Boehringer Ingelheim's blood thinner on the basis of a single, poorly designed clinical trial that overlooked safety concerns.

The investigation, conducted by the nonpartisan Project on Government Oversight (POGO), highlights flaws at virtually every stage of the FDA’s approval process for Pradaxa.

According to an article reported by IBT, POGO's investigation of thousands of pages of files obtained through court cases showed that Pradaxa was approved on the merits of a single clinical trial that was not blinded -- meaning researchers knew which patients were taking Pradaxa versus warfarin. An FDA review cited in the report found that researchers further skewed results by removing patients who were on Pradaxa from the clinical trial if they suffered early side effects with the potential to become serious.

While the FDA originally urged Boehringer Ingelheim to use a blinded trial, the agency accepted the company’s unblinded results.

First approved in 2010, controversy has surrrounded Pradaxa.

In February 2014, Boehringer Ingelheim reported that it was facing more than 4,000 U.S. lawsuits over claims its blockbuster drug Pradaxa, the first in a new class of stroke prevention pills, caused severe and fatal bleeding.

Later that month, media sources reported that "unsealed court filings" showed that Boehringer failed to disclose a data analysis to the FDA that indicated a higher death rate due to fatal bleeding from anticoagulant Pradaxa.

The FDA then launched an inquiry into Pradaxa's safety which concluded that - based on a review of 134,000 patients - Pradaxa has a "favorable benefit to risk profile" and no changes to its labeling were warranted.

Read the International Business Times article