Monitoring, Dose Adjustment for Pradaxa?
From the article:
Blood level monitoring and dose adjustment for dabigatran (Pradaxa) could reduce major bleeding risk by 40% compared with well-controlled warfarin, according to company documents allegedly hidden from physicians and regulators
An investigation by The BMJ released online in the journal concluded that “recommendations for use of new generation oral anticoagulants may be flawed because regulators did not see evidence showing that monitoring drug plasma levels could improve safety.”
“The company also withheld analyses that calculated how many major bleeds dose adjustment could prevent. The company says that this information was not shared because the analysis did not provide a reliable prediction of patient outcomes,” wrote BMJ investigations editor Deborah Cohen.
Profits over safety ?
Filed under: General Problems
Is that another “bad drug ad” I hear gearing up in the backround?