Boehringer Ingelheim, the manufacturer of the popular blood thinner Pradaxa (dabigatran), has been accused of withholding important drug safety information, allegedly leading to numerous patient injuries and  death.

On July 23, the journal BMJ published a set of articles that suggest Boehringer may have known about dangerous Pradaxa side effects, but failed to report this drug safety information to drug regulators. As an anticoagulant, Pradaxa is meant to reduce a patient’s risk of stroke, especially individuals suffering from atrial fibrillation and heart rhythm disorder.

When the blood thinning medication was first introduced to the U.S. drug market in 2010, Pradaxa had been marketed as a superior and more convenient anticoagulant than the established Warfarin (coumadin).

According to Boehringer’s marketing for its blockbuster drug, Pradaxa did not require patients to undergo frequent blood plasma monitoring. However, there is no reversal agent available to patients who suffer from Pradaxa bleeding complications.

Some researchers became curious to know if blood monitoring, as is required with Warfarin, would be helpful to patients on the newer anticoagulant. Researchers from the Institute for Safe Medication Practices (ISMP) located at the University of Ottawa were able to examine the drug manufacturer’s data to determine the impact blood monitoring has on Pradaxa use.

Results of Pradaxa Study

According to the ISMP’s report, the researchers discovered that had Pradaxa patients undergone periodic blood level monitoring, a doctor would have been able to adjust, lower, or even temporarily discontinue patients’ dosages if they had a dangerous level of Pradaxa in their system that would have put them at risk of an injurious or fatal bleeding event.

The ISMP report states that Boehringer’s own data suggest a simple blood test could have prevented up to 40 percent of all serious Pradaxa bleeding events and deaths.

In the report, the researchers claim Pradaxa’s manufacturer had been aware of the Pradaxa side effects including uncontrollable internal bleeding, prior to FDA approval, but chose to withhold this information from federal regulators during the Pradaxa drug approval process. This new study cites four internal drug reports from Boehringer Ingleheim scientists concerned with risk of serious Pradaxa bleeding complications, but were ignored by superiors within the company.

Investigations editor Deborah Cohen commented on the results of its Pradaxa studies, saying: “Boehringer Ingelheim, the maker of dabigatran, has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible.”

Despite these and other Pradaxa bleeding studies, and adverse event reports of patients experiencing internal bleeding complications, Boehringer maintains that its popular anticoagulant is safe.