The unsafe profile of lecanemab.

Lack of data from the US Food and Drug Administration (FDA) Adverse Event System makes analyses of the risks of newly approved anti-Alzheimer's antibodies inadequate to determine whether such risks justify the minimal clinical benefits reported. A recent disproportionate analysis in the Journal of Alzheimer's Disease by Ge et al. is a case in point. Among serious adverse effects, it only addresses amyloid associated imaging abnormalities, whereas the even more threatening ones, brain tissue loss and therapy-related death, are not mentioned. We urge the FDA to prioritize monitoring of all adverse effects and encourage transparency from the drug manufacturers.