We are watching to see whether the FDA and/or European drug regulators require a Pradaxa liver injury label change adding a new warning about an increased risk of acute liver failure and drug-induced hepatitis — like what was done in Japan last year and is being done now in Canada. In May 2018 Health Canada announced that their Pradaxa drug … [Read more...]
Expanding Treatment Options for Bleeds Related to Oral Anticoagulants
UPDATE: The FDA announced that it will push back its decision on whether to approve the reversal agent AndexXa to May 4, 2018. The original review date was set for February 3, 2018, but the FDA wanted to consider additional information it had requested from Portola, the drug's manufacturer. (12/28/17). Risk of Bleeding … [Read more...]
Pradaxa vs. Warfarin: Rehospitalizations For Serious Bleeding Events
Thomas J. Moore, of the Institute for Safe Medication Practices, recently wrote a “Perspective” piece about new Pradaxa-versus-warfarin study, which is described below. Medical researchers reviewed population-wide electronic medical records from the Clinical Data Analysis and Reporting System of the Hong Kong Hospital Authority to identify the … [Read more...]
New Anticoagulant BevyxXa Approved by the FDA
On June 23, 2017, a new anticoagulant drug called BevyxXa (betrixaban) was approved by the FDA for the prevention of venous thromboembolism and pulmonary embolism. This drug acts as a direct Factor Xa inhibitor, similar to the other anticoagulant drugs Eliquis, Savaysa, and Xarelto. Unlike the anticoagulant Pradaxa, which is a direct … [Read more...]
Pradaxa And Xarelto May Double The Risk Of Heart Attacks Some Patients
In March 2017 the British Journal of Clinical Pharmacology published this article, “Risk of myocardial infarction in patients with atrial fibrillation using vitamin K antagonists, aspirin or direct acting oral anticoagulants”, which reports on the first retrospective cohort study to compare the risk of acute myocardial infarction (AMI), or heart … [Read more...]
Earlier Pradaxa Settlements Do Not Stop Filing Of New Pradaxa Lawsuits
As can be seen from the following set of drug safety alerts, Pradaxa has caused significant concern among doctors and patients since soon after it first became available for use in the US. In early December 2011 the FDA announced it would evaluate reports of bleeding in patients taking Pradaxa that have been submitted to the agency’s Adverse … [Read more...]
Warfarin vs. Eliquis, Pradaxa, Xarelto, and Savaysa: Which is Better?
There in an ongoing debate amongst medical professionals concerning the effectiveness and safety of warfarin in comparison to the non–vitamin K antagonist oral anticoagulants (NOACs)--such as Eliquis, Xarelto, Savaysa, and Pradaxa--for patients with atrial fibrillation. According to the Healio Cardiology today article, "Merits of warfarin, newer … [Read more...]
What’s in a Name? Debate on What to Call Novel Oral Anticoagulants
Recently, controversy has arisen over what to call the novel oral anticoagulant class of drugs, which includes Pradaxa, Xarelto, Savaysa, and Eliquis. The article "NOAC, DOAC, or TSOAC: What Should We Call Novel Oral Anticoagulants?" provides some interesting information about the different sides of this debate. Here is a list of the possible … [Read more...]
New Studies Investigate Long-Term Anticoagulation Use & Bleeding Risk
According to a Patient-Centered Outcomes Research Institute (PCORI) press release from earlier this month, the PCORI Board of Governors approved $6.5 million for research to compare the potential benefits and harms of popular anticoagulant drugs. The study will include the older anticoagulant, Coumadin (warfarin), as well as the newer "novel … [Read more...]