The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reviewed all available data at world level on the risk of fatal bleeding following administration of PRADAXA, an anticoagulant containing dabigatran. The risk of bleeding of the anticoagulants is well known and is already included in the summary of product characteristics (SPC) and Package Leaflet of PRADAXA. The CHMP considers it necessary to strengthen precautionary measures in case of kidney failure. The doctors were informed. The SPC and package leaflet will be adapted along those lines.
See EMA Website.