EMA starts review on screening patients before treatment with fluorouracil, capecitabine, tegafur and flucytosine

EMA has started a review of medicines containing fluorouracil (also known as 5-fluorouracil or 5-FU) and the related medicines capecitabine, tegafur and flucytosine, which are converted to fluorouracil in the body. The review will examine existing screening methods and their value in identifying patients at increased risk of severe side effects.

First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban

EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Ondexxya (andexanet alfa). This medicine is to be used as an antidote for adult patients taking the anticoagulant (clot-preventing) medicines  apixaban or rivaroxaban , when reversal of their action is needed  due to life-threatening or uncontrolled bleeding .