Quoted from http://online.wsj.com/article/BT-CO-20120525-703257.html
EMA Recommends Patient, Prescriber Information For Pradaxa Be Updated
- May 25, 2012, 5:17 a.m. ET
LONDON (Dow Jones)--The European Medicines Agency, or EMA, Friday recommended updating the product information for the blood thinner Pradaxa, to give clearer guidance to doctors and patients on how to reduce and manage the risk of bleeding associated with the anticoagulant medicine.
-Bleeding is a well-known complication of all anticoagulant medicines and Pradaxa has therefore been kept under close review by the Agency's Committee for Medicinal Products for Human Use, or CHMP, since its initial authorization.
-Committee's recommendation to update the product information follows the assessment of all available data, including from post-marketing surveillance, on Pradaxa and the risk of serious or fatal bleedings.
-Committee found that the frequency of occurrence of fatal bleedings with Pradaxa seen in post-marketing data was significantly lower than what was observed in the clinical trials that supported the authorization of the medicine, but considered that this issue should nonetheless be kept under close surveillance.
-CHMP concluded that the benefits of Pradaxa continue to outweigh its risks and that it remains an important alternative to other blood-thinning agents.