In 2010 when the drug Pradaxa hit the market, it was said to better than any other blood thinner available. Yet in a mere 2 years, this blockbuster drug has unfortunately seen nothing but problems. Including studies suggesting that it isn’t, as previously thought, a better alternative to other blood thinners, such as Warfarin.
Since Pradaxa’s October 2010 approval, concerns over serious side effects have grown. Like any blood thinner, both Warfarin and Pradaxa pose a risk of serious bleeding. However, Warfarin bleeding can be stopped with the administration of vitamin K or a drug called recombinant factor VIIa. There is currently no practical antidote for Pradaxa bleeding.
The FDA announced in December 2011 that it had launched a Pradaxa safety review because of reports of fatal bleeding. Weeks after the FDA announced the beginnings of its review, the Institutes for Safe Medicine Practices released reports showing that over 500 cases of Pradaxa-linked bleeding were reported to the FDA during the first quarter of 2011.