A recent investigation reveals that the FDA may have been lenient when approving the newer generation anticoagulant.

This investigative study was conducted by the nonpartisan Project on Government Oversight (POGO), which indicated that the FDA had approved the drug based on poorly designed clinical trials that grossly overlooked patient safety concerns over Pradaxa side effects.

Additionally, Boehringer Ingelheim allegedly ignored its own concerns regarding the lack of precautionary warnings on Pradaxa’s warning label.

Pradaxa is a new-generation anticoagulant that was approved by the FDA in 2010, to be an alternative to Warfarin. Its approval was a landmark in American pharmaceutical history as it was the first anticoagulant to break through into that specific drug market for decades.

It soon outpaced Warfarin in popularity, due to its advertisements stating that it was prescribed in a single dose and worked more efficiently than the older drug.

However, just as quickly as it was released, patients complained of suffering irreversible bleeding events, which required emergency intervention.

This eventually drew so much negative attention that a consolidated litigation movement was established against Boehringer Ingelheim, Pradaxa’s manufacturer.

Furthermore, recent studies have been suggesting that Boehringer Ingelheim and the FDA were too lax in the drug’s release, suggesting that the drug’s risk has always been much higher than its benefits.

Overview of Pradaxa Bleeding Complications

The POGO report begins with the story of a retired social worker named Sidney Denham, who had experienced severe gastrointestinal bleeding from his urinary tract after being prescribed Pradaxa; he had recently undergone prostate surgery.

These internal bleeding injuries had eventually led to his death, in which the doctor reported the cause of death as “uncontrollable hemorrhage from Pradaxa” as a contributing cause.

Dr. Bryan Cotton then started discussing his own experiences in witnessing these Pradaxa side effects in his own patients at the University of Texas Medical Center, with 25 patients needing emergency room visits.

He published his observations in the New England Journal of Medicine in 2011, stating that it is frustrating to inform unsuspecting families that Pradaxa has no bleeding remedy.

In conducting the investigation, eight POGO employees had sorted through thousands of files from court cases and open records requests, for over two years; this was to trace the time line between Pradaxa’s approval and the product liability claims.

The research showed that researchers had removed Pradaxa patients who exhibited early side effects, which significantly effected the results.

Additionally, an FDA review had found that the way the trial was conducted was designed to show that Pradaxa appeared to perform better than Warfarin. Neither Warfarin or Pradaxa patients hadtheir blood tested for thickness, which further skewed the results against Warfarin.

These and other troubling finds made in the POGO report prompted the nonprofit to declare the clinical trial process for Pradaxa “a sausage factory”. These findings were presented in a recent report, claiming that there were significant flaws in almost every stage of the pre-approval process of Pradaxa.

The watchdog group criticized the FDA for allegedly overlooking obvious risks and supporting false advertising claims for Pradaxa. POGO’s report could not have come at a worse time for the FDA, as Congress is currently considering to implement the 21^st Century Cures Act; this would quicken the FDA’s approval process and increase the amount of work for the affect.

Officials from Boehringer Ingelheim had discussed their clinical trials with POGO in 2013, calling the article too biased and misleading towards patients and physicians.

Meanwhile, patients and doctors continue to suffer the ambiguity in the warning label and the injury reports, with many reporting severe internal bleeding injuries. A number of them have filed product liability lawsuits against Boehringer Ingelheim, for failing to warn them against Pradaxa bleeding risks.