July 23, 2014 — The safety of patients on Pradaxa (dabigatran) might be improved with routine blood tests and lower starting doses, but this information was concealed by Boehringer Ingelheim, according to the British Medical Journal.
Dr. Deborah Cohen, investigations editor for the BMJ, said Boehringer produced an “extensive analysis” showing a 30-40% reduction in major bleeding for Pradaxa patients who were monitored more closely.
Instead of sharing this information with doctors, Boehringer marketed Pradaxa as a safe and effective alternative to warfarin. Unlike warfarin, which requires frequent dosage adjustments and blood tests, Pradaxa is a once-daily or twice-daily pill.
Pradaxa may be easier to use, but safety is still an open question. The BMJ cited federal statistics linking Pradaxa to 542 deaths and 2,400 hemorrhages in 2011. During the same time period, warfarin was linked to 72 deaths.
Dr. Cohen warned:
“[Boehringer] 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. The company also withheld analyses that calculated how many major bleeds dose adjustment could prevent.”
The BMJ also published an editorial by experts who warned that Pradaxa has “fickle pharmacokinetics, which can cause a five-fold variation of plasma concentration.” High concentrations of Pradaxa in the bloodstream significantly increase a patient’s risk of bleeding.
The editorialists also raised concerns about the reliability of data and “design and oversight” issues with the RE-LY clinical trial, which established Pradaxa’s safety.
Conclusions were partly based on evidence unsealed in litigation. Earlier this year, Boehringer agreed to settle up to 4,000 Pradaxa lawsuit for $650 million.
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