The United States Food and Drug Administration has approved United States-based Boehringer Ingelheim Pharmaceuticals' Pradaxa (dabigatran etexilate mesylate
), it was reported yesterday.
Dabigatran etexilate mesylate
(Pradaxa; Boehringer Ingelheim Pharmaceuticals, Inc., https://www.pradaxa.com/) provided practitioners and their patients with a new, very different, and effective approach to anticoagulation.
FDA drug safety communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate
has announced that the FDA has approved Pradaxa (dabigatran etexilate mesylate
) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.
 FDA Briefing Information, Dabigatran Etexilate Mesylate
Capsules, for the September 20, 2010 Meeting of the Cardiovascular and Renal Drugs Advisory Committee, 2013, http:// www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdv- isoryCommittee/UCM247244.pdf.
The Food and Drug Administration has already approved three such medications -- apixaban (Eliquis), dabigatran etexilate mesylate
(Pradaxa) and rivaroxaban (Xarelto) -- and others are being studied.
The FDA has advised pharmacists to dispense the anticoagulant medication dabigatran etexilate mesylate
(Pradaxa) only in the original manufacturer bottles or blister packages because of concerns about product breakdown, according to a MedWatch statement.
Presently, the product is being investigated to specifically reverse the anticoagulant effect of dabigatran, the active ingredient in Pradaxa (dabigatran etexilate mesylate
) in patients requiring emergency intervention or experiencing an uncontrolled or life-threatening bleeding event.
If approved, this will become the fourth indication for Pradaxa (dabigatran etexilate mesylate