Monitoring, Dosing Adjustments could Minimize Pradaxa Bleeding Events, Investigation Finds

An investigation by Deborah Cohen of the British Medical Journal (BMJ) has revealed that Pradaxa manufacturer Boehringer Ingelheim may have withheld analyses that might have prevented some Pradaxa bleeding events. Monitoring and dosing adjustments could make use of the drug even safer and more effective, according to Cohen’s findings. However, the company failed to share analyses regarding this fact with regulators in the U.S. or Europe.

Internal documents from Boehringer Ingelheim showed that the company had discovered potential benefits of monitoring patient’s anticoagulant activity, and that adjusting Pradaxa dosage as indicated from that monitoring could reduce the risk of potentially dangerous bleeding risks. However, the company failed to share that information with regulators prior to the drug’s approval. The company also withheld analyses regarding how many patients could have been saved bleeding incidents by these measures.

“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,” Cohen wrote after her investigation.

About Pradaxa

Pradaxa was introduced to the U.S. market in 2010 and marketed as a convenient alternative to the older blood-thinning drug warfarin. Unlike warfarin, Pradaxa came with a single dosing regimen and required no ongoing monitoring to ensure the patient’s blood levels were within safe levels while on the drug. These purported benefits were one of the main factors in the drug’s quick climb to blockbuster status.

Soon after Pradaxa was introduced, alarming reports of serious Pradaxa side effects began to surface. Patients who experienced uncontrollable bleeding while on Pradaxa discovered that unlike warfarin, physicians were unable to reverse its effects. Patients who begin to bleed on warfarin can be given vitamin K to reverse the anticoagulant effect of the drug. No such antidote exists for Pradaxa at this time.

The lack of an antidote has led to uncontrollable bleeding and even death in some Pradaxa users. Gastrointestinal bleeding is of particular concern. Earlier this year, the FDA issued a drug safety communication warning that the risk of a gastrointestinal bleed was higher in patients taking Pradaxa than in those taking warfarin. The new findings were based on a larger and older patient population than prior studies conducted by the agency.

Pradaxa litigation

Many patients that have suffered Pradaxa bleeding events have taken their complaints to court, alleging Boehringer Ingelheim failed to provide proper warning about the risks associated with their drug.

Boehringer Ingelheim recently reached a settlement agreement with approximately 4,000 of those plaintiffs, totaling $650 million. The average settlement amount for these injured plaintiffs is estimated to be around $165,000. Pradaxa lawsuits not covered by the settlement will continue to move toward trial in the courts.

Boehringer Ingelheim has stated that the Pradaxa settlement agreement does not include an admission of wrongdoing on the part of the company. The drug manufacturer has also responded to the BMJ investigation, stating, “Our scientists determined, and the FDA concurred, that the research does not support making dosing decisions based on plasma concentrations – a conclusion based solely on science and patient welfare.”

It is unknown at this time if findings by BMJ will spur further questions by regulators or legislators in the U.S. or around the globe.

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