Euro regulators seek new safety guidance on Pradaxa


Euro regulators seek new safety guidance on PradaxaEuropean health regulators have asked for more specific information to provide patients in order to avoid fatal bleeding episodes associated with the anti-clotting drug Pradaxa.

Pradaxa is a relatively new drug designed to supplant the decades-old standard prescription treatment for thinning blood in order to prevent heart attack and stroke, warfarin (Coumadin). In recent months, a growing number of reports has associated taking Pradaxa with a serious bleeding risk that’s often proved fatal because the drug has no known antidote.

Specifically, brain and gastrointestinal hemorrhaging have been reported after some patients suffered just minor falls. What starts as minor bleeding soon escalates in severity and physicians have been unable to stem the excessive bleeding. Warfarin does have an antidote and does not carry the same severe bleeding risk.

According to a Reuters report late last week, the European Medicines Agency has asked the German-based makers of Pradaxa, Boehringer-Ingelheim, to develop updated guidance for physicians prescribing the drug to avoid this risk. The agency still believes the clinical benefits to taking Pradaxa outweigh this and any other risks associated with taking it.

Boehringer has admitted that more than 250 people taking Pradaxa have suffered fatal bleeding episodes but believes this total was expected prior to it being approved worldwide.