The myths behind DOAC measurement: Analyses of prescribing information from different regulatory bodies and a call for harmonization.

ABSTRACT: For more than a decade, US laboratories have failed to implement solutions to help their clinicians in managing complex situations or patients on direct oral anticoagulants (DOACs). The problem may find different origins, among which is the position of the Food and Drug Administration, which categorized these drugs as monitoring- and measurement-free, whereas other regulatory bodies like the European Medicines Agency or the Therapeutic Goods Administration in Australia were more conservative on the principle that the absence of proof (of monitoring/measurement benefits) is not proof of an absence (of monitoring/measurement needs). Pivotal clinical studies that led to the approval of DOACs were presented as devoid of such testing, although some companies considered monitoring as a solution

SUBMITTER: Gosselin RC 

PROVIDER: S-EPMC9828176 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature