Health Canada and European Medicines Agency have decided to reintroduce the use of aprotinin after its withdrawal from the worldwide market in 2007.
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"This analysis is about setting the record straight and refuting the inaccurate and unclear criticisms made against the BART trial regarding the way it was conducted and its final results reported," says Dean Fergusson, senior scientist and director of the Clinical Epidemiology Program at the Ottawa Hospital Research Institute and a professor at the University of Ottawa. "We want to reassure all those involved in BART, including physicians, nurses, patients and families, that it was a pivotal, well-designed and well-conducted trial."
Aprotinin is still unavailable for use in the United States.
"We consider that the prudent regulatory response to uncertainty would have been to mandate a second large trial comparing aprotinin to an active agent to either refute or confirm results from the BART," the authors conclude.
Source-Eurekalert