BMJ Criticizes Pradaxa’s Path to Market, Recommends Dose Monitoring


Pradaxas-Approval-Route-Pushes-Dose-MonitoringDocuments published on Friday in the British Medical Journal (BMJ) allege that Boehringer Ingelheim withheld important data from regulators about the safety of its blood thinner dabigatran (Pradaxa) as the drug was under review for approval in nonvalvular atrial fibrillation (AF).

According to the reports, the company didn’t share its own analysis with US or European regulators suggesting a steep drop in the risk of internal bleeding when the drug dose was determined with guidance from blood monitoring, Medscape reports. That information in the hands of regulators, they contend, would have likely undermined the key dabigatran marketing message that no such monitoring was needed—in contrast to the regular monitoring required with the warfarin, the older drug Pradaxa was intended to replace. Pradaxa is the first of a new group of blood thinners that  claim not to need the blood monitoring that warfarin patients must regularly undergo.

The BMJ reports allege the company did not share with regulatory agencies that some of its researchers concluded that using monitoring to guide dabigatran dosing “has the potential to provide patients an even better efficacy and safety profile than fixed-dose dabigatran and also a better safety and efficacy profile than a matched warfarin group.” The reports observe that there is evidence for “a potentially higher bleeding risk with dabigatran than has been stated” in published reports coming out of that one pivotal phase 3 trial, according to Medscape.

The BMJ also blasted the trial’s “design and oversight,” and criticized the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for conducting expeditious or incomplete reviews of the drug for its ultimate approvals for nonvalvular AF, Medscape reports.

Boehringer Ingelheim said in a statement that “many of the allegations made by BMJ were reported months ago in the media and have been previously addressed in full by Boehringer Ingelheim.”