January 26, 2019 – Pharmacogenomic approaches are increasingly revealing newly identified genes and genetic variants that are at the base of remarkable inter-individual pharmacokinetic and pharmacodynamic variation of novel direct oral anticoagulants (DOAC). Lately, DOACs have shown an upward prescribing trend due …

Direct Oral Anticoagulants (DOAC): Newly Identified Genes and Genetic Variants Read more »

December 16, 2015 – This post is somewhat delayed; however, it may still be of  interest for some readers of thasso post and therefore, the information is provided here uncommented, as it was issued by both the FDA and the EMA …

Idarucizumab (Praxbind): Antidote for Dabigatran (Pradaxa) approved by FDA and recommended for approval by EMA Read more »

May 13, 2014 – The Pradaxa story continues. See the latest MedWatch Drug Safety Communication, posted on 05/13/2014. ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke,  bleeding …

Dabigatran (Pradaxa) Drug Safety Communication: Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin Read more »

December 12, 2011 – This is from a press release from December 07, 2011: FDA is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes …

Dabigatran [Pradaxa]: Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events Read more »