The bad news keeps mounting about the new anticoagulant Pradaxa (see WDDTY, September and October). Its manufacturer has paid out $650m in lawsuits to settle claims of harm and death, and now researchers have discovered it also increases the chances of major bleeding.
Pradaxa (dabigatran) was already cited as the most dangerous drug by the FDA's drug monitoring service-with 542 deaths and 2,367 cases of haemorrhage in just one quarter-but now it's also been associated with life-threatening bleeding, and especially in the stomach.
Dabigatran patients were 58 per cent more likely to suffer a major bleeding episode compared to those taking the traditional anticoagulant warfarin, say researchers from the University of Pittsburgh. African-Americans with chronic kidney disease were twice as likely to suffer a major bleed while taking the drug compared to warfarin.
In all, the researchers tracked the health of 1,302 dabigatran patients and compared them with 8,102 warfarin users.
Dabigatran was licensed for use in 2010 after it was hailed as a breakthrough blood thinner, as the patient did not have to be constantly monitored, one of the major down-sides of using warfarin.
(Source: JAMA Internal Medicine, 2014; doi: 10.1001/jamainternmed.2014.5398)