Drug manufacturer Boehringer Ingelheim Pharmaceuticals withheld critical evidence of Pradaxa bleeding events from the FDA, according to a new investigative report conducted by the British Medical Journal. Without access to the undisclosed drug risk information, the FDA approved the use of Pradaxa in 2010 on the grounds that it did not require monitoring.

Pradaxa is a bestselling prescription medication, intended to reduce the risks of stroke in patients with atrial fibrillation, a heart rhythm disorder associated with fainting, chest pain, palpitations and chronic heart failure.

One of the main selling points of Pradaxa is that it does not require frequent blood plasma monitoring, which is needed with the older drug warfarin (coumadin). But many patients using the anticoagulant have reported Pradaxa internal bleeding problems.

When a patient uses an anticoagulant, there is an inherent risk of internal bleeding. What makes Pradaxa considerably more dangerous than warfarin is that Pradaxa bleeding events cannot be stopped. When a patient experiences internal bleeding related to warfarin use, the bleeding can be stopped with a shot of Vitamin K. No Pradaxa antidote exists.

Because there is no effective way to stop Pradaxa bleeding, the risk of serious injury or death is greater than with other blood thinners.

Manufacturer Fails to Disclose Pradaxa Bleeding Risks

According to the British Medical Journal’s report, Boehringer Ingelheim Pharmaceuticals failed to disclose that patients fare better when their plasma levels are monitored during treatment. Pradaxa patients also benefited from adjusted doses to make sure the drug maintains a safe level.

Internal documents that Boehringer Ingelheim Pharmaceuticals produced during litigation included calculations of how many Pradaxa bleeding events could be prevented by regulating patient dosages.

While the German drug maker provided the FDA with all of the underlying data, the only actual analysis that was provided was one that indicated that the number of people who died from Pradaxa bleeding events was less than expected.

According to Boehringer Ingelheim Pharmaceuticals, it did not disclose these analysis results because they did not predict patient outcomes. But internal documents between Boehringer Ingelheim Pharmaceuticals employees suggest that the research results were hidden because they could hurt Pradaxa sales.

Pradaxa Bleeding Lawsuits

Injured Pradaxa users and their family members began filing personal injury lawsuits against Boehringer Ingelheim Pharmaceuticals in 2012. Since then, the number of Pradaxa lawsuits has climbed into the thousands. Some of the allegations against the drug maker state that Boehringer Ingelheim hid the risks of internal bleeding, failed to research proper dosing, and failed to require instructions for care during a patient’s use of the drug.

Boehringer Ingelheim Pharmaceuticals announced in May 2014 that it had agreed to pay $650 million to settle approximately 4,000 Pradaxa lawsuits. The settlement includes Pradaxa lawsuits at both the state and federal levels. The Pradaxa settlement amounts averaged about $162,000 per plaintiff.