Byfavo: which risks did reviewers probe?

“There were no findings indicating an influence of remimazolam on the immune system.”

“Placenta penetration of remimazolam and/or its derivatives was very limited and did not lead to a sustained exposure of the fetus. Remimazolam and/or its derivatives easily accessed breast milk; the concentrations determined in milk were linked to maternal plasma concentrations.”

“Of specific concern, data from the rat studies did not provide acceptable safety margins as the DART studies were conducted with short boluses that resulted in systemic exposures below that in humans.”