Alarm as FDA Fast-tracks First Antipsychotic for Dementia Agitation (Premium)

Press release: The British Medical Journal investigative unit has raised serious questions about the harm-benefit balance of the new drug Rexulti. The US Food and Drug Administration (FDA) has fast tracked the approval of Rexulti, the first antipsychotic for treating agitation in elderly patients with dementia. Yet in the three pre-approval trials, the FDA concluded that the death rate was four times higher in those given brexpiprazole compared to those given placebo.

At a cost of around $1,400 a month, Rexulti’s makers are forecasting an additional $1 billion in annual sale.