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Keyword: rexulti

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  • Alarm as FDA fast-tracks first antipsychotic for dementia agitation

    09/25/2023 8:44:07 AM PDT · by bitt · 26 replies
    bmj.com ^ | 8/17/2023 | bmj.com
    Investigation raises serious questions about the harm-benefit balance of Rexulti Decision may reverse efforts to reduce use of antipsychotics in US care homes In trials, the antipsychotic drug brexpiprazole (Rexulti) failed to provide a clinically meaningful benefit and increased the risk of death. Yet the US Food and Drug Administration (FDA) has fast tracked its approval, making Rexulti the first antipsychotic for treating agitation in elderly patients with dementia. At a cost of around $1,400 a month Rexulti’s makers, Otsuka and Lundbeck, are forecasting an additional $1 billion in annual sales, but there are serious questions about the harm-benefit balance...